| 372 | | | 4/1/2024 | Rx.01.285 | Commercial | Oyenusi, Oluwadamilola | Q4-2023 | Patients with established cardiovascular disease (CVD) have a high risk of subsequent CVD events, including myocardial infarction (MI), stroke, and death. Therapeutic lifestyle changes, which include increased physical activity, dietary modification/weight loss, and smoking cessation are of proven benefit and improve outcomes beginning within a matter of weeks. In addition, adjunctive drug therapies of proven benefit include statins and aspirin, whose benefits are at least additive.
The mechanism of action of colchicine in the prevention of major cardiovascular events is not understood. However, it is known that colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules and consequently prevents the activation, degranulation, and migration of neutrophils. Colchicine may also interfere with the intracellular assembly of the inflammasome complex in neutrophils and monocytes that mediates activation of interleukin-1β. These anti-inflammatory effects are consistent with clinical data demonstrating that colchicine reduces high sensitivity C- reactive protein (hs-CRP).
Lodoco is indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. | The intent of this policy is to communicate the medical necessity criteria for Colchicine (Lodoco) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Colchicine (Lodoco) is approved when all of the following are met: - Diagnosis of cardiovascular disease (CV); and
- Used for the secondary prevention of CV disease (e.g., very high-risk patients); and
- Member is 18 years of age or older; and
- Member is on guideline therapy management for multiple risk factors (e.g., dyslipidemia, hypertension, hyperglycemia) associated with CV disease
Initial authorization duration: 6 months REAUTHORIZATION CRITERIA: Colchicine (Lodoco) is re-approved when documentation is provided of positive clinical response to therapy Reauthorization duration: 6 months
| | | Hennekens CH, Lopez-Sendon J. Prevention of cardiovascular disease events in those with established disease (secondary prevention) or at very high risk. July 2023. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed February 15, 2024.
Lodoco (colchicine) [prescribing information]. Parsippany, NJ: AGEPHA Pharma USA, LLC. June 2023. Available from: https://lodoco.com/. Accessed February 15, 2024.
| 1 | 12/18/2023 | 12/18/2024 | 4/1/2024 1:29 AM |   srv_ppsgw_P | | | LODOCO TAB 0.5MG | COLCHICINE (CARDIOVASCULAR) TAB 0.5 MG | | 375 | | | 4/1/2024 | Rx.01.287 | Commercial | Oyenusi, Oluwadamilola | Q4-2023 | FOP, or myositis ossificans progressiva, is an ultra-rare, genetic connective tissue disorder characterized by severe,
progressive development of bone in areas outside of the skeleton (heterotopic ossification; HO), such as the ligaments,
tendons, and muscles. The hallmark symptom of FOP is malformation of the big toes at birth. Episodes of painful soft
tissue swelling, known as flare-ups, begin during the first decade of life, and these are often precipitated by soft tissue
injury, intramuscular injections, viral infections, or falls. These flare-ups may lead to extraskeletal HO, which progresses
throughout life. Over time, HO eventually leads to stiffness in affected areas, limited movement, and eventual ankylosis
(fusion) of affected joints. Many individuals with FOP are confined to a wheelchair by their 30s, requiring lifelong
assistance with activities of daily living. The estimated median lifespan of individuals with FOP is 56 years; death is often
due to cardiorespiratory failure as a result of severe restriction of the chest wall.
FOP is caused by mutations in the activin A receptor type 1 gene (ACVR1), which encodes a bone morphogenetic protein
(BMP) type I receptor that is important during the formation of the skeleton in the embryo and the repair of the
skeleton following birth. The mutation in the ACVR1 gene increases BMP signaling, resulting in the formation of
heterotopic bone. Approximately 97% of patients with FOP have the same ACVR1 point mutation (arginine to histidine
[R206H]), which is considered classic FOP. Most cases of FOP occur sporadically; however, in a small number of cases,
the condition is inherited in an autosomal dominant pattern.
The diagnosis of FOP may be confirmed by clinical evaluation, characteristic physical findings, and sequencing of
the ACVR1 gene.
In patients with FOP, abnormal bone formation, including heterotrophic ossification (HO), is driven by
a gain-of-function mutation in the bone morphogenetic protein (BMP) type I receptor ALK2 (ACVR1).
Palovarotene is an orally bioavailable retinoic acid receptor agonist, with particular selectivity at the
gamma subtype of RAR. Through binding to RARγ, palovarotene decreases the BMP/ALK2
downstream signaling pathway by inhibiting the phosphorylation of SMAD1/5/8, which reduces
ALK2/SMAD-dependent chondrogenesis and osteocyte differentiation resulting in reduced
endochondral bone formation.
SOHONOS is a retinoid indicated for reduction in the volume of new
heterotopic ossification in adults and children aged 8 years and older
for females and 10 years and older for males with fibrodysplasia
ossificans progressiva (FOP) | The intent of this policy is to communicate the medical necessity criteria for palovarotene (Sohonos®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Palovarotene (Sohonos) is approved when all of the following are met: - Diagnosis of Fibrodysplasia Ossificans Progressiva (FOP); and
- Molecular genetic testing confirms mutations in the ACVR1 gene; and
- One of the following:
- Both of the following:
- Member is female; and
- Member is 8 years of age or older; or
- Both of the following:
- Member is male; and
- Member is 10 years of age or older; and
- Prescribed by or in consultation with one of the following:
- Geneticist; or
- Orthopedic physician
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Palovarotene (Sohonos) is re-approved if documentation is provided that member demonstrates positive clinical response to therapy (e.g., reduction in volume in new abnormal bone growth) Reauthorization duration: 12 months
|
| WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN
GROWING PEDIATRIC PATIENTS
Embryo-Fetal Toxicity
SOHONOS is contraindicated in pregnancy. SOHONOS may cause fetal harm. Because of
the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered
only if conditions for pregnancy prevention are met. Premature Epiphyseal Closure
Premature epiphyseal closure occurs in growing pediatric patients treated with
SOHONOS, close monitoring is recommended
| | | 1 | 12/18/2023 | 12/18/2024 | 4/1/2024 1:29 AM | srv_ppsgw_P | | | Sohonos® | palovarotene | | 382 | | | 7/1/2024 | Rx.01.158 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Allergic rhinitis is a persistent condition that typically requires ongoing therapy. Allergen avoidance along with pharmacologic therapy with nasal corticosteroids and oral antihistamines are standard management. Allergen immunotherapy is reserved for severe or refractory cases. Sublingual immunotherapy involves the application of the allergen to the sublingual tissue. In the case of Odactra™, Oralair®, Grastek®, and Ragwitek®, the allergen is in a sublingual tablet which is self-administered, after the first dose. The exact mechanism of sublingual allergen immunotherapy has not been fully elucidated. Allergen extracts given sublingually are primarily taken up by dendritic cells in the mucosa and presented to T cells in the draining lymph nodes. Likely mechanisms of action include activation of T regulatory cells and downregulation of mucosal mast cells. Within the oral and sublingual mucosa, effector cells, such as mast cells, are less numerous, which may account for the lower rates of adverse systemic allergic reactions seen with sublingual immunotherapy. Timothy grass pollen allergen extract (Grastek®) is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens in persons 5 through 65 years of age. Short ragweed pollen allergen extract (Ragwitek®) is indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen in individuals 5 through 65 years of age. Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract (Oralair®) is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product in persons 10 through 65 years of age. Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mite allergen extract (Odactra™) is indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. Odactra™ is approved for use in individuals12 through 65 years of age.
| The intent of this policy is to communicate the medical necessity criteria for house dust mite allergen extract (Odactra™), grass pollen allergen extract-5 grass (Oralair®), grass pollen allergen extract-timothy grass (Grastek®), and short ragweed pollen allergen extract (Ragwitek®) as provided under the member’s prescription drug benefit.
| INITIAL CRITERIA: Odactra™, Oralair®, Grastek® or Ragwitek® is approved when ALL of the following are met: - FDA approved indication; and
- Patient has a positive skin test or in vitro test for ONE of the listed pollen-specific IgE antibodies:
- Timothy Grass or cross-reactive grass pollens (GRASTEK® only); or
- Any of the five grass species including sweet vernal, orchard perennial rye, timothy or Kentucky blue grass mixed pollens (ORALAIR® only); or
- Short ragweed pollen (RAGWITEK® only); or
- Dermatophagoides farina or Dermatophagoides pteronyssinus house dust mites (ORDACTRA™ only); and
- Prescribed by or in consultation with allergist or immunologist and
- ONE of the following:
- For Grastek, member is between 5 to 65 years of age; or
- For Odactra, member is between 12 to 65 years of age; or
- For Oralair, member is between 5 to 65 years of age; or
- For Ragwitek, member is between is 5 to 65 years of age; and
- Patient does not have any of the following:
- Severe, unstable or uncontrolled asthma; or
- History of eosinophilic esophagitis; and
- Patient has had an inadequate response or inability to tolerate BOTH of the following:
- Intranasal corticosteroid; and
- Antihistamine
Initial Authorization duration: 1 year
REAUTHORIZATION CRITERIA: Odactra™, Oralair®, Grastek® or Ragwitek® is re-approved when ALL of the following are met: - Use in the age group supported by FDA labeling; and
- Prescribed by or in consultation with allergist or immunologist; and
- Patient has experienced improvement in the symptoms of their allergic rhinitis OR a decrease in the number of medications needed to control allergy symptoms
Reauthorization duration: 1 year
| Severe allergic reactions: Odactra™, Grastek®, Oralair® and Ragwitek® can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer Odactra™, Grastek®, Oralair® and Ragwitek® to patients with severe, unstable or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Odactra™, Grastek®, Oralair® and Ragwitek® may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. Odactra™, Grastek®, Oralair® and Ragwitek® may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
| | Creticos PS. Sublingual immunotherapy (SCIT) for allergic rhinoconjunctivitis and asthma. UpToDate. Available at: http://www.uptodate.com/contents/sublingual-immunotherapy-for-allergic-rhinoconjunctivitis-and-asthma. Accessed April 17, 2024. De Shazo RD, Kemp SF. Pharmacotherapy of allergic rhinitis. UpToDate. Available at: https://www.uptodate.com/contents/pharmacotherapy-of-allergic-rhinitis?search=pharmacotherapy-of-allergic-rhinitis.&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed April 17, 2024. Grastek® (Timothy grass pollen allergen extract) [package insert]. Whitehouse Station NJ. Merck and Co, Inc. December 2019. Accessed April 17, 2024. Odactra™ (and house dust mite allergen extract) [package insert]. Whitehouse Station NJ. Merck and Co, Inc. January 2023. Available from: https://www.odactra.com/assets/pdf/odactra-full-pi.pdf. Accessed April 17, 2024. Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) [package insert]. Lenoir NC. Greer Laboratories, Inc. November 2018. Accessed April 17, 2024. Ragwitek® (short ragweed pollen allergen extract) [package insert]. Whitehouse Station NJ. Merck and Co, Inc. April 2021. Accessed April 17, 2024.
| 14 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:22 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Grastek® | grass pollen allergen extract-timothy grass | | Oralair® | grass pollen allergen extract-5 grass | | Ragwitek® | short ragweed pollen allergen extract | | Odactra™ | house dust mite allergen extract |
| NA | NA | | 383 | | | 7/1/2024 | Rx.01.216 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Lambert-Eaton myasthenic syndrome (LEMS) is a rare autoimmune disorder of the neuromuscular junction. LEMS is associated with reduced acetylcholine (ACh) release from the presynaptic nerve terminals. Antibodies directed against the voltage-gated calcium channel (VGCC) interfere with the normal calcium flux required for the release of ACh from the presynaptic nerve terminal. The most common symptoms of LEMS include proximal muscle weakness, fatigue, autonomic symptoms such as dry mouth, sluggish pupillary light response, erectile dysfunction in men, and reduced tendon reflexes. LEMS patients can be divided into two groups: patients with LEMS associated with underlying malignancy (paraneoplastic LEMS) and those without malignancy (non-paraneoplastic LEMS). For patients with paraneoplastic LEMS, treatment of malignancy may be the only intervention necessary to produce improvement in neurologic symptoms of LEMS. Amifampridine (Firdapse®) is broad spectrum potassium channel blocker indicated for the treatment of LEMS in adults and pediatric patients 6 years of age and older. It blocks presynaptic voltage-gated potassium channels, prolonging the duration of the presynaptic action potential, lengthening the opening time of the VGCC, and increasing the presynaptic calcium levels. The increased calcium levels lead to an increase in the amount of ACh released. ACh then binds to muscle receptors and results in improved muscle function.
| The intent of this policy is to communicate the medical necessity criteria for amifampridine (Firdapse®) as provided under the member's prescription drug benefit
| INITIAL CRITERIA: Amifampridine (Firdapse®) is approved when ALL of the following are met: - Member has a diagnosis of Lambert-Eaton myasthenic syndrome; and
- Member is 6 years of age or older and
- Neurological symptoms persist after treatment of malignancy when malignancy is present; and
- Documentation of symptomatic LEMS that interfere with daily functions (e.g., difficulty climbing stairs, walking up steep hills); and
- Prescribed by or in consultation with a neurologist; and
- Member does not have history of seizures
Initial authorization duration: 3 months CONTINUATION CRITERIA: Amifampridine (Firdapse®) is re-approved when there is documentation of positive clinical response to therapy (e.g., improvement in dynamometry, Timed 25-Foot Walk Test, Timed Up and Go Test)
Reauthorization duration: 2 years
|
| | | Firdapse® (amifampridine) [prescribing information]. Coral Gables, FL: Catalyst Pharmaceuticals, Inc. September 2022. Available at: https://www.firdapse.com/pdfs/firdapse-pi.pdf. Accessed April 17, 2024. Titulaer MJ, Lang B, Verschuuren JJGM. Lambert-Eaton myasthenic syndrome: from clinical characteristics to therapeutic strategies. Lancet Neurol. 2011[a]; 10:1098-1107.
Weinberg DH. Lambert-Eaton myasthenic syndrome: Clinical features and diagnosis. UpToDate Web site. Updated March 2023. www.uptodate.com. Accessed April 17, 2024.
| 8 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:23 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Firdapse® | amifampridine phosphate
|
| NA | NA | | 384 | | | 7/1/2024 | Rx.01.225 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Diabetic foot ulcers are a prevalent complication of diabetes mellitus and represent major causes of morbidity and mortality. 15% of all diabetic individuals are affected by foot ulcers during their lifetime and 15-20% of those patients go on to need an amputation. Risk factors for development of diabetic foot ulcers include neuropathy, peripheral vascular disease, and poor glycemic control. Peripheral neuropathy results in patient loss of sensation and can exacerbate the development of ulcerations. Peripheral vascular disease can lead foot tissues to become ischemic. Many wounds go unnoticed and worsen through repetitive pressure because patients are unable to detect trauma to their lower extremities. Multidisciplinary treatment today includes: surgical debridement, dressings promoting a moist wound environment, wound off-loading, vascular assessment, treatment of active infection, and glycemic control. Regranex® gel is a recombinant human platelet-derived growth factor that promotes cellular proliferation and angiogenesis and thereby improve ulcer healing. Regranex® gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. Regranex® gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices.
| The intent of this policy is to communicate the medical necessity criteria for becaplermin (Regranex®) gel as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Becaplermin (Regranex®) gel is approved when BOTH of the following are met: - Member has a lower extremity diabetic neuropathic ulcer; and
- Treatment will be given in combination with ulcer wound care (e.g., debridement, infection control, and/or pressure relief)
Initial authorization duration: 6 months REAUTHORIZATION CRITERIA: Becaplermin (Regranex®) gel is re-approved when ONE of the following is met: - Documentation of lower extremity diabetic neuropathic ulcer at a different treatment site; or
- Documentation of continued need for treatment beyond 6 months
Reauthorization duration: 6 months
| | | | 5 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:23 AM | srv_ppsgw_P | | | Brand name | Generic name | | Regranex® | Becaplermin |
| NA | NA | | 385 | | | 7/1/2024 | Rx.01.203 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Systemic lupus erythematosus (SLE) is an autoimmune disorder that is very heterogeneous with respect to its severity and the organs affected. Approximately 1.5 million Americans, primarily women of childbearing age, have a form of lupus. SLE represents approximately 70% of all lupus cases. Common clinical manifestations of SLE include pain, extreme fatigue, hair loss, cognitive issues, rashes (often the classic “butterfly rash”), arthritis and arthralgias. More severe clinical manifestations include renal, hematologic, or central nervous system involvement. SLE is often associated with relapses (which can be acute or chronic) and remissions. Lupus nephritis (LN) is a form of glomerulonephritis that constitutes one of the most severe organ manifestation of systemic lupus erythematosus (SLE). Most patients with SLE who develop LN do so within 5 years of an SLE diagnosis and in many cases, LN is the presenting manifestation resulting in the diagnosis of SLE. Treatment of LN usually involves immunosuppressive therapy, typically with mycophenolate mofetil or cyclophosphamide and with glucocorticoids, although these treatments are not uniformly effective. Within 10 years of an initial SLE diagnosis, 5 to 20% of patients with LN develop end-stage kidney disease.
BLyS, a B-cell survival factor, is overexpressed in patients with systemic lupus erythematosus (SLE) and other autoimmune diseases. Belimumab is an inhibitor that targets B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells by blocking the binding of BLyS to its receptors on B-cells. An intravenous (IV) formulation of belimumab was approved by the FDA in 2011.A subcutaneous formulation of the medication was approved by the FDA in July 2017. Benlysta® (belimumab) is indicated for the treatment of:
- Patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy
- Patients aged 5 years and older with active lupus nephritis who are receiving standard therapy.
- Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics. Use of Benlysta is not recommended in these situations.
Voclosporin is a calcineurin-inhibitor immunosuppressant. Activation of lymphocytes involve an increase in intracellular calcium concentrations that bind to the calcineurin regulatory site and activate calmodulin binding catalytic subunit and through dephosphorylation, activates the transcription factor Nuclear Factor of Activated T-Cell Cytoplasmic (NFATc). The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens.
Lupkynis™ (voclosporin) is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis
| The intent of this policy is to communicate the medical necessity criteria for belimumab (Benlysta®) and voclosporin (Lupkynis™) as provided under the member's prescription drug benefit.
| Systemic Lupus Erythematosus
INITIAL CRITERIA Belimumab (Benlysta®) is approved when ALL of the following are met: - Diagnosis of active systemic lupus erythematosus; and
- Autoantibody positive (ie, anti-nuclear antibody [ANA] titer greater than or equal to 1:80 or anti-dsDNA level greater than or equal to 30 IU/mL), antibodies to DNA [Anti-dsDNA], Anti-Smith [Anti-Sm]); and
- Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (eg, antimalarials [eg, hydroxychloroquine], corticosteroids, NSAIDs, or immunosuppressants); and
- Prescribed by or in consultation with a rheumatologist; and
- Member is 5 years of age or older
Initial Authorization duration: 6 months REAUTHORIZATION CRITERIA: Belimumab (Benlysta®) is re-approved when there is documentation of positive clinical response to therapy. Reauthorization duration: 2 years Lupus Nephritis
INITIAL CRITERIA Belimumab (Benlysta®) is approved when ALL of the following are met: - Member has active lupus nephritis confirmed by kidney biopsy; and
- Member is receiving standard therapy for lupus nephritis (e.g. corticosteroids, immunosuppressants, azathioprine); and
- Prescribed by or in consultation with a rheumatologist or nephrologist; and
- Member is 5 years of age or older
INITIAL CRITERIA Voclosporin (Lupkynis™) is approved when ALL of the following are met:
- Diagnosis of active lupus nephritis; and
- Member is 18 years of age or older; and
- Used in combination with mycophenolate mofetil and corticosteroids; and
- Prescribed by or in consultation with nephrologist or rheumatologist
Initial Authorization duration: 6 months REAUTHORIZATION CRITERIA: Belimumab (Benlysta®) or Voclosporin (Lupkynis™) is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
|
| Lupkynis™ (Voclosporin)
Malignancies and serious infections: Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
| | Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9. PMID: 31974366. Accessed April 17, 2024. Benlysta® [Package Insert]. Rockville, MD: Human Genome Sciences, Inc.; February 2023. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2fa3c528-1777-4628-8a55-a69dae2381a3&type=display. Accessed April 17, 2024. Gladman DD, Pisetski DS, Curtis MR. Clinical manifestations of systemic lupus erythematosus in adults. UpToDate. Waltham, MA: UpToDate Inc. https://www-uptodate-com.proxy1.lib.tju.edu/contents/overview-of-the-clinical-manifestations-of-systemic-lupus-erythematosus-in-adults?source=search_result&search=lupus&selectedTitle=1~150. Accessed on April 17, 2024. Lupus facts and statistics. Lupus Foundation of America Web Site. https://resources.lupus.org/entry/facts-and-statistics. Published 2017. Accessed April 17, 2024. Lupkynis™ (voclosporin) [prescribing information]. Rockville, MD: Aurinia Pharma U.S., Inc.; January 2021. Available from: https://d1io3yog0oux5.cloudfront.net/auriniapharma/files/pages/lupkynis-prescribing-information/FPI-0011+Approved+USPI++MG.pdf. Accessed April 17, 2024.
| 10 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:23 AM | srv_ppsgw_P | Rx.01.33 Off-Label Use Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Benlysta® | belimumab | | Lupkynis™ | voclosporin |
| NA | NA | | 386 | | | 7/1/2024 | Rx.01.262 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Immunoglobulin A nephropathy (IgAN) or Berger's disease is a condition that damages the glomeruli inside the kidneys and can cause kidney disease. The kidney gets inflamed and can cause the kidneys to leak blood and protein which leads to loss of kidney function and kidney failure. Budesonide is a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. Mucosal B-cells present in the ileum, including the Peyer's patches, express glucocorticoid receptors and are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. Through their anti-inflammatory and immunosuppressive effects at the glucocorticoid receptor, corticosteroids can modulate B-cell numbers and activity. It has not been established to what extent TARPEYO's efficacy is mediated via local effects in the ileum vs systemic effects.
TARPEYO is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
| The intent of this policy is to communicate the medical necessity criteria for Budesonide (Tarpeyo™) as provided under the member's prescription drug benefit.
| Budesonide (Tarpeyo™) is approved when ALL of the following are met: - Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy; and
- Member is 18 years of age or older; and
- Member is at risk of rapid disease progression (e.g., generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool); and
- Used to reduce proteinuria; and
- Estimated glomerular filtration rate (eGFR) greater than or equal to 35 ml/min/1.73 m2; and
- One of the following:
- Member has been on a minimum 90-day trial of maximally tolerated dose and will continue to receive therapy with one of the following:
- An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril); or
- An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan); or
- Member is unable to tolerate BOTH ACE inhibitors and ARBs; and
- Inadequate response or inability to tolerate another glucocorticoid (e.g., prednisone, methylprednisolone); and
- Prescribed by or in consultation with a nephrologist
Authorization duration: 9 months
| | | Tarpeyo (budesonide) [package insert]. Stockhelm, Sweden: Calliditas Therapeutics AB. December 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=938cada4-d6bf-4252-836f-dd40f9eadb4d. Accessed April 17, 2024.
Cattran DC. IgA nephropathy: Treatment and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 17, 2024.
| 3 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:23 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Tarpeyo™ | Budesonide |
| NA | NA | | 387 | | | 7/1/2024 | Rx.01.117 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Cystic fibrosis (CF) is an inherited disease that affects mucus and sweat produced by secretory glands. The cystic fibrosis conductance regulator (CFTR) is a chloride channel present at the surface of epithelial cells in multiple organs. Mutations in this gene alter its ability to regulate the transport of chloride, sodium, and bicarbonate, leading to thick secretions in the lungs, pancreas, and other organs. Thickening of mucus can provide an environment for bacteria to grow, leading to repeated infections. Mucus blockage prevents pancreatic digestive enzymes from reaching the small intestine, reducing fat and protein absorption, which can lead to malnourishment. CF also causes sweat to become salty, which can lead to dehydration and fatigue when sweat leaves the body. Approximately 30,000 people in the United States, and 70,000 worldwide, are living with cystic fibrosis (CF). Over 2000 mutations in the CFTR gene have been identified. The most common of which is the F508del mutation, affecting approximately 90% of those with CF. Approximately 50% of those with CF are homozygous for F508Del mutation. Other mutations in the CTFR gene include, but are not limited to: G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N and S549R,etc. Ivacaftor (Kalydeco®) Ivacaftor (Kalydeco®) is indicated for the treatment of CF in patients age 1 month and older who have one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data* as noted in the prescribing information. Ivacaftor is a potentiator of the CFTR protein, which promotes increased chloride transport by potentiating the gating (channel-open probability) of the CFTR protein, and improves the regulation of salt and water absorption and secretion in various tissues. Lumacaftor/ivacaftor (Orkambi®) Lumacaftor/ivacaftor (Orkambi®) is indicated for the treatment of CF in patients age 1 years and older who are homozygous for the F508del mutation in the CFTR gene*. The F508del mutation causes protein misfolding resulting in impaired processing and gating of the CFTR protein. Lumacaftor improves the conformational stability of F508del-CFTR, resulting in increased processing and gating activity. Ivacaftor adds the benefit of potentiating gating of the CFTR protein. *If genotype unknown, an FDA-cleared CF mutation test should be performed to detect the presence of the F508del mutation on both alleles of the CFTR gene. Elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta™) Elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta™) is indicated for the treatment of CF in patients aged 2 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. Elexacaftor and tezacaftor bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of F508del-CFTR to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone. Ivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface. *If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation. Tezacaftor/ivacaftor (Symdeko®) Tezacaftor/ivacaftor (Symdeko®) is indicated for the treatment of CF in patients age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the CFTR gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence*. Tezacaftor facilitates the cellular processing and trafficking of normal and select mutant forms of CFTR (including F508del-CFTR) to increase the amount of mature CFTR protein delivered to the cell surface. Ivacaftor is a potentiator of the CFTR protein, which facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface *If genotype unknown, an FDA-cleared CF mutation test should be performed to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing.
| The intent of this policy is to communicate the medical necessity criteria for ivacaftor (Kalydeco®), lumacaftor/ivacaftor (Orkambi®), elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta™), and tezacaftor/ivacaftor (Symdeko®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Ivacaftor (Kalydeco®) is approved when ALL of the following are met: - Diagnosis of cystic fibrosis (CF); and
- Member is 1 month of age or older; and
- Prescribed by or in consultation with a pulmonologist or specialist affiliated with a CF care center; and
- Presence of one mutation in the CFTR gene that is responsive to ivacaftor as noted in the Prescribing Information (if the patient's genotype is unknown, an FDA-cleared test must be used to detect the presence of CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test)
INITIAL CRITERIA: Lumacaftor/ivacaftor (Orkambi®) is approved when ALL of the following are met:
- Diagnosis of cystic fibrosis (CF); and
- Member is 1 year of age or older; and
- Prescribed by or in consultation with a pulmonologist or specialist affiliated with a CF care center; and
- Homozygous for the F508del mutation in the CFTR gene (if the patient's genotype is unknown, an FDA-cleared CR mutation test must be performed to determine the presence of the F508del mutation on both alleles of the CFTR gene)
INITIAL CRITERIA: Elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta™) is approved when ALL of the following are met: - Diagnosis of cystic fibrosis (CF); and
- Member is 2 years of age or older; and
- One of the following:
- Member has at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene as detected by an FDA-cleared cystic fibrosis mutation test; OR
- Member has at least one mutation in the CFTR gene that is responsive based on in vitro data to elexacaftor/tezacaftor/ivacaftor (Trikafta™) as noted in the Prescribing Information; and
- Prescribed by or in consultation with a pulmonologist or specialist affiliated with a CF care center
INITIAL CRITERIA: Tezacaftor/ivacaftor (Symdeko®) is approved when ALL of the following are met: - Diagnosis of cystic fibrosis (CF); and
- Member is 6 years of age or older; and
- Prescribed by or in consultation with a pulmonologist or specialist affiliated with a CF care center; and
- Documentation of one of the following:
- Member is homozygous for the F508del mutation; or
- Member has at least one tezacaftor/ivacaftor responsive mutation in the CFTR gene as noted in the Prescribing Information (If the patient's genotype is unknown, an FDA-cleared test must be used to detect the presence of CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test).
Initial Authorization duration: 2 years REAUTHORIZATION CRITERIA: Ivacaftor (Kalydeco®), Lumacaftor/ivacaftor (Orkambi®), Elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta™), or Tezacaftor/ivacaftor (Symdeko®) is re-approved when there is positive clinical response to therapy (e.g., improvement in lung function or decreased number of pulmonary exacerbations).
Reauthorization duration: 2 years
|
| | | Accurso FJ, Rowe SM, Clancy JP, et al. Effect of VX-770 in persons with cystic fibrosis and the G551D-CFTR mutation. N Engl J Med. 2010;363(21):1991-2003. Aherns R, Rodriguez S, Yen K, Davies JC. VX-770 in subjects 6 to 11 years with cystic fibrosis and the G551D-CFTR mutation [abstract]. Pediatr Pulmonol. 2011;46(suppl 34):283. Boyle MP, Bell S, Konstan MW, McColley SA, Wisseh S, Spencer-Green G. VX-809, an investigational CFTR corrector, in combination with VX-770, an investigational CFTR potentiator, in subjects with CF and homozygous for the F508del-CFTR mutation [abstract]. Pediatr Pulmonol. 2011;46(suppl 34):287. Castellani C, Cuppens H, Macek M Jr, Cassiman JJ, Kerem E, Durie P, Tullis E, Assael BM, Bombieri C, Brown A, Casals T, Claustres M, Cutting GR, Dequeker E, Dodge J, Doull I, Farrell P, Ferec C, Girodon E, Johannesson M, Kerem B, Knowles M, Munck A, Pignatti PF, Radojkovic D, Rizzotti P, Schwarz M, Stuhrmann M, Tzetis M, Zielenski J, Elborn JS. Consensus on the use and interpretation of cystic fibrosis mutation analysis in clinical practice. J Cyst Fibros. 2008 May;7(3):179-96. doi: 10.1016/j.jcf.2008.03.009. Chen Y, Luo X, Dubey N, et al. Drug-drug interaction between VX-770 and CYP3A modulators [abstract]. J Clin Pharmacol. 2011;51:1348. Drumm ML, Ziady AG, Davis PB. Genetic variation and clinical heterogeneity in cystic fibrosis. Annu Rev Pathol. 2012;7:267-282. Flume PA, Borowitz D, Liou T, et al. VX-770 in subjects with CF and homozygous for the F508del-CFTR mutation [abstract]. Pediatr Pulmonol. 2011;46(suppl 34):284-285. Kalydeco® (Ivacaftor) [package insert]. Boston, MA. Vertex Pharmaceuticals, Inc; December 2020. Available at: https://pi.vrtx.com/files/uspi_ivacaftor.pdf. Accessed on April 17, 2024. Orkambi® (lumacaftor/ivacaftor) [package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; February 2023. Available at: https://pi.vrtx.com/files/uspi_lumacaftor_ivacaftor.pdf. Accessed on April 17, 2024. McKone EF, Borowitz D, Drevinek P, et al. Long-term safety and efficacy of investigational CFTR potentiator, VX-770, in subjects with CF [abstract]. Pediatr Pulmonol. 2011;46(suppl 34):284. Mogayzel PJ Jr, Naureckas ET, Robinson KA, Mueller G, Hadjiliadis D, Hoag JB, Lubsch L, Hazle L, Sabadosa K, Marshall B; Pulmonary Clinical Practice Guidelines Committee. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013 Apr 1;187(7):680-9. National Heart, Lung, and Blood Institute. Cystic Fibrosis. Bethesda, MD. Accessed April 17, 2024. Ramsey BW, Davies J, McElvaney NG, et al; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011; 365(18):1663-1672. Robinson KA, Saldanha IJ, McKoy NA. Management of infants with cystic fibrosis: a summary of the evidence for the Cystic Fibrosis Foundation working group on care of infants with cystic fibrosis. J Pediatr. 2009;155(suppl 6): S94-S105. Simon, RH. Cystic fibrosis: Overview of the treatment of lung disease. In: UpToDate. Waltham, MA. Accessed on April 17, 2024. Symdeko® (tezacaftor/ivacaftor) [package insert]. Boston, MA. Vertex Pharmaceutical Inc.; June 2022. Available at: https://pi.vrtx.com/files/uspi_tezacaftor_ivacaftor.pdf. Accessed April 17, 2024. Trikafta™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) [package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; October 2021. Available at: https://pi.vrtx.com/files/uspi_elexacaftor_tezacaftor_ivacaftor.pdf. Accessed on April 17, 2024. Van Goor F, Hadida S, Grootenhuis PD, et al. Rescue of CF airway epithelial cell function in vitro by a CFTR potentiator, VX-770. Proc Natl Acad Sci U S A. 2009;106(44):18825-18830. Van Goor F, Yu H, Burton B, Huang T, Hoffman B, Negulescu P. VX-770 potentiation of CFTR forms with channel gating defects in vitro [abstract]. Pediatr Pulmonol. 2011;46(suppl 34):215. Woodworth BA, Zhang S, Skinner D, Sorscher EJ, Rowe SM. Comparison of CFTR and ciliary beat frequency activation by the CFTR modulators VX-770, VRT532, and UCCF-152 in primary sinonasal epithelial cultures [abstract]. Pediatr Pulmonol. 2011;46(suppl 34):251-252. Yu H, Burton B, van Goor F. VX-770, an investigational CFTR potentiator, acts on multiple CFTR forms in vitro [abstract]. Pediatr Pulmonol. 2010;45(suppl 33):318-319 | 26 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:23 AM | srv_ppsgw_P | | | Drug Name | Generic Name | | Kalydeco® | Ivacaftor | | Orkambi® | Lumacaftor/ivacaftor | | Trikafta™ | Elexacaftor/tezacaftor/ivacaftor and ivacaftor | | Symdeko® | Tezacaftor/ivacaftor |
| NA | NA | | 388 | | | 7/1/2024 | Rx.01.122 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Multiple sclerosis (MS) is the most common autoimmune, inflammatory, demyelinating disease affecting the central nervous system (CNS). An unknown stimulus causes the immune system to attack the myelin sheath that protects nerves, leading to symptoms such as weakness, numbness, vision loss, and gait disturbances. More than 2.3 million people are affected by MS worldwide. Dalfampridine (Ampyra®) is indicated to improve walking in patients with MS. Dalfampridine is a broad spectrum potassium channel blocker. The mechanism by which dalfampridine exerts its therapeutic effect has not been fully elucidated. In animal studies, dalfampridine has been shown to increase conduction of action potentials in demyelinated axons through inhibition of potassium channels.
| The intent of this policy is to communicate the medical necessity criteria dalfampridine (Ampyra®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Dalfampridine (Ampyra®) is approved when ALL the following are met: - Diagnosis of multiple sclerosis; and
- Member is 18 years of age or older; and
- Member has difficulty walking; and
- Prescribed by or in consultation with a neurologist; and
- One of the following:
- Member has an expanded disability status scale (EDSS) score less than or equal to 7; or
- Member is not restricted to using a wheelchair (if EDSS is not measured)
Initial authorization duration: 6 months CONTINUATION CRITERIA: Dalfampridine (Ampyra®) is re-approved when BOTH of the following are met: - Documentation of a 20% improvement in walking speed; and
- Prescribed by or in consultation with a neurologist
Continuation authorization duration: 2 years
|
| | | Ampyra® (dalfampridine) [package insert]. Ardsley, NY. Acorda Therapeutics, Inc. June 2022. Available from: https://ampyra.com/prescribing-information.pdf. Accessed April 17, 2024.
Olek, MJ. Mowry, E. Pathogenesis and epidemiology of multiple sclerosis. UpToDate. March 2023. Available at: https://www.uptodate.com/contents/pathogenesis-and-epidemiology-of-multiple-sclerosis. Accessed April 17, 2024.
| 15 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:23 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Ampyra | Dalfampridine |
| NA | NA | | 390 | | | 7/1/2024 | Rx.01.155 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Diclofenac epolamine 1.3% (Flector®/Licart® Patch) is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years or older.
Generic diclofenac epolamine patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults
Diclofenac sodium 1.5% and 2% solution (Pennsaid) is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Diclofenac reversibly inhibit cyclooxygenase 1 and 2 (COX-1 and COX-2) enzymes, which results in decreased formation of prostaglandin precursors. Diclofenac also has antipyretic, analgesic, and anti-inflammatory properties.
| The intent of this policy is to communicate the medical necessity criteria for diclofenac epolamine 1.3% (Flector®/Licart® Patch), diclofenac sodium 2% solution, and diclofenac sodium (Pennsaid®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: diclofenac epolamine (Flector®/Licart®) patch, diclofenac sodium 2% solution or Pennsaid® is approved when BOTH of the following are met:
- Diagnosis of pain; and
- ONE of the following:
- BOTH of the following:
- Inadequate response or inability to tolerate TWO of the following:
- Meloxicam
- Celecoxib
- Other oral NSAID; and
- Inadequate response or inability to tolerate ONE of the following:
- Generic topical diclofenac gel 1%
- Generic topical diclofenac solution 1.5%; or
- BOTH of the following:
- Member is 65 years of age or older; and
- Inadequate response or inability to tolerate ONE of the following:
- Generic topical diclofenac gel 1%
- Generic topical diclofenac solution 1.5%
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: diclofenac epolamine (Flector®/Licart®) patch, diclofenac sodium 2% solution or Pennsaid® is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
|
| Diclofenac
Cardiovascular risk: Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
GI risk: NSAIDs cause an increased risk of serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious GI events.
| | Galer BS, Rowbotham M, Perander J, et al. Topical diclofenac patch relieves minor sports injury pain: results of a multicenter controlled clinical trial. J Pain Symptom Manage. 2000 Apr;19(4):287-94.
Flector patch (diclofenac epolamine patch) [product information]. New York, NY: Pfizer, Inc. April 2021. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=829. Accessed April 17, 2024.
Licart™ (diclofenac epolamine) topical system [prescribing information]. Parsippany, NJ: IBSA Pharma Inc.: April 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=851c8b39-6056-4bbc-812e-b9b13977c1ac. Accessed April 17, 2024.
Pennsaid (diclofenac sodium topical solution) Lake Forest, IL. Horizon Pharma USA Inc. [product information]. January 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=802cd382-443d-48e3-9c9d-fd946c73c79f&type=display. Accessed April 17, 2024.
Diclofenac epolamine patch prescribing information. North Wales, PA. Teva Pharmaceuticals USA, Inc. December 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bda1c346-56ff-4197-9a19-7f0cc7f9ebad. Accessed April 17, 2024.
| 18 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:24 AM | srv_ppsgw_P | Off-Label Use Rx.01.33
Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit Rx.01.76
| | Brand Name | Generic Name | | Flector®/Licart® Patch | Diclofenac epolamine 1.3% patch | | Pennsaid® Solution | Diclofenac sodium 1.5%, 2% solution |
| Flector®/Licart® Patch, Pennsaid® | diclofenac epolamine 1.3%, diclofenac sodium 1.5%, 2% solution | | 392 | | | 7/1/2024 | Rx.01.268 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder that causes muscle weakness, disability, and eventually death, with a median survival of three to five years. The hallmark of ALS is the combination of upper motor neuron (UMN) and lower motor neuron (LMN) involvement. The LMN findings of weakness, atrophy, and fasciculations are a direct consequence of muscle denervation. The UMN findings of hyperreflexia and spasticity result from degeneration of the lateral corticospinal tracts in the spinal cord.
Edaravone is an oral suspension indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Edaravone is neuroprotective agent working in the central nervous system. Edaravone is a free radical and peroxynitrite scavenger that prevents oxidative damage to the cell membranes and may contribute to inhibiting the progression of ALD. However, the mechanism of edaravone slowing the decline of physical function in patients with ALS is unknown.
| The intent of this policy is to communicate the medical necessity criteria for Edaravone (Radicava ORS®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Edaravone (Radicava ORS®) is approved when ALL of the following are met: - Diagnosis of "definite" or "probable" amyotrophic lateral sclerosis (ALS) per the revised EL Escorial and Airlie House diagnostic criteria; and
- Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS; and
- Member has scores greater than or equal to 2 in all items of the ALS Functional Rating Scale-Revised (ALSFRS-R) criteria at the start of treatment; and
- Member has a percent (%) forced vital capacity (%FVC) greater than or equal to 80% at the start of treatment; and
- Member is not dependent on invasive ventilation or tracheostomy
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Edaravone (Radicava ORS®) is re-approved when BOTH of the following are met: - Documentation of positive clinical response to therapy (e.g., slowing in the decline of functional abilities); and
- Member is not dependent on invasive ventilation of tracheostomy
Reauthorization duration: 12 months
|
| | | Radicava ORS® (Edaravone) [package insert]. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc. Novemeber 2022. Available from: https://www.radicava.com/pdfs/radicava-prescribing-information.pdf. Accessed April 17, 2024.
Goyal NA. Disease-modifying treatment of amyotrophic lateral sclerosis. UpToDate website. Last updated April 2024. Available at: www.uptodate.com. Accessed April 17, 2024.
| 3 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:24 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Radicava ORS® | Edaravone |
| Radicava ORS® | Edaravone | | 394 | | | 7/1/2024 | Rx.01.112 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Restless legs syndrome (RLS), also known as Willis-Ekbom disease, is a condition that is characterized by a constant urge to move the legs due to uncomfortable sensations. The symptoms are usually worse during the night and are relieved temporarily by movement of the legs. The risk of RLS has been linked to other conditions such as anemia, kidney disease, multiple sclerosis, and diabetes. Treatment drug classes for RLS included dopaminergic agents, alpha-2-delta calcium channel ligands, among others.
Post herpetic neuralgia (PHN) is a complication of herpes zoster that is classified by severe pain in the areas where the rash was located, even after it has cleared. The pain usually will resolve within a few weeks or months but it can last for years in some cases, which lead to an interference with daily life.
Gabapentin is structurally related to the neurotransmitter gamma aminobutyric acid (GABA). It has no effect on GABA binding, uptake, or degradation. The exact mechanism by which gabapentin exerts its effect in restless leg syndrome (RLS) and postherpetic neuralgia (PHN) is unknown. In vitro studies show that gabapentin binds with high affinity to the alpha-2-delta subunit of voltage activated calcium channels. The relationship of this binding and gabapentin's therapeutic effect is not known. Gabapentin enacarbil is a prodrug of gabapentin.
Gabapentin (Gralise®) is indicated for the management of postherpetic neuralgia (PHN).
Gabapentin enacarbil (Horizant®) is indicated for the treatment of moderate-to-severe primary RLS and PHN in adults.
Pregabalin is structurally related to the neurotransmitter gamma aminobutyric acid (GABA). It has no effect on GABA binding, uptake, or degradation. The exact mechanism by which pregabalin exerts its effects is unknown. Pregabalin binds with high affinity to the alpha-2-delta subunit of voltage activated calcium channels in central nervous system tissues. This binding may be involved in pregabalin's antinociceptive and antiseizure effects.
Pregabalin (Lyrica CR®) is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia (PHN).
| The intent of this policy is to communicate the medical necessity criteria for gabapentin (Gralise®/Horizant®) and pregabalin (Lyrica CR®) as provided under the member's prescription drug benefit.
| Post-herpetic neuralgia
INITIAL CRITERIA: Gabapentin (Gralise®), gabapentin (Horizant®) or pregabalin (Lyrica CR®) is approved when all of the following are met: - Diagnosis of post-herpetic neuralgia, and
- Member is 18 years of age or older; and
- Inadequate response or inability to tolerate ONE of the following:
- Gabapentin; or
- Pregabalin
Initial Authorization duration: 2 years REAUTHORIZATION CRITERIA: Gabapentin (Gralise®), or gabapentin enacarbil (Horizant®), or Pregabalin (Lyrica CR®) is re-approved when there is positive clinical response to therapy.
Reauthorization duration: 2 years
__________________________________________________________________________________________________ Restless legs syndrome
INITIAL CRITERIA: Gabapentin enacarbil (Horizant®) is approved ALL of the following are met:
- Diagnosis of moderate-to-severe primary restless legs syndrome; and
- Inadequate response or inability to tolerate BOTH of the following:
- Pramipexole; and
- Ropinirole; and
- Member is 18 years of age or older
Initial Authorization duration: 2 years
REAUTHORIZATION CRITERIA Gabapentin enacarbil (Horizant®) is re-approved when there is positive clinical response to therapy.
Reauthorization duration: 2 years
___________________________________________________________________________________________________ Diabetic peripheral neuropathy
INITIAL CRITERIA: Pregabalin (Lyrica CR®) is approved when ALL of the following are met: - Diagnosis of neuropathic pain associated with diabetic peripheral neuropathy; and
- Inadequate response or inability to tolerate ONE of the following:
- Gabapentin; or
- Pregabalin; and
- Member is 18 years of age or older
Initial Authorization duration: 2 years
REAUTHORIZATION CRITERIA Pregabalin (Lyrica CR®) is re-approved when there is positive clinical response to therapy.
Reauthorization duration: 2 years
|
| | | Gabapentin. Available at: http://www.micromedexsolutions.com. Accessed April 17, 2024.
Gralise® (gabapentin) [package insert]. Newark, CA. Depomed, Inc. April 2023. Available at: https://www.gralise.com/static/Gralise_full_Prescribing_Information_-_Printed-b9a705a9011191f3f63f0a16e352cf4d.pdf . Accessed April 17, 2024.
Dopp JM, Phillips BG. Sleep–Wake Disorders. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY: McGra`w-Hill; .http://accesspharmacy.mhmedical.com.libproxy.temple.edu/content.aspx?bookid=1861§ionid=134128126. Accessed April 17, 2024.
Horizant® (gabapentin enacarbil) [package insert].Santa Clara, CA. Xenoport, Inc. August 2022. Available at: https://www.horizant.com/pdf/Horizant_PrescribingInformation.pdf . Accessed April 17, 2024.
Pregabalin. Available at: http://www.micromedexsolutions.com. Accessed April 17, 2024.
Lyrica CR® (pregabalin hydrochloride) [package insert]. New York, NY. Pfizer. December 2023. Available from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf. Accessed April 17, 2024.
Shingles (Herpes Zoster). Centers for Disease Control and Prevention. https://www.cdc.gov/shingles/about/complications.html. Published January 19, 2019. Accessed April 17, 2024.
| 16 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:24 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Gralise® | gabapentin | | Horizant® | Gabapentin enacarbil | | Lyrica CR® | pregabalin controlled-release |
| Gralise®/Horizant®, Lyrica CR® | gabapentin, pregabalin | | 395 | | | 7/1/2024 | Rx.01.269 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) is a rare, genetic, developmental epileptic encephalopathy characterized by early onset, treatment refractory seizures, motor impairments, and severe neurodevelopmental delays. CDD is estimated to affect 1 in 40,000 to 1 in 60,000 live births, with reported cases increasing as genetic testing becomes more common. The clinical severity of CDD is variable, and patients may experience one or more of several different seizure types, including infantile spasms (IS) and tonic-clonic, atonic, clonic, myoclonic, absence, and focal seizures. Patients with CDD generally respond poorly to currently approved drugs for varying seizure types, and there are currently no other approved treatments specifically for CDD.
The mechanism by which Ztalmy exerts its therapeutic effects in the treatment of seizures associated with CDD is unknown, but its anticonvulsant effects are thought to result from positive allosteric modulation in both the synaptic and extra synaptic gamma-aminobutyric acid-A (GABAA) receptors in the central nervous system (CNS), decreasing neuron excitability.
Ztalmy is indicated for the treatment of seizures associated with CDD in patients ≥ 2 years of age.
| The intent of this policy is to communicate the medical necessity criteria for Ganaxolone (Ztalmy®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Ganaxolone (Ztalmy®) is approved when ALL of the following are met: - Diagnosis of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD); and
- Documentation of mutation in the CDKL5 gene; and
- Member is experiencing motor seizures (e.g., bilateral tonic, generalized tonic-clonic, bilateral clonic, atonic, focal, or bilateral tonic-clonic); and
- One of the following:
- Inadequate response or inability to tolerate two formulary anticonvulsants (e.g., valproic acid, levetiracetam, lamotrigine); or
- Continuation of therapy with requested medication; and
- Member is 2 years of age or older; and
- Prescribed by or in consultation with a neurologist
Initial authorization duration: 6 months REAUTHORIZATION CRITERIA Ganaxolone (Ztalmy®) is re-approved when BOTH of the following are met: - Documentation of positive clinical response to therapy (e.g., reduction in frequency of major motor seizures compared to baseline); and
- Prescribed by or in consultation with a neurologist
Reauthorization duration: 2 years
|
| | | Amin S, Monaghan M, Aledo-Serrano A, et al. International Consensus recommendations for the assessment and management of individuals with CDKL5 deficiency disorder. Front Neurol. 2022;13:874695.
Food and Drug Administration (FDA). FDA approves drug for treatment of seizures associated with rare disease in patients two years of age and older [news release]. March 18, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treatment-seizures-associated-rare-disease-patients-two-years-age-and-older. Accessed April 17, 2024.
Food and Drug Administration. Ztalmy (ganaxolone) summary review. March 18, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215904Orig1s000SumR.pdf. Accessed April 17, 2024.
Jakimiec M, Paprocka J, Śmigiel R. CDKL5 deficiency disorder-a complex epileptic encephalopathy. Brain Sci. 2020;10(2):107.
Knight EMP, Amin S, Bahi-Buisson N, et al; Marigold Trial Group. Safety and efficacy of ganaxolone in patients with CDKL5 deficiency disorder: results from the double-blind phase of a randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2022;21(5):417-427.
Leonard H, Downs J, Benke TA, et al. CDKL5 deficiency disorder: clinical features, diagnosis, and management. Lancet Neurol. 2022;21(6):563-576.
Ztalmy (ganaxolone) [package insert]. Radnor, PA: Marinus Pharmaceuticals, Inc.; June 2023. Available from: https://marinuspharma.com/wp-content/uploads/2022/03/prescribing-information.pdf. Accessed April 17, 2024.
| 3 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:25 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Ztalmy® | Ganaxolone |
| Ztalmy® | Ganaxolone | | 398 | | | 7/1/2024 | Rx.01.164 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Interstitial lung diseases (ILDs) are a heterogenous group of disorders that are characterized by the inflammation and scarring of the lungs. Some ILDs have known causes and some are idiopathic. The treatment choices and prognosis vary among the different causes and types of ILDs.
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, incurable fibrotic disorder of the lower respiratory tract that typically affects adults over the age of 40. IPF is characterized by varying degrees of fibrosis, collagen deposits, and distortion of the pulmonary architecture. Although the specific initiating factor(s) leading to IPF are unknown, lung injury progresses due to the interaction of growth factors, cytokines, and other mediators, leading to fibroblast proliferation and excessive extracellular matrix deposition in the lungs. Pharmacologic treatments are limited. Prior to the FDA approval of pirfenidone (Esbriet®) and nintedanib (Ofev®) in October 2014, no medications were approved for the treatment of IPF. Traditional approaches have included various anti-inflammatory and immunosuppressive agents; however, these approaches do not seem to be effective and are no longer considered part of routine maintenance care. Early trials of agents with antifibrotic properties were disappointing. Thus, treatment has predominantly been limited to supportive care, including oxygen therapy and pulmonary rehabilitation. Lung transplantation is also an option for selected patients. Five-year survival is approximately 20-30%
Systemic Sclerosis is a rare and heterogenous autoimmune disease characterized by immune dysregulation, microvascular damage, and organ fibrosis. Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis that tends to occur early in the course of disease.
Nintedanib (Ofev®) inhibits multiple receptor tyrosine kinases and nonreceptor tyrosine kinases, including platelet-derived growth factor (PDGFR alpha and PDGFR beta), fibroblast growth factor receptor (FGFR1, FGFR2, FGFR3), vascular endothelial growth factor (VEGFR1, VEGFR2, and VEGFR3), and Fms-like tyrosine kinase-3 (FLT3). Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signaling which is crucial for the proliferation, migration, and transformation of fibroblasts. Nintedanib (Ofev®) is indicated for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis associated with Interstitial Lung Disease (SSc-ILD).
The precise mechanisms of action for pirfenidone (Esbriet®) have not been fully elucidated; however, pirfenidone may exert antifibrotic properties by decreasing fibroblast proliferation and the production of fibrosis-associated proteins and cytokines; may decrease the formation and accumulation of extracellular matrix (i.e., collagen) in response to transforming growth factor beta and platelet-derived growth factor. Pirfenidone is also believed to exert anti-inflammatory properties by decreasing the accumulation of inflammatory cells resulting from a variety of stimuli. Pirfenidone (Esbriet®) is indicated for the treatment of idiopathic pulmonary fibrosis.
Nintedanib and pirfenidone appear to slow disease progression. Neither medication is a cure for IPF.
| The intent of this policy is to communicate the medical necessity criteria for pirfenidone (Esbriet®) and nintedanib (Ofev®) as provided under the member's prescription drug benefit.
| Idiopathic Pulmonary Fibrosis (IPF)
INITIAL CRITERIA: Pirfenidone (Esbriet®) or Nintedanib (Ofev®) is approved when ALL of the following are met: - Diagnosis of Idiopathic Pulmonary Fibrosis (IPF); and
- Member is 18 years of age or older; and
- Diagnosis was confirmed by BOTH of the following:
- High resolution CT scan or biopsy; and
- Member does not have evidence or suspicion of an alternative interstitial lung disease diagnosis; and
- Prescribed by or in consultation with a pulmonologist or lung transplant specialist
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Pirfenidone (Esbriet®) or Nintedanib (Ofev®) is re-approved when there is documentation of positive clinical response to therapy (e.g., member has experienced stabilization from baseline or a less than 10% decline in forced vital capacity (FVC)) Reauthorization duration: 12 months
Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
INITIAL CRITERIA: Nintedanib (Ofev®) is approved when ALL of the following are met: - Diagnosis of Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD); and
- Member is 18 years of age or older; and
- Diagnosis was confirmed by BOTH of the following:
- High resolution CT scan or biopsy; and
- Member does not have evidence or suspicion of an alternative interstitial lung disease diagnosis; and
- Prescribed by or in consultation with a pulmonologist or lung transplant specialist
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Nintedanib (Ofev®) is re-approved when there is documentation of positive clinical response to therapy (e.g., member has experienced stabilization from baseline or a less than 10% decline in forced vital capacity (FVC)) Reauthorization duration: 12 months
Chronic Fibrosing Interstitial Lung Disease (ILDs) with a progressive phenotype
INITIAL CRITERIA: Nintedanib (Ofev®) is approved when ALL of the following are met: - Diagnosis of Chronic Fibrosing Interstitial Lung Disease (ILDs) with a progressive phenotype; and
- Member is 18 years of age or older; and
- Disease has a progressive phenotype as observed by one of the following:
- Decline of forced vital capacity (FVC); or
- Worsening of respiratory symptoms; or
- Increased extent of fibrosis seen on imaging; and
- Diagnosis was confirmed by BOTH of the following:
- High resolution CT scan or biopsy; and
- Member does not have evidence or suspicion of an alternative interstitial lung disease diagnosis; and
- Prescribed by or in consultation with a pulmonologist or lung transplant specialist
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Nintedanib (Ofev®) is re-approved when there is documentation of positive clinical response to therapy (e.g. member has experienced stabilization from baseline or a less than 10% decline in forced vital capacity (FVC)) Reauthorization duration: 12 months
| | | Esbriet® (pirfenidone) [prescribing information]. South San Francisco, CA. Genentech, Inc. February 2023. Available at: https://www.gene.com/download/pdf/esbriet_prescribing.pdf . Accessed April 17, 2024.
King TE. Treatment of idiopathic pulmonary fibrosis. UpToDate. February 2024. Available at: https://www.uptodate.com/contents/treatment-of-idiopathic-pulmonary-fibrosis?source=see_link§ionName=MEDICAL%20THERAPIES&anchor=H13191574#H13191574. Accessed April 17, 2024
Ofev® (nintedanib) [prescribing information]. Ridgefield, CT. Boehringer Ingelheim. October 2022. Available at: https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Ofev/ofev.pdf . Accessed April 17, 2024
Raghu G, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis: An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. 2015 Jul;192:e3-e19. DOI: 10.1164/rccm.201506-1063ST
| 13 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:25 AM | srv_ppsgw_P | | | Brand name | Generic name | | Ofev® | nintedanib | | Esbriet® | pirfenidone |
| Esbriet®, Ofev® | pirfenidone, nintedanib | | 400 | | | 7/1/2024 | Rx.01.248 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Cystic fibrosis is a progressive genetic condition that affects many areas of the body, including the lungs, digestive system, sweat glands and the reproductive system. Cystic fibrosis is caused by mutations in the CTFR gene, resulting in the abnormal transport of chloride and sodium ions across cell epithelia. In the respiratory system, this means there is less transport of water into the airway secretions, resulting in thick and viscous mucus accumulating in airways. These viscous secretions can obstruct the airways and promote respiratory infections, which can cause tissue damage. Common symptoms associated with cystic fibrosis include difficulty breathing, persistent productive cough and recurrent respiratory infections. Over time, these symptoms can worsen, resulting in worsening respiratory function and eventually even respiratory failure.
The precise mechanism of action of Bronchitol® in improving pulmonary function in cystic fibrosis patients is unknown.
Bronchitol® is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with Cystic Fibrosis. Use Bronchitol® only for adults who have passed the Bronchitol® Tolerance Test.
| The intent of this policy is to communicate the medical necessity criteria for Mannitol (Bronchitol®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Mannitol (Bronchitol®) is approved when all of the following are met: - Diagnosis of cystic fibrosis; and
- Member is 18 years of age or older; and
- Member has passed the Bronchitol Tolerance Test (BTT); and
- Member has inadequate response or inability to tolerate ONE of the following:
- Inhaled hypertonic saline; or
- Pulmozyme (dornase alfa); and
- Prescribed by or in consultation with one of the following:
- Pulmonologist; or
- Specialist associated with a cystic fibrosis care center
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Mannitol (Bronchitol®) is re-approved when there is documentation of positive clinical response to therapy (e.g. improvement in lung function [forced expiratory volume in one second {FEV1}])
Reauthorization duration: 2 years
|
| | | Bronchitol® (mannitol) [Package insert]. Cary, NC: Chiesi USA, Inc. October 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=454f092e-dcd0-47bd-a521-b07400403dad. Accessed April 17, 2024.
Katikin JP. Cystic fibrosis: genetics and pathogenesis. UpToDate. March 2024. Available at: https://www.uptodate.com/contents/cystic-fibrosis-genetics-and-pathogenesis. Accessed April 17, 2024
Katikin JP. Cystic fibrosis: clinical manifestations of pulmonary disease. UpToDate. February 2023. Available at: https://www.uptodate.com/contents/cystic-fibrosis-clinical-manifestations-of-pulmonary-disease. Accessed April 17, 2024
| 4 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:26 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Bronchitol® | Mannitol |
| Bronchitol® | Mannitol | | 401 | | | 7/1/2024 | Rx.01.251 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Migraine is a common primary headache disorder of unclear etiology. It is recurrent in nature and classically presents as moderate-to-severe head pain lasting 4-72 hours. Calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP) may play important roles in mediating migraine attacks.
Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors. Rizatriptan has weak affinity for other 5-HT1 receptor subtypes (5-HT1A, 5-HT1E, 5-HT1F) and the 5-HT7 receptor, but has no significant activity at 5-HT2, 5-HT3, alpha- and beta-adrenergic, dopaminergic, histaminergic, muscarinic or benzodiazepine receptors. The therapeutic activity of rizatriptan in migraine can most likely be attributed to agonist effects at 5-HT1B/1D receptors on the extracerebral, intracranial blood vessels that become dilated during a migraine attack and on nerve terminals in the trigeminal system. Activation of these receptors results in cranial vessel constriction, inhibition of neuropeptide release and reduced transmission in trigeminal pain pathways.
MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Naratriptan binds with high affinity to human cloned 5-HT1B/1D receptors. The therapeutic activity of AMERGE for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
AMERGE is indicated for the acute treatment of migraine with or without aura in adults.
Frovatriptan binds with high affinity to 5-HT1B/1D receptors. The therapeutic activity of FROVA is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
FROVA is indicated for the acute treatment of migraine with or without aura in adults.
Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine and cluster headaches through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
IMITREX injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.
ONZETRA® Xsail® is indicated for the acute treatment of migraine with or without aura in adults.
ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults.
Eletriptan binds with high affinity to 5-HT1B, 5-HT1D and 5-HT1F receptors, has modest affinity for 5-HT1A, 5-HT1E, 5-HT2B and 5-HT7 receptors. The therapeutic activity of RELPAX for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
RELPAX is indicated for the acute treatment of migraine with or without aura in adults.
Zolmitriptan binds with high affinity to human recombinant 5-HT1D and 5‑HT1B receptors, and moderate affinity for 5-HT1A receptors. The N-desmethyl metabolite also has high affinity for 5‑HT1B/1D and moderate affinity for 5‑HT1A receptors.
ZOMIG is indicated for the acute treatment of migraine with or without aura in adults.
ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
TREXIMET contains sumatriptan and naproxen. Sumatriptan binds with high affinity to cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of neuropeptide release. TREXIMET has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of TREXIMET, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
Dihydroergotamine binds with high affinity to 5-HT1Dα and 5-HT1Dβ receptors. It also binds with high affinity to serotonin 5-HT1A, 5-HT2A, and 5-HT2C receptors, noradrenaline α2A, α2B and α1 receptors, and dopamine D2L and D3 receptors. The therapeutic activity of dihydroergotamine in migraine is generally attributed to the agonist effect at 5-HT1D receptors.
D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.
MIGRANAL® and TRUDHESA™ (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.
Rimegepant is a calcitonin gene-related peptide receptor antagonist.
NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults and for the preventive treatment of episodic migraine in adults.
Ubrogepant is a calcitonin gene-related peptide receptor antagonist.
UBRELVY is indicated for the acute treatment of migraine with or without aura in adults.
Lasmiditan binds with high affinity to the 5-HT1F receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT1F receptor; however, the precise mechanism is unknown.
REYVOW® is indicated for the acute treatment of migraine with or without aura in adults.
Erenumab-aooe is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function.
AIMOVIG is indicated for the preventive treatment of migraine in adults.
Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
AJOVY is indicated for the preventive treatment of migraine in adults.
Cluster headache is an uncommon primary headache disorder characterized by attacks of severe unilateral pain with ipsilateral autonomic symptoms. Pathophysiology is unclear; proposed mechanisms involve interaction of trigeminal nerve (TN) and trigeminovascular system, parasympathetic nerve fibers (trigeminal autonomic reflex), and hypothalamus.
Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
EMGALITY is indicated for the preventive treatment of migraine in adults and for the treatment of episodic cluster headache in adults.
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.
QULIPTA is indicated for the preventive treatment of migraine in adults.
Zavegepant is a calcitonin gene-related peptide receptor antagonist.
Zavzpret™ is indicated for the acute treatment of migraine with or without aura in adults.
| The intent of this policy is to communicate the medical necessity criteria for rizatriptan (Maxalt®/Maxalt® MLT), naratriptan (Amerge®), frovatriptan (Frova®), sumatriptan (Imitrex®, Tosymra®, Onzetra® Xsail, Zembrace® Symtouch), eletriptan (Relpax®), zolmitriptan (Zomig®/ Zomig® ZMT), sumatriptan/naproxen (Treximet®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®, Trudhesa™), Rimegepant (Nurtec™ ODT), ubrogepant (Ubrelvy™), lasmiditan (Reyvow®), erenumab (Aimovig™), fremanezumab (Ajovy™), galcanezumab (Emgality™), atogepant (Qulipta™), zavegepant (Zavzpret™) as provided under the member's prescription drug benefit.
| Acute Treatment of Migraine
INITIAL CRITERIA: Frova®, Imitrex®, Tosymra®, Relpax®, Onzetra® Xsail, Zembrace® Symtouch, zolmitriptan nasal spray, or Zomig®/zolmitriptan Zomig® ZMT is approved when ALL of the following are met: - Diagnosis of migraine headache; and
- Use in the age group shown in the table below; and
- Inadequate response or inability to tolerate two generic triptans (e.g., eletriptan, naratriptan, rizatriptan, zolmitriptan, sumatriptan) as appropriate for the member's age
| Drug | Age Recommendation | | Rizatriptan | Age 6 and up | | Zolmitriptan (Zomig®/Zomig® ZMT) | Age 12 and up | | Eletriptan (Relpax®) | Age 18 and up | | Naratriptan | Age 18 and up | Sumatriptan (Imitrex®, Onzetra® Xsail, Zembrace® Symtouch, Tosymra®) | Age 18 and up | | Frovatriptan (Frova®) | Age 18 and up |
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA: Frova®, Imitrex®, Tosymra®, Relpax®, Onzetra® Xsail, Zembrace® Symtouch, zolmitriptan nasal spray or Zomig®/Zomig® ZMT is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years INITIAL CRITERIA: Sumatriptan/naproxen (Treximet®) is approved when ALL of the following are met: - Diagnosis of migraine headache; and
- Member is 12 years of age or older; and
- Inadequate response or inability to tolerate three generic triptans (e.g., eletriptan, naratriptan, rizatriptan, zolmitriptan, sumatriptan); and
- Inadequate response to concurrent administration of sumatriptan and naproxen as separate products
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Sumatriptan/naproxen (Treximet®) is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
INITIAL CRITERIA: Dihydroergotamine mesylate (D.H.E. 45®) injection is approved when ALL of the following are met:
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council of Neurologic Subspecialties; and
- Diagnosis of acute treatment of migraine or cluster headaches; and
- Member is 18 years of age or older; and
- Member has been instructed on proper preparation, injection, and disposal of medication; and
- ONE of the following:
- Inadequate response or inability to tolerate two, oral or nasal, triptans; or
- Triptan overuse, defined as using triptans greater than 8 days per month; and
- For brand D.H.E. 45 only, inadequate response or inability to tolerate generic dihydroergotamine injection or it is not available; and
- If member has 4 or more headache days per month, member must be currently treated with one of the following, unless there is a contraindication or intolerance to these medications:
- An antidepressant (i.e., Elavil [amitriptyline] or Effexor [venlafaxine])
- An anticonvulsant (i.e., Depakote/Depakote ER [divalproex sodium] or Topamax [topiramate])
- A beta-blocker (i.e., atenolol, propranolol, nadolol, timolol, or metoprolol)
- Atacand (candesartan)
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Dihydroergotamine mesylate (D.H.E 45®) injection is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
INITIAL CRITERIA: Dihydroergotamine mesylate (Migranal®) or dihydroergotamine mesylate HFA (Trudhesa™) is approved when ALL of the following are met: - Diagnosis of moderate to severe migraine headache with or without aura; and
- Inadequate response or inability to tolerate TWO, oral or nasal, triptans; and
- If member has 4 or more headache days per month, member must be currently treated with one of the following, unless there is a contraindication or intolerance to these medications:
- An antidepressant (i.e., Elavil [amitriptyline] or Effexor [venlafaxine])
- An anticonvulsant (i.e., Depakote/Depakote ER [divalproex sodium] or Topamax [topiramate])
- A beta-blocker (i.e., atenolol, propranolol, nadolol, timolol, or metoprolol)
- Atacand (candesartan); and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council of Neurologic Subspecialities
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Dihydroergotamine mesylate (Migranal®) or dihydroergotamine mesylate HFA (Trudhesa™) is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years INITIAL CRITERIA: Rimegepant (Nurtec™ ODT), ubrogepant (Ubrelvy™), zavegepant (Zavzpret) or lasmiditan (Reyvow®) is approved when all of the following are met: - Diagnosis of migraine with or without aura; and
- Will be used for the acute treatment of migraine; and
- For ubrogepant (Ubrelvy™), zavegepant (Zavzpret™), lasmiditan (Reyvow®) only, will not be used for preventative treatment of migraine; and
- Member is 18 years of age or older; and
- Inadequate response or inability to tolerate two triptans (e.g., eletriptan, rizatriptan, sumatriptan); and
- If the member has 4 or more headache days per month, the member must be on current treatment or have inability to tolerate one of the following:
- Elavil (amitriptyline) or Effexor (venlafaxine); or
- Depakote/Depakote ER (divalproex sodium) or Topamax (topiramate); or
- Beta blocker (i.e., atenolol, propranolol, nadolol, timolol, or metoprolol); or
- Atacand (candesartan); and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council of Neurologic Subspecialties; and
- Medication will not be used in combination with another CGRP antagonist for the acute treatment of migraines; and
- For Lasmiditan (Reyvow®) and zavegepant (Zavzpret) only, inadequate response or inability to tolerate BOTH rimegepant (Nurtec™ ODT) and ubrogepant (Ubrelvy™)
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Rimegepant (Nurtec™ ODT), ubrogepant (Ubrelvy™), zavegepant (Zavzpret) or lasmiditan (Reyvow®) is reapproved when all of the following are met: - Member has experienced a positive response to therapy (e.g., reduction in pain, photophobia, phonophobia, nausea); and
- For ubrogepant (Ubrelvy™), zavegepant (Zavzpret™), lasmiditan (Reyvow®) only, will not be used for preventative treatment of migraine; and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council of Neurologic Subspecialties; and
- Medication will not be used in combination with another CGRP antagonist for the acute treatment of migraines
Reauthorization duration: 2 years
Preventative Treatment of Episodic or Chronic Migraine with Injectable CGRP Antagonists
INITIAL CRITERIA: Erenumab (Aimovig™), fremanezumab (Ajovy™), or galcanezumab (Emgality™) 120mg/ml is approved when ALL of the following are met: - Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council for Neurologic Subspecialties, and
- Member is 18 years of age or older; and
- ONE of the following:
- Diagnosis of episodic migraines defined as 4-14 headache days per month and inadequate response or inability to tolerate at least a two-month trial of TWO of the following prophylactic medications:
- Topiramate
- Divalproex sodium/ valproic acid
- Beta-blocker: metoprolol, propranolol, timolol, atenolol, nadolol
- Tricyclic antidepressants: amitriptyline, nortriptyline
- SNRI antidepressants: venlafaxine, duloxetine; or
- Candesartan (Atacand); or
- Diagnosis of chronic migraines defined as 15 or more headache days per month and inadequate response or inability to tolerate at least a two-month trial of TWO of the following prophylactic medications:
- Topiramate
- Divalproex sodium/valproic acid
- Beta-blocker: metoprolol, propranolol, timolol, atenolol, nadolol
- Tricyclic antidepressants: amitriptyline, nortriptyline
- SNRI antidepressants: venlafaxine, duloxetine; or
- Trial of additional prophylactic medications does not apply if member has previously been treated with Onabotuliniumtoxin A (Botox) for migraines; and
- Medication overuse headache has been considered and potentially offending medication(s) have been discontinued; and
- Medication will not be used in combination with another CGRP inhibitor for the preventive treatment of migraines; and
- For galcanezumab (Emgality™ 120mg/ml) only, inadequate response or inability to tolerate BOTH erenumab (Aimovig™) and fremanezumab (Ajovy™).
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: Erenumab (Aimovig™), fremanezumab (Ajovy™), or galcanezuma (Emgality™) 120mg/ml is re-approved when ALL of the following are met: - Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council for Neurologic Subspecialties, and
- Documentation of response to therapy as defined by 50% reduction in headache days per month from baseline (defined as at least 4 hours duration and moderate intensity); and
- For galcanezumab (Emgality™ 120mg/ml) only, inadequate response or inability to tolerate BOTH erenumab (Aimovig™) and fremanezumab (Ajovy™); and
- Use of acute migraine medication (e.g., nonsteroidal anti-inflammatory drugs (NSAID) (e.g., ibuprofen, naproxen), triptans (e.g., eletriptan, rizatriptan, sumatriptan) has decreased since the start of CGRP therapy; and
- For Chronic migraine only: member continues to be monitored for medication overuse headache (MOH); and
- Medication will not be used in combination with another CGRP inhibitor for the preventive treatment of migraines
Reauthorization duration: 12 months Preventative Treatment of Episodic Migraines with Oral CGRP Antagonist
INITIAL CRITERIA: Rimegepant (Nurtec™ ODT) or atogepant (Qulipta™) is approved when all of the following are met: - Both of the following:
- Diagnosis of episodic migraines; and
- One of the following:
- For Nurtec ODT only, member has 4 to 18 migraine days per month, but no more than 18 headache days per month; or
- For Qulipta only, Member has 4 to 14 migraine days per month, but no more than 14 headache days per month; and
- Member is 18 years of age or older; and
- Two of the following:
- Inadequate response or inability to tolerate at least a two-month trial of Elavil (amitriptyline) or Effexor (venlafaxine); or
- Inadequate response or inability to tolerate at least a two-month trial of Depakote/Depakote ER (divalproex sodium) or Topamax (topiramate); or
- Inadequate response or inability to tolerate at least a two-month trial of one of the following beta blockers: atenolol, propranolol, nadolol, timolol, or metoprolol; and
- Inadequate response or inability to tolerate at least a two-month trial of Atacand (candesartan); and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council for Neurologic Subspecialties; and
- Medication will not be used in combination with another CGRP antagonist for the preventative treatment of migraines
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: Rimegepant (Nurtec™ ODT) or atogepant (Qulipta™) is re-approved when all of the following are met: - Member has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity; and
- Use of acute migraine medications [e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen), triptans (e.g., eletriptan, rizatriptan, sumatriptan)] has decreased since the start of CGRP therapy; and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council for Neurologic Subspecialties; and
- Medication will not be used in combination with another CGRP antagonist for the preventative treatment of migraines
Reauthorization duration: 2 years Preventive treatment of Chronic Migraine with Oral CGRP Antagonist
INITIAL CRITERIA: Atogepant (Qulipta™) is approved when all of the following are met: - Diagnosis of chronic migraines defined as 15 or more headache days per month, of which at least 8 must be migraine days for at least 3 months; and
- Inadequate response or inability to tolerate at least two-month trial of TWO of the following prophylactic medications:
- Tricyclic antidepressants: amitriptyline, nortriptyline
- Topiramate
- Divalproex sodium/valproic acid
- Beta blocker: metoprolol, propranolol, timolol, atenolol, nadolol
- SNRI antidepressants; venlafaxine, duloxetine
- Candesartan (Atacand)
- Trial of additional prophylactic medications does not apply if member has previously been treated with Onabotuliniumtoxin A (Botox) for migraines; and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council for Neurologic Subspecialties; and
- Member is 18 years of age or older; and
- Medication will not be used in combination with another CGRP inhibitor for the preventative treatment of migraines; and
- Medication overuse headache has been considered and potentially offending medication(s) have been discontinued
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: Atogepant (Qulipta™) is re-approved when all of the following are met: - Member has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity; and
- Use of acute migraine medications [e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen), triptans (e.g., eletriptan, rizatriptan, sumatriptan)] has decreased since the start of CGRP therapy; and
- Member continues to be monitored for medication overuse headache (MOH); and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by the United Council for Neurologic Subspecialties; and
- Medication will not be used in combination with another CGRP inhibitor for the preventative treatment of migraines
Reauthorization duration: 2 years
Episodic Cluster Headaches
INITIAL CRITERIA: Galcanezumab (Emgality™) 100mg/ml is approved when ALL of the following are met: - Diagnosis of episodic cluster headache; and
- Member has experienced at least 2 cluster periods lasting 7 days to 365 days, separated by pain-free periods lasting at least three months; and
- Member is 18 years of age or older; and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by united council for neurologic subspecialties, or pain specialist; and
- Medication will not be used in combination with another CGRP antagonist
Initial authorization duration: 3 months
REAUTHORIZATION CRITERIA: Galcanezumab (Emgality™) 100mg/ml is re-approved when ALL of the following are met: - Member has experienced a positive clinical response to therapy, demonstrated by a reduction in headache frequency and/or intensity; and
- Prescribed by or in consultation with one of the following specialists:
- Neurologist; or
- Pain specialist; or
- Headache specialist certified by united council for neurologic subspecialties, or pain specialist; and
- Medication will not be used in combination with another CGRP antagonist
Reauthorization duration: 12 months
| Migranal®, D.H.E 45®, Trudhesa™ WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of TRUDHESA with strong CYP3A4 inhibitors is contraindicated. Treximet® WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. TREXIMET is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
| | DynaMed [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - . Record No. T114718, Migraine in Adults; [updated 2018 Nov 30, cited 2022 April 01]. Available from https://www.dynamed.com/topics/dmp~AN~T114718. MAXALT, MAXALT-MLT (rizatriptan) [package insert]. Kenilworth, NJ: GlaxoSmithKline. September 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d93286f5-99f7-4dc5-aa9d-ad73ab8490db. Accessed April 17, 2024. Amerge (naratriptan) [package insert]. Research Triangle Park, NC: GlaxoSmithKline. October 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=13f4a8ec-75a3-4c51-b3bc-6244f3c79e95&type=display. Accessed April 17, 2024. Frova (frovatriptan) [package insert]. Dublin, IE: Endo Pharmaceuticals, Inc.. August 2018. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c0703630-9ce8-4259-841e-71fd2019fa66. Accessed April 17, 2024. Imitrex (sumatriptan) [package insert]. Research Triangle Park, NC: GlaxoSmithKline. December 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584abe73-8290-4484-ff8e-5890831c095e. Accessed April 17, 2024. Tsoymra (sumatriptan) [package insert]. Bridgewater, NJ: Promius Pharma, LLC. January 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7260d567-3824-230d-836d-8065302baaec. Accessed April 17, 2024. Onztra Xsail (sumatriptan) [package insert]. Morristown, NJ: Currax Pharmaceuticals LLC. July 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a8a9889e-69b9-4a57-b8c0-d40b1025c559. Accessed April 17, 2024. Zembrace SymTouch (sumatriptan) [package insert]. Bridgewater, NJ: Promius Pharma, LLC. June 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d565763d-b740-411d-bbb4-13536017d634. Accessed April 17, 2024. Relpax (eletriptan) [package insert]. Hoffman Estates, IL: Roerig. July 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=85745375-fcb6-4edc-b6db-a77b4a5f3e8c. Accessed April 17, 2024. Zomig, Zomig-ZMT (zolmitriptan) [package insert]. Bridgewater Township, NJ: Amneal Pharmaceuticals. May 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df93b636-103f-4fb5-26b6-50f639e29b1d. Accessed April 17, 2024. Treximet (sumatriptan succinate and naproxen sodium) [package insert]. Morristown, NJ: Currax Pharmaceuticals LLC. May 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=42ddf376-8dc0-4236-be2a-0c6ae92ece04. Accessed April 17, 2024. D.H.E 45 (dihydroergotamine mesylate) [package insert]. Bridgewater Township, NJ: Bausch Health US, LLC. May 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe826e6a-75c8-43ed-9c36-f8263ec35aff. Accessed April 17, 2024. Migranal (dihydroergotamine mesylate) [package insert]. Bridgewater Township, NJ: Bausch Health US, LLC. July 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a24befa8-b952-48ac-942a-379585250782. Accessed April 17, 2024. Nurtec ODT (rimegepant) [package insert]. New Haven, CT: Biohaven Pharmaceuticals, Inc. June 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ef08e09-1098-35cc-e053-2a95a90a3e1d. Accessed April 17, 2024. Ubrelvy (ubrogepant) [package insert]. Irvine, CA: Allergan, Inc. March 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd9f9458-fd96-4688-be3f-f77b3d1af6ab. Accessed April 17, 2024. Reyvow (lasmiditan) [package insert]. Indianapolis, IN: Eli Lilly and Company. April 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aea3358c-ff41-4490-9e6d-c7bf7b3de13f. Accessed April 17, 2024. Aimovig (erenumab-aooe) [package insert]. Thousand Oaks, CA: Amgen Inc. May 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8. Accessed April 17, 2024. Ajovy (fremanezumab-vfrm) [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc. June 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e344ea-5916-4947-b6f2-4a76ccc04b6b. Accessed April 17, 2024. DynaMed [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - . Record No. T116292, Cluster Headache; [updated 2018 Nov 30, cited 2022 April 01]. Available from https://www.dynamed.com/topics/dmp~AN~T116292. Emgality (galcanezumab-gnlm) [package insert]. Indianapolis, IN: Eli Lilly and Company. September 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33a147be-233a-40e8-a55e-e40936e28db0 Accessed April 17, 2024. Qulipta™ (atogepant) [package insert]. Dublin, Ireland: AbbVie. June 2023. Available at: https://www.rxabbvie.com/pdf/QULIPTA_pi.pdf. Accessed April 17, 2024. Trudhesa™ (dihydroergotamine mesylate nasal spray) [package insert]. Seattle, WA: Impel NeuroPharma Inc. September 2021. Available from: https://www.trudhesa.com/trudhesa-prescribing-information.pdf. Accessed April 17, 2024.
Zavzpret™ (zavegepant) [package insert]. New York, NY: Pfizer Inc. March 2023. Available from: https://labeling.pfizer.com/ShowLabeling.aspx?id=19471. Accessed April 17, 2024
| 6 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:26 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Maxalt®/Maxalt® MLT | Rizatriptan | | Amerge® | Naratriptan | | Frova® | Frovatriptan | | Imitrex®, Tosymra®, Onzetra® Xsail, Zembrace® Symtouch | Sumatriptan | | Relpax® | Eletriptan | | Zomig®/ Zomig® ZMT | Zolmitriptan | | Treximet® | Sumatriptan/naproxen | | D.H.E. 45®, Migranal®, Trudhesa™ | Dihydroergotamine mesylate | | Nurtec™ ODT | Rimegepant | | Ubrelvy™ | Ubrogepant | | Reyvow® | Lasmiditan | | Aimovig™ | Erenumab | | Ajovy™ | Fremanezumab | | Emgality™ | Galcanezumab | | Qulipta™ | Atogepant | | Zavzpret™ | zavegepant |
| Maxalt®/Maxalt® MLT, Amerge®, Frova®, Imitrex®, Tosymra®, Onzetra® Xsail, Zembrace® Symtouch, Relpax®, Zomig®/ Zomig® ZMT, Treximet®, D.H.E. 45®, Migranal®, Trudhesa™, Nurtec™ ODT, Ubrelvy™, Reyvow®, Aimovig™, Ajovy™, Emgality™, Qulipta™, Zavzpret™ | rizatriptan, naratriptan, frovatriptan, sumatriptan, eletriptan, zolmitriptan, sumatriptan/naproxen, dihydroergotamine mesylate, rimegepant, ubrogepant, lasmiditan, erenumab, fremanezumab, galcanezumab, atogepant, zavegepant | | 403 | | | 7/1/2024 | Rx.01.278 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Friedreich’s ataxia is a progressive neurodegenerative disorder that causes progressive damage to the central nervous system. This is a rare disease that is caused by a mutation in the Frataxin (FXN) gene. A mutation in this gene causes mitochondrial dysfunction which causes iron accumulation and generation of a reactive oxygen species. In doing so, oxidative stress builds up in the body and causes cell damage. Symptoms of Friedreich’s ataxia include: trouble walking, tiredness, loss of reflexes, slow/slurred speech, hearing loss, loss of sensation, and shortness of breath.
Omaveloxolone belongs to a therapeutic drug class known as Nrf2 Pathway Activators which are known to reduce oxidative stress. In patients that have ataxia, Nrf2 levels are lower than normal. By taking omaveloxolone the Nrf2 translocates to the nucleus which in turn lowers oxidative stress in patients. Oxidative stress plays a role in several conditions in the body including neurodegenerative diseases. Thus, by lowering oxidative stress, symptoms associated with Freidrich’s ataxia can be reduced.
Skyclarys® is indicated for Freidrich’s ataxia in adults and adolescents aged 16 and older.
| The intent of this policy is to communicate the medical necessity criteria for Omaveloxolone (Skyclarys®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Omaveloxolone (Skyclarys®) is approved when all of the following are met: - Diagnosis of Friedreich ataxia as confirmed via genetic testing demonstrating mutation in FXN gene; and
- Member has a Modified Friedreich's Ataxia Rating Scale (mFARS) score of greater than or equal to 20 and less than or equal to 80; and
- Member has B-type natriuretic peptide value less than or equal to 200 pg/ml; and
- Member is 16 years of age or older; and
- Prescribed by or in consultation with one of the following:
- Neurologist; or
- Neurogeneticist; or
- Physiatrist (Physical Medicine and Rehabilitation Specialist)
Initial authorization duration: 1 year
CONTINUATION CRITERIA: Omaveloxolone (Skyclarys®) is re-approved when BOTH of the following are met: - Documentation of positive clinical response to therapy as evidenced by one of the following:
- A decrease in the rate of progression of Modified FA rating scale (mFARS) score; or
- An increase in peak work (in Watts/kg) during exercise testing from baseline; and
- Prescribed by or in consultation with one of the following:
- Neurologist; or
- Neurogeneticist; or
- Physiatrist (Physical Medicine and Rehabilitation Specialist)
Reauthorization duration: 1 year
|
| | | Skyclarys (omaveloxolone) [package insert]. Plano, TX; Reata Pharmaceuticals. January 2024. Available from: https://www.skyclarys.com/docs/skyclarys_us_prescribing_information/. Accessed April 17, 2024.
Opal P. Friedreich ataxia. UpToDate. December 2023. Available at: https://www.uptodate.com. Accessed April 17, 2024. Pizzino G, Irrera N, Cucinotta M, et al. Oxidative stress: Harms and benefits for human health. Oxidative medicine and cellular longevity. 2017. Accessed August 3, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5551541/.
| 2 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:26 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Skyclarys® | Omaveloxolone |
| Skyclarys® | Omaveloxolone | | 404 | | | 7/1/2024 | Rx.01.243 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Spinal muscular atrophy (SMA) is characterized by degeneration of the anterior horn cells in the spinal cord and motor nuclei in the lower brainstem, which results in progressive muscle weakness and atrophy. The diagnosis of SMA should be suspected for any infant with unexplained weakness or hypotonia. Additional clues suggesting the diagnosis in infants, children, or adults include a history of motor difficulties, loss of motor skills, proximal muscle weakness, hyporeflexia or areflexia, tongue fasciculations, and signs of lower motor neuron disease on examination. These diseases classified as types 0 through 4, depending upon the age of onset and clinical course.
Risdiplam is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat patients with spinal muscular atrophy (SMA) caused by mutations in chromosome 5q that lead to SMN protein deficiency. Using in vitro assays and studies in transgenic animal models of SMA, risdiplam was shown to increase exon 7 inclusion in SMN2 messenger ribonucleic acid (mRNA) transcripts and production of full-length SMN protein in the brain. In vitro and in vivo data indicate that risdiplam may cause alternative splicing of additional genes, including FOXM1 and MADD. FOXM1 and MADD are thought to be involved in cell cycle regulation and apoptosis, respectively, and have been identified as possible contributors to adverse effects seen in animals.
Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
| The intent of this policy is to communicate the medical necessity criteria for Risdiplam (Evrysdi®) as provided under the member's prescription drug benefit.
| INITAL CRITERIA: Risdiplam (Evrysdi™) is approved when ALL of the following are met: - Diagnosis of spinal muscular atrophy (SMA) type 1, 2 or 3; and
- BOTH of the following:
- The mutation or deletion of genes in chromosome 5q resulting in one of the following:
- Homozygous gene deletion or mutation (e.g., homozygous deletion of exon 7 at locus 5q13); or
- Compound heterozygous mutation (e.g., deletion of SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2]); and
- Member has at least 2 copies of SMN2; and
- Prescribed by or in consultation with a neurologist or a psychiatrist with subspecialty certification in neuromuscular medicine; and
- Member is not to receive concomitant chronic survival motor neuron (SMN) modifying therapy for the treatment of SMA (e.g., Spinraza)
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Risdiplam (Evrysdi™) is re-approved when ALL of the following are met: - Documentation of positive clinical response to therapy from pretreatment baseline status; and
- Prescribed by or in consultation with a neurologist or a psychiatrist with subspecialty certification in neuromuscular medicine; and
- Member is not to receive concomitant chronic survivor motor neuron (SMN) modifying therapy for the treatment of SMA (e.g., Spinraza)
Reauthorization duration: 2 years
|
| | | Evrysdi™ (risdiplam) [prescribing information]. San Francisco, CA: Genentech, Inc; February 2024. Available from: https://www.gene.com/download/pdf/evrysdi_prescribing.pdf. Accessed April 17, 2024. Bodamer, OA. Spinal muscular atrophy. In: UpToDate. July 2023. Available from: www.uptodate.com. Accessed April 17, 2024.
Day JW, Annoussamy M, Baranello G, et al. SUNFISH Part 2: 24-month efficacy outcomes of risdiplam (RG7916) treatment in patients with Type 2 or 3 spinal muscular atrophy (SMA). Presented at the 2020 Virtual SMA Research & Clinical Care Meeting. Servais L, Baranello G, Masson R, et al. FIREFISH Part 2: Efficacy and safety of risdiplam (RG7916) in infants with Type 1 spinal muscular atrophy (SMA). Presented at the 2020 Virtual SMA Research & Clinical Care Meeting. Markowitz JA, Sing P, Darras BT. Spinal muscular atrophy: a clinical and research update. Pediatr Neurol. 2012;46(1):1-12. Wang CH, Finkel RS, Bertini ES, et al. Consensus statement for standard of care in spinal muscular atrophy. J Child Neurol. 2007;22(8):1027-1049. Bertini E DJ, Muhaizea A, et al. RAINBOWFISH: A Study of Risdiplam (RG7916) in Newborns with Presymptomatic Spinal Muscular Atrophy. Presented at: World Muscle Society; October 1–5, 2019; Copenhagen, Denmark. Mercuri E, Finkel RS, Muntoni F, et al. Diagnosis and management of spinal muscular atrophy: Part 1: Recommendations for diagnosis, rehabilitation, orthopedic and nutritional care. J Neuromuscul Dis. 2018;28(2):103-115. Page 723 Stolte B, Bois JM, Kizina K, et al. Minimal clinically important differences in functional motor scores in adults with spinal muscular atrophy. Eur. J. Neurol. 2020; 0:1-9. Pera, M., Coratti, G., Mazzone, E., et al. (2019). Revised upper limb module for spinal muscular atrophy: 12 month changes. Muscle Nerve. Apr;59(4):426-430. Kirschner J, Butoianu N, Goemans N, et al. European ad-hoc consensus statement on gene replacement therapy for spinal muscular atrophy. Eur J Paediatr Neurol. 2020. https://doi.org/10.1016/j.ejpn.2020.07.001
| 5 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:26 AM | srv_ppsgw_P | | | Brand Name | Generic Name | Evrysdi™
| Risdiplam |
| Evrysdi™ | Risdiplam | | 405 | | | 7/1/2024 | Rx.01.237 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Neuromyelitis optica spectrum disorders (NMOSD), are inflammatory disorders of the central nervous system characterized by severe, immune-mediated demyelination and axonal damage predominantly targeting optic nerves and spinal cord. NMOSD can be distinguished from multiple sclerosis and other central nervous system inflammatory disorders by the unique presence of the disease-specific aquaporin-4 (AQP4) antibody, which plays a direct role in the pathogenesis of NMOSD.
Common features of NMOSD include acute attacks characterized by bilateral or rapidly sequential optic neuritis (leading to visual loss), acute transverse myelitis (often causing limb weakness and bladder dysfunction), and the area postrema syndrome (with intractable hiccups or nausea and vomiting).
The precise mechanism by which Satralizumab-mwge (Enspryng™) exerts therapeutic effects in NMOSD is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors. Satralizumab-mwge (Enspryng™) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
| The intent of this policy is to communicate the medical necessity criteria for Satralizumab-mwge (Enspryng™) as provided under the member's prescription drug benefit.
| INITAL CRITERIA: Satralizumab-mwge (Enspryng™) is approved when ALL of the following are met: - Diagnosis of neuromyelitis optica spectrum disorder (NMOSD); and
- Member is anti-aquaporin-4 (AQP4) antibody positive; and
- Prescribed by or in consultation with a neurologist or ophthalmologist; and
- Member is 18 years of age or older
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Satralizumab-mwge (Enspryng™) is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
| | | Enspryng™ (satralizumab-mwge) [prescribing information]. San Francisco, CA: Genentech, Inc; March 2022. Available from: https://www.gene.com/download/pdf/enspryng_prescribing.pdf. Accessed April 17, 2024.
Glisson C. Neuromyelitis optica spectrum disorders. UpToDate website. Last updated August 2022. Available at: www.uptodate.com. Accessed April 17, 2024.
| 4 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:26 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Enspryng™ | Satralizumab-mwge |
| Enspryng™ | Satralizumab-mwge | | 407 | | | 7/1/2024 | Rx.01.271 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Human papillomavirus (HPV) is a common cause of cutaneous and mucosal infection. Condylomata acuminata (CA; singular: condyloma acuminatum), also known as anogenital warts, are manifestations of HPV infection that occur in a subset of individuals with anogenital HPV infection. External CA typically manifest as soft papules or plaques on the external genitalia, perianal skin, perineum, or groin. For most patients, the presence of genital warts is concerning because of their cosmetic appearance, association with a sexually transmitted disease, bothersome symptoms, absence of a cure, and social stigma. Although treatment can eradicate the warts, disease recurrence is common and occurs in 20 to 30 percent of patients overall.
The mode of action of Veregen involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown. Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
| The intent of this policy is to communicate the medical necessity criteria for Sinecatechins (Veregen®) as provided under the member's prescription drug benefit.
| Sinecatechins (Veregen®) is approved when all of the following are met:
- Diagnosis of Condylomata acuminata (external genital and perianal warts); and
- Member is immunocompetent; and
- Member is 18 years of age or older; and
- Inadequate response or inability to tolerate imiquimod (generic Aldara®)
Authorization duration: 4 months
Total duration of treatment is limited to 16 weeks per lifetime
| | | Rosen T. Condylomata acuminata (anogenital warts) in adults: Epidemiology, pathogenesis, clinical features, and diagnosis. In: Post T, ed. UpToDate. December 2022. www.uptate.com. Accessed April 17, 2024..
Veregen® (Sinecatechins) [prescribing information]. Melville, New York: PharmaDerm®; February 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c1cd745-79ab-487d-b759-995794cedb92. Accessed April 17, 2024.
| 3 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:27 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Veregen® | Sinecatechins |
| Veregen® | sinecatechins | | 408 | | | 7/1/2024 | Rx.01.274 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Tuberous sclerosis complex (TSC) is an inherited neurocutaneous disorder that involve many organ systems, including developmental delay and multiple benign hamartomas of the brain, eyes, heart, lung, liver, kidney, and skin. The expression of the disease varies substantially among individuals and within families. Some individuals with TSC may demonstrate only dermatologic features of the disease while others may develop more serious neurologic or systemic manifestations. Nearly all patients with TSC have one or more of the skin lesions characteristic of the disorder.
The mechanism of action of sirolimus in the treatment of angiofibroma associated with tuberous sclerosis is unknown. Tuberous sclerosis is associated with genetic defects in TSC1 and TSC2 which leads to the constitutive activation of mammalian target of rapamycin (mTOR). Sirolimus inhibits mTOR activation.
Hyftor™ is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.
| The intent of this policy is to communicate the medical necessity criteria for Sirolimus topical gel (Hyftor™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Sirolimus (Hyftor™) is approved when ALL of the following are met: - Diagnosis of facial angiofibroma associated with tuberous sclerosis complex; and
- Member is 6 years of age or older; and
- Member is not a candidate for laser therapy or surgical treatments; and
- Prescribed by or in consultation with a dermatologist, neurologist, or geneticist
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: Sirolimus (Hyftor™) is re-approved with documentation of positive clinical response to therapy (e.g., improvement in size or redness of facial angiofibroma)
Reauthorization duration: 2 years
|
| | | Randle S. Tuberous sclerosis complex: Management and prognosis. UpToDate. February 2024. Available from: uptodate.com. Accessed April 17, 2024. HyftorTM (sirolimus) [package insert]. Bethesda, MD: Nobelpharma America, LLC; March 2022. Available at https://www.hyftor.com/wp-content/uploads/2022/04/Approved-PI.pdf. Accessed April 17, 2024.
| 2 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:27 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Hyftor™ | sirolimus |
| Hyftor™ | Sirolimus | | 409 | | | 7/1/2024 | Rx.01.222 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neuropsychiatric disorders of childhood and adolescences where symptoms often persist into adulthood. It is associated with significant impairment in occupational, academic, and social functioning. ADHD in adults is characterized by symptoms of inattention, impulsiveness, restlessness, executive dysfunction, and emotional dysregulation. Compared to adults with ADHD, symptoms of inattention, hyperactivity and impulsive behaviors are more prominent in children and adolescents. Prescription stimulants are an integral part of treatment for attention deficit hyperactivity disorder (ADHD) but it is also one of the most frequently abused prescription drugs in the United States. In 2016, an estimated 5,647,000, or 2.1% of persons aged 12 and older, reported misuse of prescription stimulants in the past year. In 2017, a total of 10,333 deaths involving psychostimulants occurred, representing 14.7% of drug overdose deaths and a 37.0% increase from 2016 per the CDC. The cumulative dose limit is based on the cumulative daily dose of drugs with the same active ingredient. Prior authorization is required when the request exceeds the recommended dose for medications with that active ingredient outlined below: High cumulative daily dose limit - This limit is in place to ensure alternative medications have been reviewed and potential adverse effects have been accessed. | Active ingredient | Medications impacted (brands and generics) | High cumulative daily dose | | Amphetamine | Adzenys® [XR ODT/ER] Dyanavel® [XR] Evekeo® [ODT] | 60mg/day | Amphetamine/ Dextroamphetamine | Adderall® [IR/XR] Mydayis®
| 60mg/day | | Dextroamphetamine | Dexedrine® Zenzedi® ProCentra® Xelstrym™ | 60mg/day | | Lisdexamfetamine | Vyvanse® | 70mg/day | | Methamphetamine | Desoxyn® | 60 mg/day | | Dexmethylphenidate | Focalin® [IR/XR] | 40mg/day | | Methylphenidate | Ritalin® [IR/LA] Daytrana® Cotempla® Metadate® [ER/CD] Methylin® Quillivant® XR Concerta® Aptensio® XR QuilliChew® ER Adhansia® XR Jornay PM™ Methylphenidate (Relexxii®) | 72mg/day | | Serdexmethylphenidate | Azstarys™ | 52.3 mg/day |
| The intent of this policy is to communicate the medical necessity criteria for prescription stimulants under the member's prescription benefit when the cumulative dose of an active ingredient exceeds the limit set by the plan.
| Doses above the high cumulative dose are approved when ALL of the following are met: - Inadequate response or inability to tolerate an alternative active ingredient within the CNS stimulant drug class prior to increasing the dose beyond the cumulative high dose limit; and
- Member has been assessed for, and counseled by prescriber on ALL of the following:
- The risk for substance abuse; and
- The risk for cardiac related adverse events (i.e., hypertension); and
- The risk for new or worsening psychosis (i.e., maniac behavior); and
- Requests that exceed the cumulative daily dose for the total daily dose of the drug, dose frequency, or duration of therapy approved or recommended by the FDA or as stated in accepted compendia are considered off-label and are reviewed per Off-Label Use policy
Authorization duration: 12 months
INITIAL CRITERIA: Amphetamine (Evekeo®) is approved when ONE of the following is met:
- Diagnosis of narcolepsy and ALL of the following:
- Recommended by a neurologist or sleep specialist; and
- Inadequate response or inability to tolerate generic modafinil or armodafinil; and
- Diagnosis confirmed by ONE of the following tests:
- Polysomnography (PSG); or
- Multiple sleep latency test (MSLT); or
- Attention Deficit Disorder with Hyperactivity (ADHD) with inadequate response or inability to tolerate TWO of the following generic stimulant agents for ADHD:
- Methylphenidate
- Mixed amphetamine salts
- Dextroamphetamine
- Methamphetamine hydrochloride
- Dexmethylphenidate; or
- Exogenous Obesity:
- If member has weight loss rider please refer to Weight Loss Agents policy for approval criteria and duration; or
- If member does not have a weight loss agents rider; deny as benefit exclusion*
*Drugs that are used for weight loss are covered only with weight loss rider.
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Amphetamine (Evekeo®) is re-approved when there is documentation of positive clinical response.
Reauthorization duration: 2 years
Quantity limit requests are approved when ONE of the following is met: (drug specific criteria below). - Requests that exceed the cumulative daily dose, dose frequency, or duration of therapy approved or recommended by the FDA or as stated in accepted compendia1 are considered off-label and are reviewed per Off-Label Use policy, or
- Requests that do not exceed the cumulative daily dose, dose frequency or duration of therapy approved or recommended by the FDA or as stated in accepted compendia1: A quantity limit exceeding those listed in the following table is approved when ONE of the following is met:
- Documentation of the inability to reach the requested dose with higher strengths of commercially available dosage forms due to member specific characteristics (i.e., inability to swallow larger pills, malabsorption, presence of a feeding tube, etc.); or
- The requested dose is not commercially available; or
- The requested dose is used for titration or loading-dose purposes (one-time authorization)
1 Please refer to the Off-Label Use policy for definition of accepted compendia
Authorization duration: 2 years
Authorization duration for dose titration: 14 days | Medication | Maximum Quantity per day | Quantity limit per rolling 30 days, unless otherwise specified (tablets, capsules, mL) | | Amphetamine (Adzenys XR®) | 1 | 30 | | Amphetamine (Adzenys ER®) 1.25mg/ml susp | 15 ml | 450 | | Dextroamphetamine/Amphetamine (Adderall®) 5mg, 7.5mg, 10mg, 12.5mg, 15mg and 20mg | 3 | 90 | | Dextroamphetamine/Amphetamine (Adderall®) 30mg | 2 | 60 | | Amphetamine/Dextroamphetamine ER (Mydayis™) | 1 | 30 | | Dextroamphetamine/Amphetamine (Adderall XR®) 5mg, 10mg, 15mg, 20mg, 25mg, 30mg | 1 | 30 | | Amphetamine (Dyanavel XR®) 2.5mg/ml Susp | 8mL | 240 | | Amphetamine (Dyanavel XR®) 5mg, 10mg, 15mg, 20mg tablets | 1 | 30 | | Dextroamphetamine sulfate (Dexedrine®) 5mg cap SA | 3 | 90 | | Dextroamphetamine sulfate (Dexedrine®) 10mg cap SA | 6 | 180 | | Dextroamphetamine sulfate (Dexedrine®) 15mg cap SA | 4 | 120 | | Dextroamphetamine sulfate 5mg tablet | 3 | 90 | | Dextroamphetamine sulfate 10mg tablet | 3 | 90 | | Dexmethylphenidate HCL (Focalin®) 2.5mg, 5mg, 10mg | 2 | 60 | | Dexmethylphenidate HCL (Focalin XR®) 5mg, 10mg, 15mg, 20mg, 25mg, 30mg, 35mg, 40mg | 1 | 30 | | Dextroamphetamine sulfate (Procentra®) 5mg/5ml solution | 60 | 1800 | | Dextroamphetamine (Xelstrym™) 13.5 MG/9HR, 18 MG/9HR, 4.5 MG/9HR, 9 MG/9HR | 1 | 30 | | Dextroamphetamine (Zenzedi®) 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg tablet | 3 | 90 | | Dextroamphetamine (Zenzedi®) 30mg tablet | 2 | 60 | | Amphetamine (Evekeo®) 5mg | 3 | 90 | | Amphetamine (Evekeo®) 10mg | 4 | 120 | | Amphetamine (Evekeo® ODT) | 3 | 90 | | Lisdexamfetamine dimesylate (Vyvanse®) 20mg, 30mg, 40mg, 50mg, 60mg, 70mg | 1 | 30 | | Methylphenidate HCL ER 24HR (Adhansia™ XR) 25mg, 35mg, 45mg, 55mg, 70mg, 85mg | 1 | 30 | | Methylphenidate (Aptensio XR®) | 1 | 30 | | Methylphenidate HCL (Concerta®) 18mg, 27mg, 54mg | 1 | 30 | | Methylphenidate HCL (Concerta®) 36mg tablet ER | 2 | 60 | Methylphenidate HCL ER 72mg
osmotic release tab | 1 | 30 | | Methylphenidate (Relexxii®) tab ER osmotic release 45mg, 63mg | 1 | 30 | | Methylphenidate (Daytrana patch®) 10mg/9hr, 15mg/9hr, 20mg/9hr, 30mg/9hr | 1 | 30 | | Methamphetamine HCL (Desoxyn®) 5mg tablet | 5 | 150 | | Methylphenidate HCL ER capsule (Jornay™ PM) 20mg, 40mg, 60mg, 80mg, 100mg | 1 | 30 | | Methylpenidate HCL (Metadate CD®) 10mg, 20mg, 30mg, 40mg, 50mg, 60mg | 1 | 30 | | Methylphenidate HCL (Metadate ER®) 10mg, 20mg tablet SA | 3 | 90 | | Methylphenidate HCL (Methylin®) 2.5mg, 10mg chewable tablet | 6 | 180 | | Methylphenidate HCL (Methylin®) 5mg chewable tablet | 3 | 90 | | Methylphenidate HCL (Methylin®) 10mg/5ml | 30 | 900 | | Methylphenidate HCL (Methylin®) 5mg/5ml | 60 | 1800 | | Methylphenidate HCL (Ritalin®) 5mg, 10mg, 20mg | 3 | 90 | | Methylphenidate HCL (Ritalin LA®) 10mg, 40mg capsule | 1 | 30 | | Methylphenidate HCL (Ritalin LA®) 20mg capsule | 3 | 90 | | Methylphenidate HCL (Ritalin LA®) 30mg capsule | 2 | 60 | | Methylphenidate (Quillichew ER®) 20mg, 30mg | 2 | 60 | | Methylphenidate (Quillichew ER®) 40mg | 1 | 30 | | Methylphenidate (Quillivant XR®) 5mg/mL | 12mL | 360 | | Methylphenidate ER disintegrating tabs (Cotempla®) 8.6mg, 17.3mg, 25.9mg | 1 | 30 | | Serdexmethylphenidate-dexmethylphenidate (Azstarys™) | 1 | 30 |
|
| Adzenys XR-ODT™, Adzenys ER®, Adderall®, Adderall® XR, Adhansia XR™, Aptensio XR™, Azstarys™, Concerta®, Dyanavel® XR, Dexedrine®, Dextroamphetamine sulfate, Evekeo®, Focalin®, Focalin® XR, Jornay PM™, Metadate® CD/ER, methylphenidate ER, Mydayis®, QuilliChew ER™, Quillivant XR®, Ritalin®, Ritalin [LA]®, Zenzedi™, Vyvanse®, Cotempla®, Dexedrine® (dextroamphetamine), ProCentra®, Xelstrym™
- Abuse and dependence: CNS stimulants, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Methylin®, Ritalin®, Concerta®, Daytrana®, Relexxii®
- Drug dependence: should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
Desoxyn® - Methamphetamine has a high potential for abuse. It should thus be tried only in weight reduction programs for patients in whom alternative therapy has been ineffective. Administration of methamphetamine for prolonged periods of time in obesity may lead to drug dependence and must be avoided. Particular attention should be paid to the possibility of subjects obtaining methamphetamine for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly. Misuse of methamphetamine may cause sudden death and serious cardiovascular adverse events.
|
| | Adzenys ER® (amphetamine) [prescribing information]. Grand Prairie, TX: Neos Therapeutics; December 2017. Accessed April 17, 2024. Adzenys XR-ODT™ (amphetamine) [prescribing information]. Grand Prairie, TX: Neos Therapeutics; February 2018. Accessed April 17, 2024. Adderall® (dextroamphetamine/amphetamine) [prescribing information]. North Wales, PA: Teva Pharmaceuticals; July 2018. Accessed April 17, 2024. Adderall XR® (dextroamphetamine/amphetamine) [prescribing information]. Social Circle, GA: Shire US Manufacturing Inc.; July 2019. Accessed April 17, 2024. Adhansia XR™ (methylphenidate) [prescribing information]. Wilson, NC: Adlon Therapeutics L.P. July 2019. Accessed April 17, 2024. American Psychiatry Association. Attention-Deficit/Hyperactivity Disorder. In: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association, Arlington, VA 2013. P.59 Aptensio XR™ (methylphenidate) [prescribing information]. Coventry, RI: Rhodes Pharmaeuticals; June 2019. Accessed April 17, 2024. Azstarys™ (serdexmethylphenidate and dexmethylphenidate) [prescribing information]. Grand Rapids, MI: Corium, Inc. June 2021. Accessed April 17, 2024. Concerta® (methylphenidate) [prescribing information]. Horsham, PA: Janssen Pharmaceuticals, Inc; January 2017. Accessed April 17, 2024. Cotempla XR-ODT® (methylphenidate extended-release orally disintegrating tablet) [prescribing information. Grand Prairie, TX: Neos Therapeutics Brands, LLC. June 2017. Accessed April 17, 2024. Daytrana® patch (methylphenidate) [prescribing information]. New York, NY: Noven Therapeutics, LLC; October 2019. Accessed April 17, 2024. Desoxyn® (methamphetamine HCL) [prescribing information]. Lebanon, NJ: Recordati Rare Diseases, Inc; March 2019. Accessed April 17, 2024. Dexedrine® (dextroamphetamine) [prescribing information]. Horsham, PA: Amedra Pharmaceuticals LLC; March 2019. Accessed April 17, 2024. Dextroamphetamine sulfate [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc.; 2015. Accessed April 17, 2024. Dosing Psychotropics: How High Can We Go? TCPR, September 2007, Vol. 5, Issue 9, Complex Psychopharmacology Dyanavel® XR (amphetamine) [prescribing information]. Monmouth Junction, NJ: Tris Pharma Inc; February 2019. Accessed April 17, 2024. Evekeo® (amphetamine) [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals, LLC. September 2016. Accessed April 17, 2024. Evekeo® ODT (amphetamine) [prescribing information]. Atlanta, GA. Arbor Pharmaceuticals, LLC. March 2019. Accessed April 17, 2024. Fayyad J, De Graaf R, Kessler R, et al. Cross-national prevalence and correlates of adult attention-deficit hyperactivity disorders. Br J Psychiatry 2007; 190:420 Focalin® (dexmethylphenidate) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2019. Accessed April 17, 2024. Focalin XR® (dexmethylphenidate) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2019. Accessed April 17, 2024. Jornay PM™ (methylphenidate) [prescribing information]. Cherry Hill, NJ: Ironshore Pharmaceuticals, Inc. April 2019. Accessed April 17, 2024. Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry 2006; 163:716 Kariisa M, Scholl L, Wilson N, et. Al. Drug Overdose Deaths Involving Cocaine and Psychostimulants with Abuse Potential — United States, 2003–2017. MMWR 2019; 68(17);388–395 Metadate CD® (methyphenidate HCL) [prescribing information]. Rochester, NY: Unither Manufacturing, LLC; 2016. Accessed April 17, 2024. Metadate® ER (methylphenidate HCL) [prescribing information]. Rochester, NY: Unither Manufacturing, LLC; April 2018. Accessed April 17, 2024. Methylin® (methylphenidate HCL) [prescribing information]. Florham Park, NJ: Shionogi Inc.; August 2017. Accessed April 17, 2024. Mydayis® (amphetamine mix salt) [prescribing information]. Lexington, MA: Shire US Inc. September 2019. Accessed April 17, 2024. ProCentra® (dextroamphetamine sulfate) [prescribing information]. Charlotte, NC: FSC Laboratories, Inc; 2010. Accessed April 17, 2024. Quillichew ER™ (methylphenidate) [prescribing information]. Cupertino, CA: NextWave Pharmaceuticals, Inc.; August 2018. Accessed April 17, 2024. Quillivant XR® (methylphenidate) [prescribing information]. Cupertino, CA: NextWave Pharmaceuticals, Inc.; August 2018. Accessed April 17, 2024. Relexxii® (methylphenidate hydrochloride extended-release tablets) [prescribing information]. Alpharetta, GA: Vertical Pharmaceuticals, LLC; November 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7677cf9-95e0-4091-ac51-8f237c3f2635. Accessed April 17, 2024. Ritalin® (methylphenidate HCL) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; January 2019. Accessed April 17, 2024. Ritalin LA® (methylphenidate HCL) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2019. Accessed April 17, 2024. Spencer et al. A Large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder. Biological Psychiatry Volume 57, Issue 5, March 1, 2005, pages 456-463 Spencer et al. Efficacy of a mixed amphetamine salts compound in adults with ADHD. Archives general Psychiatry (2001). Swanson, J. Long-acting stimulants: development and dosing. Can Child Adolesc Psychiatr Rev. 2005 Aug; 14(Suppl 1): 4-9. Vyvanse® (lisdexamphetamine dimesylate) [prescribing information]. Exton, PA: Shire LLC; January 2018. Accessed April 17, 2024. Xelstrym™ (dextroamphetamine) [prescribing information]. Miami, FL: Noven Pharmaceuticals; November 2022. Available from: https://www.xelstrym.com/. Accessed April 17, 2024. Yanofski, J. The Dopamine-Dilemma – Part II: Could Stimulants Cause Tolerance, Dependence, and Paradoxical Decompensation? Innovations in Clinical Neuroscience, 2011. Zenzedi™ (dextroamphetamine) [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals, Inc.; 2017 Accessed April 17, 2024.
| 10 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:27 AM | srv_ppsgw_P | Off-Label Use Rx.01.33
Prior Authorization Requirements for Select Drugs Rx.01.202
Weight Loss Agents Rx.01.94
| | Brand Name | Generic Name | | Adderall® [IR/XR] | Amphetamine/Dextroamphetamine | | Mydayis® | Amphetamine/Dextroamphetamine | | Adzenys® [XR ODT/ER] | Amphetamine | | Dyanavel® XR | Amphetamine | | Evekeo® [ODT] | Amphetamine | | Dexedrine® [IR/SA] | Dextroamphetamine sulfate | | ProCentra® | Dextroamphetamine sulfate | | Zenzedi® | Dextroamphetamine | | Xelstrym® | Dextroamphetamine | | Focalin® [IR/XR] | Dexmethylphenidate HCL | | Vvyanse® | Lisdexamfetamine dimesylate | | Adhansia XR™ | Methylphenidate HCL | | Aptensio® XR | Methylphenidate HCL | | Concerta® | Methylphenidate HCL | | Daytrana® | Methylphenidate HCL | | Jornay PM™ | Methylphenidate HCL | | Metadate® [ER/CD] | Methylphenidate HCL | | Methylin® | Methylphenidate HCL | | Ritalin® [IR/LA] | Methylphenidate HCL | | Quillichew® ER | Methylphenidate HCL | | Quillivant® XR | Methylphenidate HCL | | Cotempla® | Methylphenidate ER | | Relexxii® | Methylphenidate ER | | Desoxyn® | Methamphetamine HCL | | Azstarys™ | Serdexmethylphenidate/Dexmethylphenidate |
| stimulants | stimulants | | 410 | | | 7/1/2024 | Rx.01.84 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Insomnia is one of the most common medical complaints, generating more than 5 million office visits per year in the United States. Typical complaints include difficulty falling asleep, staying asleep, and variable sleep. Insomnia is present when all of the following criteria are met:
- A complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early. In children or individuals with dementia, the sleep disturbance may manifest as resistance to going to bed at the appropriate time or difficulty in sleeping without caregiver assistance.
- The above sleep difficulty occurs despite adequate opportunity and circumstances for sleep.
- The impaired sleep produces deficits in daytime function.
Insomnia is classified as short-term, long-term, or other depending upon the duration and causes. Non-24-hour sleep-wake rhythm disorder is characterized by failure of the circadian system to maintain stable alignment (called "entrainment") to the 24-hour day. As a result, the circadian system "free runs" and typically shifts to progressively later phase positions. The most common cause is blindness, as the daily light-dark cycle is the most powerful environmental cue for synchronizing the hypothalamic pacemaker to the 24-hour day.
Sleep problems are often significant in individuals diagnosed with Smith-Magenis Syndrome and include difficulty falling asleep, shortened sleep cycles, frequent and prolonged nocturnal awakening (altered rapid eye movement [REM] sleep), excessive daytime sleepiness, daytime napping, snoring, and bedwetting. Sleep problem appear to be due to an inversion of melatonin secretion. Zolpidem tartrate (Ambien®) is a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Zolpidem tartrate (Ambien CR®) is a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Zolpidem tartrate (Edluar®) and (Zolpimist®) are gamma-aminobutyric acid (GABA) A receptor positive modulators indicated for the treatment of insomnia characterized by difficulties with sleep initiation.
Zolpidem tartrate sublingual tablet (Intermezzo®) is a GABAA agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Zolpidem tartrate sublingual tablet (Intermezzo®) is a GABAA agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Tasimelteon (Hetlioz®/ Hetlioz LQ®oz®) is indicated for:
- Capsules: Treatment of non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
- Oral suspension: Treatment of nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age
Tasimelteon (Hetlioz®/ Hetlioz LQ®) is an agonist of melatonin receptors MT1 and MT2 (greater affinity for the MT2 receptor than the MT1 receptor). Activation of MT1 is thought to preferentially induce sleepiness, while MT2 receptor activation preferentially influences regulation of circadian rhythms.
| The intent of this policy is to communicate the medical necessity criteria for zolpidem tartrate (Ambien® and Ambien CR®), zolpidem (Intermezzo®, Zolpimist®), zolpidem tartrate sublingual tablets (Edluar®), eszopiclone 3mg (Lunesta®) and tasimelteon (Hetlioz®/Hetlioz LQ®) as provided under the member's prescription drug benefit.
| Insomnia
INITIAL CRITERIA: Edluar® 5mg, Zolpimist® are approved when ALL of the following are met: - Diagnosis of insomnia; and
- Member is 18 years of age or older; and
- One of the following:
- Inadequate response or inability to tolerate TWO of the following:
- Eszopiclone
- Zaleplon
- Zolpidem; OR
- Inability to swallow capsules/tablets (i.e., dysphagia, gastrointestinal [GI] tubes)
INITIAL CRITERIA: Any of the following high dose products (brand and generic): zolpidem tartrate (Ambien®) 10mg, zolpidem tartrate ER (Ambien® CR) 12.5mg, eszopiclone (Lunesta®) 3mg or Edluar® 10mg is approved when ALL of the following are met: - Diagnosis of insomnia; and
- Member is 18 years of age or older; and
- Patient has been counseled on practices associated with good sleep hygiene (e.g., avoiding stimulants such as caffeine, nicotine, alcohol close to bedtime, etc.); and
- Inadequate response to a two-week trial of the lower dose; and
- For brand products with generic equivalents only, inadequate response or inability to tolerate a generic equivalent
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Edluar® 5mg, Zolpimist®, zolpidem tartrate (Ambien®) 10mg, zolpidem tartrate ER (Ambien® CR) 12.5mg, eszopiclone (Lunesta®) 3mg, or Edluar® 10mg is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
Non-24 hour Sleep-Wake Disorder
INITIAL CRITERIA Tasimelteon (Hetlioz®) is approved when ALL of the following are met: - Prescribed by or in consultation with a sleep specialist or neurologist; and
- Diagnosis of Non-24-hour Sleep-Wake Disorder (also known as free-running disorder, free-running or non-entrained type circadian rhythm sleep disorder, or hypernychthemeral syndrome); and
- Member is 18 years of age or older; and
- Member is totally blind (has no light perception); and
- Member has circadian period greater than 24 hours; and
- For brand Hetlioz only, inadequate response or inability to tolerate generic tasimelteon
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA: Hetlioz® is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
Smith-Magenis Syndrome
INITIAL CRITERIA Tasimelteon (Hetlioz®/Hetlioz LQ®) is approved when ALL of the following are met: - Prescribed by or in consultation with a sleep specialist or neurologist; and
- Diagnosis of Smith-Magenis Syndrome; and
- Member experiences nighttime sleep disturbances (i.e., difficulty falling asleep, frequent nighttime waking and early waking); and
- One of the following:
- For Hetlioz only, member is 16 years of age or older; or
- For Hetlioz LQ only, member is 3 to 15 years of age; and
- For brand Hetlioz capsules only, inadequate response or inability to tolerate generic tasimelteon
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Hetlioz®/Hetlioz LQ® is re-approved when there is documentation of positive clinical response to therapy (i.e., improvement in nighttime total sleep time, improvement in nighttime sleep quality)
Reauthorization duration: 2 years
|
| Complex Sleep Behaviors: zolpidem tartrate (Ambien® and Ambien CR®), zolpidem (Intermezzo®, Zolpimist®), zolpidem tartrate sublingual tablets (Edluar®), eszopiclone 3mg (Lunesta®)
Complex sleep behaviors including sleepwalking, sleep driving, and engaging in other activities while not fully awake have been reported following use of zolpidem tartrate and eszopiclone. Some of these events have resulted in serious injuries, including death. Discontinue immediately if a patient experiences a complex sleep behavior.
| | Allain H, Bentue-Ferrer D, Breton SL, Polard E, Gandon JM. Preference of insomniac patients between a single dose of zolpidem 10 mg versus zaleplon 10 mg. Hum Psychopharmacol. 2003;18(5):369-374. Ambien® (zolpidem tartrate) [prescribing information]. Bridgewater, NJ: sanofi-aventis; February 2022. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&type=display. Accessed April 17, 2024.
Ambien CR® (zolpidem tartrate) [package insert]. Bridgewater, NJ: sanofi-aventis; February 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=404c858c-89ac-4c9d-8a96-8702a28e6e76&type=display. Accessed April 17, 2024.
Ancoli-Israel S, Walsh JK, Mangano RM, Fujimori M. Zaleplon, a novel nonbenzodiazepine hypnotic, effectively treats insomnia in elderly patients without causing rebound effects. Prim Care Companion J Clin Psychiatry. 1999;1(4):114-120. Bonnet MH, Arand DL. Risk factors, comorbidities, and consequences of insomnia in adults. UpToDate. August 2023. Available at: https://www.uptodate.com/contents/overview-of-insomnia?source=search_result&search=insomnia&selectedTitle=2~150. Accessed April 17, 2024. Elie R, Ruther E, Farr I, Emilien G, Salinas E. Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. Zaleplon Clinical Study Group. Clin Psychiatry. 1999;60(8):536-544. Edluar® [package insert]. Somerset, NJ: Meda Pharmaceuticals, Inc.; August 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a32884d0-85b5-11de-8a39-0800200c9a66&type=display. Accessed April 17, 2024.
Fry J, Scharf M, Mangano R, Fujimori M. Zaleplon improves sleep without producing rebound effects in outpatients with insomnia. Zaleplon Clinical Study Group. Int Clin Psychopharm. 2000;15(3):141-152. Hetlioz® (tasimelteon) [prescribing information]. Vanda Pharmaceuticals, Inc.: Washington, DC.; January 2024. Available at:https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ca4a9b63-708e-49e9-8f9b-010625443b90&type=display. Accessed April 17, 2024.
Intermezzo® (zolpidem tartrate) [prescribing information]. Stamford, CT: Purdue Pharma LP; November 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=913b6cfe-1fb0-44a8-817a-26374bbce995&type=display. Accessed April 17, 2024.
Lunesta® (eszopiclone) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc. August 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd047b2b-05a6-4d99-95cb-955f14bf329f. Accessed April 17, 2024.
Krystal A, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: Results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep. 2003;26(7):793-799. Rosenberg RP. Eszopiclone, a novel non-benzodiazepine sedative-hypnotic: Efficacy and safety in a model of transient insomnia (Abstract). Sleep. 2002;25(suppl):A68. Roth T, Krystal A, Walsh J, Roehrs T, Wessel T, Caron J. Twelve months of nightly eszopiclone treatment in patients with chronic insomnia: Assessment of long-term efficacy and safety (Abstract). Sleep. 2004;27(suppl):A260. Goldstein C. Overview of circadian sleep-wake rhythm disorders. UpToDate. December 2023. Available at: https://www.uptodate.com/contents/overview-of-circadian-sleep-wake-rhythm-disorders?source=search_result&search=non%2024&selectedTitle=1~94. Accessed April 17, 2024.
Zammit GK, McNabb LJ, Caron J, Amato DA, Roth T. Efficacy and safety of eszopiclone across 6 weeks of treatment for primary insomnia. Curr Med Res Opin. 2004:20(12):1979-1991. Zolpimist® (zolpidem tartrate spray) [prescribing information]. Louisville, KY: Magna Pharmaceuticals; August 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b2e26965-30bd-4dca-869d-8a70b23b6d62&type=display. Accessed April 17, 2024.
| 19 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:27 AM | srv_ppsgw_P | Off-Label Use Rx.01.33
Quantity Lvel Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit Rx.01.76
| | Brand Name | Generic Name | | Ambien® [CR] | zolpidem tartrate immediate and extended release (PA applies to generic 10mg IR and 12.5mg CR) | | Edluar® | zolpidem sublingual tablets | | Zolpimist® | zolpidem | | Intermezzo® | zolpidem | | Lunesta® | eszopiclone | Hetlioz®/Hetlioz LQ®
| tasimelton |
| Ambien®, Ambien CR®, Intermezzo®, Zolpimist®, Edluar®, Lunesta®, Hetlioz®/Hetlioz LQ® | zolpidem tartrate, zolpidem tartrate sublingual tablets, eszopiclone 3mg, tasimelteon | | 411 | | | 7/1/2024 | Rx.01.124 | Commercial | Oluwadamilola.Oyenusi@ibx.com | Q1-2024 | Narcolepsy results from the loss of the neuropeptides, orexin-A and orexin-B (also known as hypocretin-1 and hypocretin-2), which have excitatory effects on the ox1 and ox2 receptors on postsynaptic neurons. Narcolepsy is a clinical syndrome of daytime sleepiness with cataplexy, hypnagogic hallucinations, and sleep paralysis. It is the second most common cause of disabling daytime sleepiness after obstructive sleep apnea. Typical age of onset of narcolepsy is teens to twenties. Patients with type 1 narcolepsy (narcolepsy with cataplexy) typically present with moderate to severe daytime sleepiness, transient facial weakness or falls triggered by joking or laughter (partial or complete cataplexy), or the inability to move for one or two minutes immediately after awakening or just before falling asleep. Patients with type 2 narcolepsy do not have cataplexy. Sodium oxybate, a CNS depressant, is the sodium salt of gamma hydroxybutyrate, a metabolite of GABA. It is hypothesized that the therapeutic effects of Xyrem® on cataplexy and excessive daytime sleepiness are mediated through GABA-B actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. The exact mechanism of sodium oxybate in narcolepsy is unknown. Xywav™ is a CNS depressant. The exact mechanism of action in the treatment of narcolepsy is unknown. Xywav™ is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate). Gamma-hydroxybutyrate (GHB) is an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of Xywav™ on cataplexy and excessive daytime sleepiness are mediated through GABA-B actions during sleep at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. The active moiety of oxybate salts is the same as that of sodium oxybate (Xyrem®), and dosing is the same; the only difference is that oxybate salts (Xywav™) have 90 percent less sodium. Sodium oxybate solution (Xyrem®) is indicated for the treatment
of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of
age and older with narcolepsy.
Sodium oxybate extended-release oral suspension (Lumryz™) is indicated for the treatment
of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Calcium, magnesium, potassium and sodium oxybates (Xywav™) is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy and idiopathic hypersomnia (IH) in adults. | The intent of this policy is to communicate the medical necessity criteria for sodium oxybate (Xyrem®/Lumryz™) and calcium, magnesium, potassium and sodium oxybates (Xywav™) as provided under the member's prescription drug benefit.
| Cataplexy with narcolepsy (Type 1)
INITIAL CRITERIA: Sodium oxybate (Xyrem®) solution or calcium, magnesium, potassium and sodium oxybates (Xywav™) is approved when ALL of the following are met:
- Diagnosis of Cataplexy with narcolepsy (Type 1); and
- Member is 7 years of age or older; and
- Diagnosis was confirmed by ONE of the following tests:
- Polysomnography (PSG); or
- Multiple sleep latency test (MSLT); and
- Prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist; and
- No concurrent use of sedative hypnotics and alcohol; and
Symptoms of cataplexy are present; and
Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present; and - For Xyrem® solution only, inadequate response or inability to tolerate sodium oxybate solution (by Hikma)
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Sodium oxybate (Xyrem®) solution or calcium, magnesium, potassium and sodium oxybate (Xywav™) is re-approved when ALL of the following are met: - Documentation to support the efficacy associated with the current regimen (including but not limited to reduction in the frequency of cataplexy attacks or an improvement in the Epworth sleepiness scale); and
- There is no claim history of a sedative hypnotic agents within one year of the request; and
- For Xyrem® solution only, inadequate response or inability to tolerate sodium oxybate solution (by Hikma); and
- Yearly evaluation by a neurologist, psychiatrist, or sleep specialist
Reauthorization duration: 12 months
INITIAL CRITERIA: Sodium oxybate suspension extended-release (Lumryz™) is approved when ALL of the following are met:
- Diagnosis of Cataplexy with narcolepsy (Type 1); and
- Member is 18 years of age or older; and
- Diagnosis was confirmed by ONE of the following tests:
- Polysomnography (PSG); or
- Multiple sleep latency test (MSLT); and
- Prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist; and
Symptoms of cataplexy are present; and
Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present; and
- No concurrent use of sedative hypnotics and alcohol
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Sodium oxybate suspension extended-release (Lumryz™) is re-approved when ALL of the following are met: - Documentation to support the efficacy associated with the current regimen (including but not limited to reduction in the frequency of cataplexy attacks or an improvement in the Epworth sleepiness scale); and
- There is no claim history of a sedative hypnotic agents within one year of the request; and
- Yearly evaluation by a neurologist, psychiatrist, or sleep specialist
Reauthorization duration: 12 month
_____________________________________________________________________________________________________
Excessive daytime sleepiness in narcolepsy (Type 2)
INITIAL CRITERIA: Sodium oxybate (Xyrem®) solution or calcium, magnesium, potassium and sodium oxybates (Xywav™) is approved when ALL of the following are met: - Diagnosis of Excessive daytime sleepiness in narcolepsy (Type 2); and
- Member is 7 years of age or older; and
- Diagnosis was confirmed by ONE of the following tests:
- Polysomnography (PSG); or
- Multiple sleep latency test (MSLT); and
- Inadequate response or inability to tolerate ALL of the following:
- Modafinil or armodafinil; and
- One of the following:
- One stimulant product (e.g., amphetamine, methylphenidate); or
- History of or potential for a substance use disorder; and
- Sunosi®; and
- Prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist; and
- No concurrent use of sedative hypnotics and alcohol; and
- Symptoms of cataplexy are absent; and
- Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present; and
- For Xyrem® solution only, inadequate response or inability to tolerate sodium oxybate solution (by Hikma)
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Sodium oxybate (Xyrem®) solution or calcium, magnesium, potassium and sodium oxybates (Xywav™) is re-approved when ALL of the following are met:
- Documentation to support the efficacy associated with the current regimen (including but not limited to reduction in the frequency of cataplexy attacks or an improvement in the Epworth sleepiness scale); and
- There is no claim history of a sedative hypnotic agents within one year of the request; and
- For Xyrem® solution only, inadequate response or inability to tolerate sodium oxybate solution (by Hikma); and
- Yearly evaluation by a neurologist, psychiatrist, or sleep specialist
Reauthorization duration: 12 months
INITIAL CRITERIA: Sodium oxybate suspension extended-release (Lumryz™) is approved when ALL of the following are met:
- Diagnosis of Excessive daytime sleepiness in narcolepsy (Type 2); and
- Member is 18 years of age or older; and
- Diagnosis was confirmed by ONE of the following tests:
- Polysomnography (PSG); or
- Multiple sleep latency test (MSLT); and
- Inadequate response or inability to tolerate ALL of the following:
- Modafinil or armodafinil; and
- One of the following:
- One stimulant product (e.g., amphetamine, methylphenidate); or
- history of or potential for a substance use disorder; and
- Sunosi®; and
- Prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist; and
- Symptoms of cataplexy are absent; and
- Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present; and
- No concurrent use of sedative hypnotics and alcohol
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Sodium oxybate suspension extended-release (Lumryz™) is re-approved when ALL of the following are met: - Documentation to support the efficacy associated with the current regimen (including but not limited to reduction in the frequency of cataplexy attacks or an improvement in the Epworth sleepiness scale); and
- There is no claim history of a sedative hypnotic agents within one year of the request; and
- Yearly evaluation by a neurologist, psychiatrist, or sleep specialist
Reauthorization duration: 12 months
______________________________________________________________________________________________ Idiopathic Hypersomnia (IH)
INITIAL CRITERIA: Calcium, magnesium, potassium and sodium oxybates (Xywav™) is approved when ALL of the following are met: - Diagnosis of idiopathic hypersomnia; and
- Member is 18 years of age or older; and
- Diagnosis was confirmed by ONE of the following tests:
- Polysomnography (PSG); or
- Multiple sleep latency test (MSLT); and
- Symptoms of excessive daytime sleepiness (e.g., nap duration of longer than 60 minutes) are present; and
- Prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist; and
- No concurrent use of sedative hypnotics and alcohol
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Calcium, magnesium, potassium and sodium oxybates (Xywav™) is re-approved when ALL of the following are met:
- Documentation demonstrating a reduction in symptoms of excessive daytime sleepiness associated with therapy; and
- There is no claim history of a sedative hypnotic agents within one year of the request; and
- Yearly evaluation by a neurologist, psychiatrist, or sleep specialist
Reauthorization duration: 12 months
|
| WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression Xyrem®/Xywav™/Lumryz™ is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Xyrem®/Xywav™/Lumryz™. Many patients who received Xyrem®/Xywav™/Lumryz™ during clinical trials in narcolepsy were receiving central nervous system stimulants. Abuse and Misuse Xyrem®/Xywav™/Lumryz™ is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death. Because of the risks of CNS depression and abuse and misuse, Xyrem®/Xywav™/Lumryz™ is available only through a restricted program called the Xyrem®/Xywav™/Lumryz™ REMS Program
|
| | Scammel TE. Treatment of narcolepsy in adults. UpToDate. May 2023. Available at: https://www.uptodate.com/contents/treatment-of-narcolepsy-in-adults?source=search_result&search=modafinil%20narcolepsy&selectedTitle=1~143#H1. Accessed April 17, 2024.
Lumryz™ (sodium oxybate) [package insert]. Chesterfield, MO: Avadel CNS Pharmaceuticals, LLC. May 2023. Available from: https://www.avadel.com/lumryz-prescribing-information.pdf. Accessed November 20, 2023. Xyrem® (sodium oxybate) [package insert]. Palo Alto, CA. Jazz Pharmaceuticals. April 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=926eb076-a4a8-45e4-91ef-411f0aa4f3ca&type=display. Accessed November 20, 2023. Xywav™ (calcium, magnesium, potassium, and sodium oxybates) [prescribing information]. Palo Alto, CA. Jazz Pharmaceuticals. April 2023. Available from: https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf. Accessed November 20, 2023. Scammell TE. Clinical features and diagnosis of narcolepsy in adults. UpToDate website. Last updated July 2022. Available at http://www.uptodate.com/. Accessed November 20, 2023.
| 16 | 3/14/2024 | 3/14/2025 | 9/21/2024 9:12 AM | srv_ppsgw_P | Off-labe use Rx.01.33
Quantity Level Limits Covered for Pharmaceuticals Covered Under the Prescription Drug Benefit Rx.01.76
| | Drug name | Generic name | | Xyrem® | sodium oxybate solution | | Xywav™ | calcium, magnesium, potassium and sodium oxybates | | Lumryz™ | sodium oxybate extended-release oral suspension |
| Xyrem®, Lumryz™, Xywav™ | Sodium oxybate/calcium, magnesium, potassium, sodium oxybates | | 412 | | | 7/1/2024 | Rx.01.273 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder that causes muscle weakness, disability, and eventually death, with a median survival of three to five years. Incidence rates for ALS in Europe and North America range between 1.5 and 4.7 per 100,000 person-years, while prevalence rates range between 2.7 and 7.4 per 100,000 person-years. The loss of motor neurons results in the primary clinical symptoms and signs of ALS.
Sodium phenylbutyrate is a histone deacetylase inhibitor that reduces an adaptive stress response in the endoplasmic reticulum. Taurursodiol (also known as ursodoxicoltaurine) appears to increase the threshold of cellular apoptosis by maintaining mitochondrial integrity through reduced membrane permeability. A coformulation of both agents, sodium phenylbutyrate-taurursodiol (PB-TURSO), is used to reduce neuronal cell death.
Relyvrio™ is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
|
The intent of this policy is to communicate the medical necessity criteria for Sodium phenylbutyrate and Taurursodiol (Relyvrio™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Sodium phenylbutyrate and taurursodiol (Relyvrio™) is approved when ALL of the following are met: - Diagnosis of amyotrophic lateral sclerosis (ALS); and
- Diagnosis of ALS is further supported by neurogenic changes in electromyography (EMG); and
- Baseline functional ability has been conducted prior to initiating treatment (e.g., speech, walking, climbing stairs, etc.); and
- Other differential diagnoses (e.g., multifocal motor neuropathy, cervical radiculomyelopathy, inflammatory myopathies, spinobulbar muscular atrophy, myasthenia gravis, etc.) have been ruled out); and
- Member has a percent (%) forced vital capacity (%FVC) or slow vital capacity (%SVC) greater than or equal to 60% at the start of treatment; and
- Member does not require permanent noninvasive ventilation or invasive ventilation; and
- Member has had ALS symptoms for less than or equal to 18 months; and
- Member is 18 years of age or older; and
- Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA Sodium phenylbutyrate and taurursodiol (Relyvrio™) is re-approved when BOTH of the following are met:
- Documentation of slowed disease progression from baseline; and
- Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS
Reauthorization duration: 6 months
|
| | | Maragakis NJ. Epidemiology and pathogenesis of amyotrophic lateral sclerosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 11, 2024.
Goyal NA. Disease-modifying treatment of amyotrophic lateral sclerosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 11, 2024.
Relyvrio™ (sodium phenylbutyrate and taurursodiol) [package insert]. Cambridge, MA: Amylyx Pharmaceuticals, Inc; September 2022. Available at https://www.relyvrio.com/RELYVRIO-US-Prescribing-Information.pdf. Accessed April 11, 2024.
| 3 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:28 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Relyvrio™ | Sodium phenylbutyrate and Taurursodiol
|
| Relyvrio™ | Sodium phenylbutyrate and Taurursodiol | | 413 | | | 7/1/2024 | Rx.01.277 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Proteinuria, also called albuminuria, is elevated protein in the urine. It is not a disease in and of itself but a symptom of certain conditions affecting the kidneys. Typically, too much protein in the urine means that the kidneys’ filters — the glomeruli — are not working properly and are allowing too much protein to escape in the urine. IgA nephropathy is an autoimmune disease resulting from dysregulation of mucosal-type IgA immune responses.
Sparsentan is a single molecule with antagonism of the endothelin type A receptor (ETAR) and the angiotensin II type 1 receptor (AT1R). Sparsentan has high affinity for both the ETAR (Ki= 12.8 nM) and the AT1R (Ki=0.36 nM), and greater than 500-fold selectivity for these receptors over the endothelin type B and angiotensin II subtype 2 receptors. Endothelin-1 and angiotensin II are thought to contribute to the pathogenesis of IgAN via the ETA R and AT1R, respectively.
Filspari™ is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
| The intent of this policy is to communicate the medical necessity criteria for Sparsentan (Filspari™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Sparsentan (Filspari) is approved when all of the following are met:
- Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy; and
- Documentation is provided that member is at risk of rapid disease progression [e.g., generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g, or by other criteria such as clinical risk scoring using the International IgAN Prediction tool]; and
- Medication will be used to reduce proteinuria; and
- Member has an estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73m2; and
- Member had an inadequate response or inability to tolerate a minimum 90-day trial of a maximally tolerated dose of one of the following:
- Angiotensin-receptor blockers (ARB) (e.g., losartan, valsartan); or
- Angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril); and
- Medication will not be used in combination with any of the following:
- Angiotensin receptor blockers
- Endothelin receptor antagonists (ERAs) (e.g., ambrisentan, bosentan, Opsumit)
- Aliskiren; and
- Member is 18 years or age or older; and
- Prescribed by or in consultation with a nephrologist
Initial authorization duration: 1 year CONTINUATION CRITERIA: Sparsentan (Filspari) is approved when BOTH of the following are met: - Documentation of positive clinical response to therapy from baseline as demonstrated by a decrease in urine protein-to-creatinine ratio (UPCR); and
- Prescribed by or in consultation with a nephrologist; and
- Medication is not taken in combination with any of the following:
Angiotensin receptor blocker or angiotensin receptor-neprilysin inhibitor
Endothelin receptor antagonists (ERAs) (e.g, ambrisentan, bosentan, Opsumit) Aliskiren
Continuation authorization duration: 1 year
|
| WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY FILSPARI is only available through a restricted distribution program called the FILSPARI Risk Evaluation and Mitigation Strategies (REMS) because of these risks. Some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure. Measure liver aminotransferases and total bilirubin prior to initiation of treatment and ALT and AST monthly for 12 months, then every 3 months during treatment. Interrupt treatment and closely monitor patients developing aminotransferase elevations more than 3x Upper Limit of Normal (ULN). Based on animal data, FILSPARI can cause major birth defects if used during pregnancy. Pregnancy testing is required before, during, and after treatment. Patients who can become pregnant must use effective contraception prior to initiation of treatment, during treatment, and for one month after.
| | Filspari™ (sparsentan) [package insert]. San Diego, CA: Travere Therapeutics, Inc. February 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216403s000lbl.pdf. Accessed April 16, 2024.
Cattran DC. IgA nephropathy: Treatment and prognosis. UpToDate. March 2024. Available at: https://www.uptodate.com. Accessed April 16, 2024.
“Proteinuria." JHM, 19 Nov. 2019, www.hopkinsmedicine.org/health/conditions-and-diseases/proteinuria.
| 2 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:28 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Filspari™ | Sparsentan |
| Filspari™ | Sparsentan | | 425 | | | 7/1/2024 | Rx.01.289 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | In the United States, it is estimated that 2.7 to 3.9 million people are chronically infected with HCV. Chronic HCV infection occurs after acute infection with the virus. It is estimated that approximately 75%-85% of acute infections become chronic. The remaining 15%-25% clear the virus without treatment and do not develop chronic HCV. Genotype (GT) 1 is the most prevalent, with the breakdown as follows: GT 1a: 46.2%, GT1b: 26.3%, GT2: 10.7%, GT3: 8.9%, GT4: 6.3%, GT6: 1.1%, mixed GT/ other: 0.5%.
The goal of treating chronic HCV is to "reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a sustained virologic response (SVR)." SVR is defined as the "continued absence of detectable HCV RNA at least 12 weeks after completion of therapy" and is considered a marker for cure of HCV. Several benefits are associated with HCV cure, including decreases in liver inflammation, progression to liver fibrosis, hepatocellular carcinoma, liver-related mortality and liver transplantation.
Chronic hepatitis B describes a spectrum of disease usually characterized by the presence of detectable hepatitis B surface antigen in the blood or serum for longer than 6 months. In some individuals, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). The goal of treatment for chronic hepatitis B is to prevent cirrhosis, HCC and liver failure.
Pegylated recombinant human interferon alfa-2a is an inducer of the innate antiviral immune response.
PEGASYS is an inducer of the innate immune response indicated for the
treatment of:
Chronic Hepatitis C (CHC) Adult Patients: In combination therapy with other hepatitis C virus drugs
for adults with compensated liver disease. PEGASYS monotherapy is
indicated only if patient has contraindication or significant intolerance to
other HCV drugs. Pediatric Patients: In combination with ribavirin for pediatric patients 5
years of age and older with compensated liver disease
Chronic Hepatitis B (CHB) Adult Patients: Treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) infection who have compensated
liver disease and evidence of viral replication and liver inflammation Pediatric Patients: Treatment of non-cirrhotic pediatric patients 3 years
of age and older with HBeAg-positive CHB and evidence of viral
replication and elevations in serum alanine aminotransferase (ALT)
| The intent of this policy is to communicate the medical necessity criteria for peginterferon alfa-2a (Pegasys) as provided under the member's prescription drug benefit.
| Chronic Hepatitis C (CHC) INITIAL CRITERIA: Peginterferon alfa-2a (Pegasys®) is approved when ALL of the following are met: - Diagnosis of Chronic Hepatis C (CHC); and
- Member is without decompensated liver disease (defined as Child-Pugh Class B or C); and
- One of the following:
- Used in combination with one of the following:
- Sovaldi (sofosbuvir); or
- Ribavirin; or
- Inadequate response or inability to tolerate all other HCV agents (e.g., Sovaldi (sofosbuvir), ribavirin); and
- Prescribed by or in consultation with one of the following:
- Hepatologist
- Gastroenterologist
- Infectious disease specialist
- HIV specialist certified through the American Academy of HIV medicine
Initial authorization duration: 28 weeks REAUTHORIZATION CRITERIA: Peginterferon alfa-2a (Pegasys®) is re-approved when ALL of the following are met: - Member has an undetectable HCV RNA at week 24; and
- Additional treatment weeks of peginterferon are required to complete treatment regimen; and
- Member has not exceeded 48 weeks of therapy with peginterferon; and
- Prescribed by or in consultation with one of the following:
- Hepatologist
- Gastroenterologist
- Infection disease specialist
- HIV specialist certified through the American Academy of HIV medicine
Reauthorization duration: 20 weeks _______________________________________________________________________________________________
Chronic Hepatitis B (CHB)
Peginterferon alfa-2a (Pegasys®) is approved when BOTH of the following are met: - Diagnosis of chronic hepatitis B infection; and
- Member is without decompensated liver disease (defined as Child-Pugh Class B or C)
Authorization duration: 48 weeks
|
| WARNING: RISK OF SERIOUS DISORDERS
See full prescribing information for complete boxed warning. Risk of Serious Disorders
May cause or aggravate fatal or life-threatening neuropsychiatric,
autoimmune, ischemic, and infectious disorders. Monitor closely and
withdraw therapy with persistently severe or worsening signs or
symptoms of the above disorders
| | American Association for the Study of Liver Disease, Infectious Diseases Society or America, International Antiviral Society-USA. Recommendations for testing, managing and treating Hepatitis C. Available from https://www.hcvguidelines.org/. Accessed April 17, 2024.
Hepatitis B (chronic): diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2017 Oct. (NICE Clinical Guidelines, No. 165.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK553697/. Accessed April 17, 2024.
| 1 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:30 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Pegasys | peginterferon alfa-2a |
| Pegasys® | Peginterferon alfa-2a | | 426 | | | 7/1/2024 | Rx.01.290 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Infantile hemangioma is a common benign vascular tumors in infancy and present in up to 5% of children. In most cases, infantile hemangioma is not visibile after birth or is only present as a faint discoloration with a light halo and become evident in a period of one to two weeks after birth. Most of the infantile hemangioma presents in the face and neck region. In the case of deeply localized infantile hemangiomas presenting as bluish tumors without clear borders, the diagnosis may be delayed until up to 3 months after birth. The natural cycle of infantile hemangioma consists of three phases: the rapid proliferation phase (with the fastest growth between 5.5 and 7.5 weeks), the plateau phase, and the slow involution phase. The maximum size is achieved at around 9 months on average, and regression is completed by the age of 4 years in 90% of cases. The possible complications of infantile hemangiomas include ulceration, disfigurement, obstruction, and functional impairment. Most hemangiomas do not require immediate treatment due to their self-involuting pattern of growth; therefore, “active observation” is recommended. However, about 10% of cases are referred to as high-risk hemangiomas because of their size, character, or location and are in need of immediate intervention.
HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. The mechanism of HEMANGEOL’s effects on infantile hemangiomas is not well
understood.
| The intent of this policy is to communicate the medical necessity criteria for propranolol (Hemangeol) oral solution as provided under the member's prescription drug benefit.
| Propranolol oral solution (Hemangeol™) is approved when all of the following are met: - Diagnosis of proliferating infantile hemangioma; and
- Member is less than 1 year of age.
Authorization Duration: through member's age of 12 months
| | | Hemangeol (propranolol hydrochloride oral solution) [package insert]. Parsippany, NJ: Pierre Fabre Pharmaceuticals, Inc. June 2021. Available: https://hemangeol.com/wp-content/uploads/2023/01/Prescribing-Information-Hemangeol.pdf. Accessed April 17, 2024. Léauté-Labrèze C., Harper J.I., Hoeger P.H. Infantile haemangioma. Lancet. 2017;390:85–94. doi: 10.1016/S0140-6736(16)00645-0. Accessed April 17, 2024. Léauté-Labrèze C., De La Roque E.D., Hubiche T., Boralevi F., Thambo J.-B., Taïeb A. Propranolol for Severe Hemangiomas of Infancy. N. Engl. J. Med. 2008;358:2649–2651. doi: 10.1056/NEJMc0708819. Accessed April 17, 2024.
| 1 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:30 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Hemangeol | Propranolol hydrochloride |
| Hemangeol™ | Propranolol oral solution | | 431 | | | 7/1/2024 | Rx.01.219 | Commercial | Oyenusi, Oluwadamilola | Q1-2024 | Parkinson's disease (PD) is a neurodegenerative disorder caused by progressive dopamine depletion in the nigrostriatal pathway of the brain. PD is characterized by manifestations of tremor, bradykinesia, and rigidity. PD is a motor condition that includes neuropsychiatric and other nonmotor manifestations. The dopamine precursor levodopa is the most effective drug for the symptomatic treatment of PD, however; levodopa-induced complications (eg, motor fluctuations [“wearing off" phenomenon], dyskinesia, dystonia) develop in at least 50% of patients after 5 to 10 years of levodopa treatment. The risk of motor complications increases with higher levodopa doses and younger age of PD onset. The cause of motor fluctuations is not clear, but it is hypothesized that they evolve as PD progresses because progressive degeneration of the nigrostriatal dopaminergic pathway reduces the ability of nerve terminals to store and release dopamine. The response to exogenous levodopa becomes more pulse-like due to the inability of the nerve terminals to store and release dopamine. Levodopa has a short half-life (90 minutes), rapid cycling pharmacokinetics (PK), and erratic intestinal absorption related to slowed intestinal motility. The four main drugs or classes of drugs that have anti-parkinson activity are monoamine oxidase type B (MAO B) inhibitors, amantadine, dopamine agonists and levodopa. Initial therapy is individualized and requires a flexible trial-and-error approach. Individuals who exhibit mild symptoms with minimal impact on daily life are good candidates for MAO B inhibitor as initial therapy. For individuals with mild to moderate symptoms that impact daily living, either dopamine agonist or levodopa is recommended in individuals younger than 65; levodopa is preferred in those older than 65 years of age. Levodopa is the drug of choice in individuals with moderate to severe symptoms regardless of age. Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier and is presumably converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa relieves symptoms of PD Levodopa (Inbrija™) inhalation powder is indicated for the intermittent treatment of OFF episodes in patients with PD treated with carbidopa/levodopa. Istradefylline (Nourianz™) is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing “off" episodes. The precise mechanism by which istradefylline exerts its therapeutic effect in PD is unknown. The mechanism by which apomorphine hydrochloride treats Parkinson Disease is unknown. Apomorphine is a non-ergoline dopamine agonist that has high in-vitro affinity for the dopamine D4 receptor, and moderate affinity for the dopamine D2, D3, D5, and adrenergic a1D, a2B, and a2C receptors. Activity is suspected to be due to stimulation of post-synaptic dopamine D2-type receptors within the caudate-putamen in the brain. Apomorphine hydrochloride (Kynmobi™) sublingual film is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of “off" episodes in patients with Parkinson's disease (PD). Apomorphine hydrochloride (Apokyn®) injection for subcutaneous use is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of hypomobility, “off" episodes (“end-of-dose wearing off" and unpredictable “on/off" episodes) associated with advanced Parkinson's disease.
Adding a catechol-O-methyltransferase (COMT) inhibitor can prolong and potentiate the levodopa effect and thereby reduce "off" time when used as adjunctive therapy with levodopa.
| The intent of this policy is to communicate the medical necessity criteria for levodopa inhalation (Inbrija™), istradefylline (Nourianz™), and apomorphine (Apokyn®, Kynmobi™) as provided under the member's prescription drug benefit.
| | Adjunctive treatment for Parkinson's Disease | Parkinson's Disease
INITIAL CRITERIA: Levodopa inhalation (Inbrija™), or istradefylline (Nourianz™) is approved when ALL of the following are met: - Diagnosis of Parkinson's disease and member is experiencing intermittent off episodes; and
- Member is 18 years of age or older; and
- Concurrent use of carbidopa/levodopa containing product at maximally tolerated dose; and
- Prescribed by or in consultation with a neurologist; and
- Member had inadequate response or inability to tolerate TWO of the following:
- MAO-B Inhibitor (e.g., rasagiline, selegiline); or
- Dopamine Agonist (e.g., pramipexole, ropinirole); or
- COMT inhibitor (e.g., entacapone)
Initial authorization duration: 2 years
REAUTHORIZATION CRITRIA: Levodopa inhalation (Inbrija®), or istradefylline (Nourianz™) is re-approved when ALL of the following are met:
- Documentation of positive clinical response to therapy; and
- Concurrent use of carbidopa/levodopa containing product
__________________________________________________________________________________________
Advanced Parkinson's Disease
INITIAL CRITERIA: Apomorphine (Apokyn®, Kynmobi™) is approved when ALL of the following are met: - Diagnosis of advanced Parkinson's disease and member is experiencing intermittent "off" episodes; and
- Member is 18 years of age or older; and
- One of the following:
- Member is receiving medication in combination with other medications for the treatment of Parkinson's disease at maximally tolerated dose (e.g., carbidopa/levodopa, pramipexole, ropinirole, etc…); or
- Member has a contraindication or intolerance to other medications for the treatment of Parkinson's disease; and
- Member is not using the medication with any 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron); and
- For Apomorphine (Apokyn®) inadequate response or inability to tolerate apomorphine (Kynmobi™); and
- Prescribed by or in consultation with a neurologist
Initial authorization duration: 2 years
REAUTHORIZATION CRITRIA: Apomorphine (Apokyn®, Kynmobi™) is re-approved with documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
|
| | | Apokyn® (apomorphine hydrochloride injection) [prescribing information]. Louisville, KY: US WorldMeds, LLC.; June 2022. Available from: https://www.apokyn.com/sites/all/themes/apokyn/content/resources/Apokyn_PI.pdf. Accessed April 17, 2024. Inbrija™ [package insert]. Ardsley, NY. Acorda Therapeutics, Inc. December 2022. Available at: https://www.inbrija.com/prescribing-information.pdf. Accessed April 17, 2024. Kynmobi™ (apomorphine hydrochloride sublingual film) [prescribing information]. Marlborough, Massachusetts: Sunovion Pharmaceuticals Inc.; September 2022. Available from: https://www.kynmobi.com/Kynmobi-Prescribing-Information.pdf. Accessed April 17, 2024. Nourianz™ [package insert]. Bedminster, NJ. Kyowa Kirin, Inc., May 2020. Available at: https://www.nourianz.com/assets/pdf/nourianz-full-prescribing-information.pdf. Accessed April 17, 2024. Chou KL. Clinical manifestations of Parkinson disease. UpToDate Web site. Updated March 2023. www.uptodate.com. Accessed April 17, 2024. Fox SH, Katzenschlager R, Lim SY, et al; Movement Disorder Society Evidence-Based Medicine Committee. International Parkinson and Movement Disorder Society evidence-based medicine review: update on treatments for the motor symptoms of Parkinson's disease. Mov Disord. 2018;33(8):1248-1266. Grosset DG, Dhall R, Gurevich T, et al. Long-term pulmonary safety of inhaled levodopa in Parkinson's disease subjects with motor fluctuations: a phase 3 open-label randomized study. Poster presented at: 2nd Pan American Parkinson's Disease and Movement Disorders Congress; June 22-24, 2018; Miami, FL. Jankovic J. Epidemiology, pathogenesis, and genetics of Parkinson disease. UpToDate Web site. Updated March 223. www.uptodate.com. Accessed April 17, 2024. LeWitt PA, Hauser RA, Grosset DG, et al. A randomized trial of inhaled levodopa (CVT-301) for motor fluctuations in Parkinson's disease. Mov Disord. 2016;31(9):1356-65. LeWitt PA, Hauser RA, Pahwa R, et al; on behalf of the SPAN-PD Study Investigators. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2019;18:145-54. Oertel WH, Berardelli A, Bloem BR, et al. Late (complicated) Parkinson's disease. In: Gilhus NE, Barnes MP, Brainin M, eds. European Handbook of Neurological Management. West Sussex, United Kingdom: Wiley-Blackwell; 2011:237-267. Spindler MA, Tarsy D. Initial pharmacologic treatment of Parkinson disease. UpToDate Web site. Updated March 2023. www.uptodate.com. Accessed April 17, 2024. Tarsy D. Medical management of motor fluctuations and dyskinesia in Parkinson disease. UpToDate Web site. Updated March 2023. www.uptodate.com. Accessed April 17, 2024.
| 11 | 3/14/2024 | 3/14/2025 | 7/1/2024 1:31 AM | srv_ppsgw_P | Rx.01.33 Off-Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Inbrija™ | Levodopa inhalation | | Nourianz™ | Istradefylline | | Apokyn® | Apomorphine | | Kynmobi™ | Apomorphine |
| NA | NA | | 437 | | | 10/1/2024 | Rx.01.4 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Male hypogonadism is characterized by low testosterone levels. Primary hypogonadism is characterized by low testosterone levels in the setting of elevated luteinizing hormone (LH) and follicle-stimulating hormone (FSH) concentrations. Examples of primary hypogonadism include, but are not limited to, Klinefelter syndrome, castration (physical or chemical), and trauma. Secondary hypogonadism, also referred to as hypogonadotropic hypogonadism, is characterized by low testosterone levels in the setting of normal or low LH and FSH. In this type of hypogonadism, dysfunction of the hypothalamus or pituitary is the underlying etiology. Examples of hypogonadotopic hypogonadism include, but are not limited to, idiopathic hypogonadotropic hypogonadism, Kallman syndrome, and pituitary tumors, surgery, or destruction.
Gender dysphoria, according to the World Professional Association for Transgender Health (WPATH), is defined as the discomfort arising from incongruence between an individual's gender identity and their external sexual anatomy. The standard of care for individuals affected by gender dysphoria include extensive counseling, hormonal therapy and surgery. Androgen hormone therapy is used to induce physical changes to match gender identify in transgender men (female-to-male, FTM). The goal of therapy is to maintain hormone levels in the normal physiological range for the targeted gender, to stop menses and induce virilization, including a male pattern of sexual and facial hair, change in voice, and male physical contours. Both topical and injectable testosterone products are effective for the management of gender dysphoria.
The active ingredient in all products listed is testosterone. Exogenous testosterone serves to replace testosterone in individuals who are deficient. Testosterone therapy is indicated for replacement therapy in patients with low testosterone levels due to primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). Testosterone enanthate intramuscular injection and methyltestosterone can also be used to stimulate puberty in carefully selected males with clearly delayed puberty. Methyltestosterone is also indicated for the treatment of metastasis from malignant tumor of breast in women 1 to 5 years postmenopausal with inoperable metastatic skeletal disease.
| The intent of this policy is to communicate the medical necessity criteria for Androgel®, Androderm®, Aveed®, Fortesta®, Jatenzo®, Tlando®, Natesto®, Testim®, Vogelxo®, Xyosted™, Kyzatrex®, and methyltestosterone (Methitest®) as provided under the member’s prescription drug benefit.
| Primary or secondary hypogonadism
INITIAL CRITERIA: Androgel®, Androderm®, Fortesta®, Natesto®, Testim®, Vogelxo®, Xyosted™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Aveed®), or methyltestosterone (Methitest®) is approved when ALL of the following are met: - Diagnosis of primary or secondary hypogonadism; and
- Member is 18 years of age or older; and
- ONE of the following:
- Negative history of prostate and breast cancer; or
- History of prostate cancer status post prostatectomy and documentation that the risk versus benefit has been assessed; and
- For Androgel®, Androderm®, Fortesta®, Natesto®, Testim®, Vogelxo®, Xyosted™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®), methyltestosterone (Methitest®) only, inadequate response or inability to tolerate generic transdermal testosterone; and
- For Aveed® only, inadequate response or inability to tolerate generic testosterone injection in oil formulation; and
- New users only, low (morning) testosterone level
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA Androgel®, Androderm®, Fortesta®, Natesto®, Testim®, Vogelxo®, Xyosted™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Aveed®), methyltestosterone (Methitest®) is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
_________________________________________________________________________________________
Gender dysphoria
INITIAL CRITERIA Androgel®, Androderm®, Fortesta®, Natesto®, Testim®, Vogelxo®, Xyosted™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Aveed®), or methyltestosterone (Methitest®) is approved for use as hormone therapy in children, adolescents, and adults with gender dysphoria when there is documentation of persistent, well-documented gender dysphoria diagnosed in accordance with criteria established in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA Androgel®, Androderm®, Fortesta®, Natesto®, Testim®, Vogelxo®, Xyosted™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Aveed®), methyltestosterone (Methitest®) is re-approved when there is documentation of positive clinical response to therapy. Reauthorization duration: 2 years
|
| Transdermal testosterone (Androgel®, Fortesta®, Testim®, Vogelxo®) Secondary exposure: Virilization has been reported in children who were secondarily exposed to transdermal testosterone. Ensure that children avoid contact with unwashed or unclothed application sites in men using transdermal testosterone. Advise patients to strictly adhere to recommended instructions for use. Testosterone enanthate (Xyosted™) and testosterone undecanoate capsule (Jatenzo®, Tlando®, Kyzatrex®) Blood pressure increase: - Xyosted™, Kyzatrex® and Jatenzo® can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
- Before initiating Xyosted™, Kyzatrex® and Jatenzo®, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.
- Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of Xyosted™, Kyzatrex® and Jatenzo® outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
- Due to this risk, use Xyosted™, Kyzatrex® and Jatenzo® only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies
Testosterone undecanoate (Aveed®): SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
- Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
- Following each injection of Aveed, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
- Aveed is available only through a restricted program called the Aveed REMS Program.
| | Androderm® (testosterone) [package insert]. Irvine, CA. Allergan USA, Inc. May 2020. Available from: https://www.allergan.com/assets/pdf/androderm_pi. Accessed July 31, 2024.
AndroGel® (testosterone) [package insert]. North Chicago, IL. AbbVie. November 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8677ba5b-8374-46cb-854c-403972e9ddf3&type=displayAccessed July 31, 2024.
Aveed®(testosterone undecanoate) [package insert]. Malvern, PA. Endo USA. August 2021. Available from: https://d1skd172ik98el.cloudfront.net/48a33315-f594-4269-8043-8853d10fb7bf/d793179d-9cc6-42e4-8428-05a7d7a68525/d793179d-9cc6-42e4-8428-05a7d7a68525_source__v.pdf. Accessed July 31, 2024.
Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM; Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010 Jun;95(6):2536-59.
Fortesta® (testosterone) [package insert]. Malvern, PA. Endo Pharmaceuticals, Inc. June 2020. Available from: http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=053a7300-0bce-11e0-9d16-0002a5d5c51b&type=display. Accessed July 31, 2024.
Gooren L . Hormone treatment of the adult transsexual patient. Horm Res. 2005;64(Suppl 2):31–36
Gooren LJG , Giltay EJ . Review of studies of androgen treatment of female-to-male transsexuals: effects and risks of administration of androgens to females. J Sex Med . 2008;5(4):765–776.
Jatenzo® (testosterone undecanoate) capsules [prescribing information]. Northbrook, IL. Clarus Therapeutics, Inc. January 2023. Available from: https://www.jatenzo.com/assets/pdfs/jatenzo-pi.pdf. Accessed July 31, 2024.
Kaplan AL, Trinh QD, Sun M, Carter SC, Nguyen PL, Shih YC, Marks LS, Hu JC. Testosterone replacement therapy following the diagnosis of prostate cancer: outcomes and utilization trends. J Sex Med. 2014 Apr;11(4):1063-70.
Kaufman J, Graydon RJ. Androgen replacement after curative radical prostatectomy for prostate cancer in hypogonadal men. J Urol. 2004;172(3):920-922.
Kyzatrex® (testosterone undecanoate) [prescribing information]. Raleigh, NC: Marius Pharmaceuticals LLC. September 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f7167a7-2a25-47e2-acf5-33f499fce971. Accessed July 31, 2024.
Matsumoto AM. Diagnosis and evaluation of male hypogonadism. Medscape CME. 2008. Available from: http://www.medscape.org/viewarticle/575491. Accessed July 31, 2024.
Meriggiola MC , Gava G . Endocrine care of transpeople part I. A review of cross-sex hormonal treatments, outcomes and adverse effects in transmen. Clin Endocrinol (Oxf) . 2015;83(5):597–606.
Methitest® (methyltestosterone) [prescribing information]. Bridgewater, NJ: Amneal Pharmaceuticals LLC.; October 2018. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77bb4ef4-c10e-4acc-8225-651d003f4561. Accessed July 31, 2024.
Meza J, Weaver K, Martin S. FPIN's clinical inquiries. Testosterone therapy and risk recurrence after treatment of prostate cancer. Am Fam Physician. 2013 Oct 15;88(8):Online. Available from: http://www.aafp.org/afp/2013/1015/od5.pdf
Moore E , Wisniewski A , Dobs A . Endocrine treatment of transsexual people: a review of treatment regimens, outcomes, and adverse effects. J Clin Endocrinol Metab . 2003;88(8):3467–3473.
Natesto® (testosterone) [package insert]. Malvern, PA. Endo Pharmaceuticals, Inc. October 2016. Available from: http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b0343bcc-7320-4bf2-bcb3-d95b6f4ba5fe&type=display. Accessed July 31, 2024.
Pastuszak AW, Pearlman AM, Lai WS, Godoy G, Sathyamoorthy K, Liu JS, Miles BJ, Lipshults LI, Khera M. Testosterone replacement therapy in patients with prostate cancer after radical prostatectomy. J Urol. 2013 Aug;190(2):639-44. Accessed July 31, 2024.
Seftel AD, Mack RJ, Secrest AR, et, al. Restorative increases in serum testosterone levels are significantly correlated to improvements in sexual functioning. J Androl. 2004; 25(6):963-972.
Steidle C, Schwartz S, Jacoby K, et, al. AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. J Clin Endocrinol Metab. 2003; 88(6):2673-2681.
Testim® (testosterone) [package insert]. Malvern, PA. Auxilium Pharmaceuticals. April 2018. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9f2aae1f-898d-4955-be31-678e0cf85395&type=display. Accessed July 31, 2024.
Testosterone. Micromedex. Available from: http://www.micromedexsolutions.com. Accessed July 31, 2024.
Tlando® (testosterone undecanoate) [package insert]. Ewing, NJ. Antares Pharma Inc. February 2024. Available from: https://www.tlando.com/application/files/9416/5366/3764/TLANDO_PI__Medication_Guide__FINAL__032822.pdf#hcpisi. Accessed July 31, 2024.
Vogelxo® (testosterone) [package insert]. Maple Grove, MN. Upsher-Smith Laboraories, Inc. April 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2dd150f6-cdfd-4d51-8888-12b288f26262&type=display. Accessed July 31, 2024.
Wang C, Nieschlag E, Swerdloff R, Behre HM, Hellstrom WJ, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morales A, Morley JE, Schulman C, Thompson IM, Weidner W, Wu FCW. Investigation, treatment and monitoring of late-onset hypogonadism in males. ISA, ISSAM, EAU, EAA and ASA recommendations. Eur J Endocrinol. 2008 Nov;159(5):507-514.
Xyosted™ (testosterone enanthate) injection [package insert]. Ewing, NJ. Antares Pharma, Inc. August 2023. Available at: https://www.xyosted.com/PI.pdf. Accessed July 31, 2024.
The World Professional Association for Transgender Health. Standards of Care for the Heath of Transsexual, Transgender, and Gender Nonconforming People. 7th version. 2019. Available at: https://www.wpath.org/publications/soc. Accessed July 31, 2024.
| 25 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:11 AM | srv_ppsgw_P | |
| Brand Name | Generic Name | | Androgel® | Testosterone | | Androderm® | Testosterone | | Fortesta® | Testosterone | | Natesto® | Testosterone | | Striant® | Testosterone | | Testim® | Testosterone | | Vogelxo® | Testosterone | | Aveed®, Jatenzo®, Tlando®, Kyzatrex® | Testosterone undecanoate | | Testred®, Android®, Methitest® | Methyltestosterone | | Xyosted™ | Testosterone enanthate
|
| Androgel®, Androderm®, Aveed®, Fortesta®, Jatenzo®, Tlando®, Natesto®, Testim®, Vogelxo®, Xyosted™, Kyzatrex®, Methitest® | Testosterone, Testosterone undecanoate, Methyltestosterone, Testosterone enanthate | | 438 | | | 10/1/2024 | Rx.01.213 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Mycobacterium avium complex (MAC) is the most common pulmonary nontuberculous mycobacterial (NTM) infections of the lung in almost all regions of the world. Antimycobacterial treatment is prolonged and potentially difficult to tolerate and should only be considered in individuals who meet the clinical, radiographic, and microbiologic criteria for the diagnosis of nontuberculous mycobacterial infection. Three-drug combination regimen is recommended for those treated for MAC pulmonary disease and treatment is continued until sputum cultures are consecutively negative for at least 12 months.
Amikacin liposome inhalation suspension (Arikayce®) is an aminoglycoside antibacterial indicated in adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
| The intent of this policy is to communicate the medical necessity criteria for amikacin liposome inhalation suspension (Arikayce®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Arikayce® (amikacin liposome inhalation suspension) is approved when ALL of the following are met:
- Diagnosis of refractory Mycobacterium avium complex (MAC) lung disease; and
- Member has not achieved negative sputum cultures after a minimum of 6 consecutive months of multidrug background regimen therapy; and
- Documentation that the medication will be used as part of a combination antibacterial regimen; and
- Member is 18 years of age or older; and
- Prescribed by or in consultation with a pulmonologist or infectious diseases specialist
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: Arikayce® (amikacin liposome inhalation suspension) is re-approved when both of the following are met:
- Documentation of positive clinical response to therapy; and
- Documentation that the medication will be used as part of a combination antibacterial regimen
Reauthorization duration: 12 months
| WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with a risk of increased respiratory adverse reactions, including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. | | Arikayce® (amikacin liposome inhalation suspension) [prescribing information]. Bridgewater, NJ. Insmed®. February 2023. Available at: https://www.arikayce.com/pdf/full-prescribing-information.pdf. Accessed July 31, 2024.
Kasperbauer, S. Treatment of Mycobacterium avium complex pulmonary infections in adults. UpToDate Web site. December 2023. www.uptodate.com. Accessed July 31, 2024.
| 6 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:11 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Arikayce® | Amikacin liposome inhalation suspension |
| Arikayce® | amikacin liposome inhalation suspension | | 439 | | | 10/1/2024 | Rx.01.6 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Aztreonam (Cayston®) is a monobactam antibiotic, which is part of the beta-lactam class, that binds to penicillin binding proteins of susceptible bacteria and leads to inhibition of bacterial cell wall synthesis and death of the cell.
Aztreonam (Cayston®) is indicated to improve respiratory symptoms in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa infections. Safety and effectiveness has not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
| The intent of this policy is to communicate the medical necessity criteria for aztreonam (Cayston®) as provided under the member’s prescription drug benefit.
| INITIAL CRITERIA: Aztreonam (Cayston®) is approved when ALL of the following are met:
- Member is 7 years of age or older; and
- Diagnosis of cystic fibrosis; and
- Evidence of Pseudomonas aeruginosa in the lungs confirmed by culture; and
- Susceptibility results indicating that the Pseudomonas aeruginosa is sensitive to aztreonam; and
- FEV1 that is 25% to 75% of predicted
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Aztreonam (Cayston®) is re-approved when ALL of the following are met:
- Diagnosis of cystic fibrosis; and
- Evidence of Pseudomonas aeruginosa in the lungs confirmed by culture; and
- Documentation of positive clinical response to therapy (e.g. improvement in lung function demonstrated by improved FEV1)
Reauthorization duration: 2 years
| | | Cayston® [package insert]. Foster City CA. Gilead Sciences. November 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=67300ca3-8c53-4ce4-8e86-2c03be1f9b8a&type=display. Accessed July 31, 2024.
McCoy K, Quittner A, Oermann C, et al. Inhaled Aztreonam Lysine for chronic airway pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care 2008; 178(9): 921-928. Accessed July 31, 2024.
Oermann C, Retsch-Bogart G, Quittner A, et al. An 18 month study of the safety and efficacy of repeated courses of inhaled Aztreonam Lysine in Cystic Fibosis. Pediatric Pulmonology2010; 45(11): 1121-1134. Accessed July 31, 2024.
Retsch-Bogart G, Quittner A, Gibson R, et al. Efficacy and Safety of inhaled Aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest 2009; 135(5): 1223-1232. Accessed July 31, 2024.
| 16 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:12 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Cayston® | Aztreonam |
| Cayston® | Aztreonam | | 441 | | | 10/1/2024 | Rx.01.217 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by impairment in the first branch of the trigeminal nerve which leads to a decrease in or absence of corneal sensitivity. Loss of sensitivity impairs wound healing, leading to corneal epithelial breakdown, development of ulcerations, melting of the stroma, and corneal perforation. Diagnosis, prognosis, and treatment are based on disease severity, which is classified into 3 stages. Stage 1 (mild) NK is characterized by ocular surface irregularity and reduced vision; stage 2 (moderate) is characterized by a non-healing persistent epithelial defect (PED); and stage 3 (severe) exhibits corneal ulceration involving subepithelial (stromal) tissue, which may progress to corneal melting and perforation.
Therapy for stage 1 disease aims to prevent epithelial breakdown, generally by administering preservative-free artificial tears and discontinuing all topical and systemic medications associated with ocular surface toxicity. The use of punctal plugs may also help increase tear volume. The goal of treatment for stage 2 NK is to promote healing of the epithelial defect and to avoid the development of a corneal ulcer. In addition to the therapies in the previous stage, topical antibiotics are recommended to prevent infections. Therapeutic corneal or scleral contact lenses may be used to promote healing; however, there may be an increased risk of secondary infections. Autologous serum eye drops, which contain components of natural tears, have increasingly been used to treat ocular surface disorders including NK. The main goal of treatment at stage 3 is to prevent corneal thinning and perforation. Various surgeries and procedures are available to treat ulcers not responding to medical treatment. Tarsorrhaphy is the most commonly used procedure to promote corneal healing. Alternative treatments include botulinum-induced ptosis, amniotic membrane transplantation, eyelid closure with tape, patching, and use of the conjunctival flap to cover the corneal surface.
Cenegermin-bkbj (Oxervate™) is a novel recombinant human nerve growth factor (rhNGF) produced in Escherichia coli that is structurally identical to human NGF. NGF is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity and low affinity NGF receptors in the anterior segment of the eye to support corneal innervation and integrity. Cengermin-bkbj (Oxervate™) is indicated for the treatment of neurotrophic keratitis. | The intent of this policy is to communicate the medical necessity criteria for cenegermin-bkbj (Oxervate™) as provided under the member’s prescription drug benefit.
| INITIAL CRITERIA Cenegermin-bkbj (Oxervate™) is approved when ALL of the following are met: - Diagnosis of Stage 2 or 3 neurotrophic keratitis; and
- Documentation of an inadequate response or inability to tolerate at least one over-the-counter ocular lubricant used at an optimal dose and frequency for at least two weeks (e.g., artificial tears, lubricating gels/ointments, etc.); and
- Prescribed by or in consultation with an ophthalmologist or optometrist; and
- Submission of chart documentation indicating treatment of left eye, right eye, or both; and
- Member will not exceed 8 weeks of Oxervate therapy per affected eye(s)
Initial authorization duration: 3 months
REAUTHORIZATION CRITERIA Cenegermin-bkbj (Oxervate™) is re-approved when ALL of the following are met:
- Submission of chart documentation indicating treatment of left eye, right eye, or both; and
- One of the following:
- Member has received less than or equal to 8 weeks of therapy (one course of therapy) per affected eye(s); and
- Documentation of clinical rationale for treatment greater than 8 weeks (e.g., member has a recurrence of neurotropic keratitis in the same eye, or treatment of a different eye); and
- Documentation of clinical response to prior Oxervate™ therapy; and
- Member will not exceed a total of 16 weeks of Oxervate™ therapy per affected eye(s); and
- Prescribed by or in consultation with an ophthalmologist or optometrist
Reauthorization duration: 3 months
Lifetime limit: 16 weeks of therapy per affected eye
|
| | | Bonini S, Lambiase A, Rama P, et al.; REPARO Study Group. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125(9):1332-1343. Accessed July 31, 2024.
Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2019; 66:107-131. Accessed July 31, 2024.
Oxervate® (cenegermin-bkbj) [prescribing information]. Boston, MA: Dompe U.S. Inc. October 2023. Available at: https://oxervate.com/pdf/PrescribingInformation.pdf. Accessed July 31, 2024.
Pflugfelder SC, Massaro-Giordano M, Perez VL, Hamrah P, Deng SX, Espandar L, Foster CS, Affeldt J, Seedor JA, Afshari NA, Chao W, Allegretti M, Mantelli F, Dana R. Topical Recombinant Human Nerve Growth Factor (Cenegermin) for Neurotrophic Keratopathy: A Multicenter Randomized Vehicle-Controlled Pivotal Trial. Ophthalmology. 2020 Jan;127(1):14-26. Accessed July 31, 2024.
Pocobelli A, Komaiha C, De Carlo L, Pocobelli G, Boni N, Colabelli Gisoldi RAM. Role of Topical Cenegermin in Management of a Cornea Transplant in a Functionally Monocular Patient with Neurotrophic Keratitis and Facial Nerve Palsy: A Case Report. Int Med Case Rep J. 2020 Nov 11;13:617-621. Acccessed July 31, 2024.
Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratisis. Clin Ophthalmol. 2014; 8:571-579. Accessed July 31, 2024.
Semeraro F, Forbice E, Romano V, et al. Neurotrophic keratitis. Opthalmologica. 2014;231(4):191-197. Accessed July 31, 2024.
Versura P, Giannaccare G, Pellegrini M, Sebastiani S, Campos EC. Neurotrophic keratitis: current challenges and future prospects. Eye Brain. 2018; 10:37-45. Accessed July 31, 2024.
| 9 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:12 AM | srv_ppsgw_P | Rx.01.33 Off-Label Use Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| Brand Name
| Generic Name | | Oxervate™ | cenegermin-bkbj
|
| Oxervate™ | Cenegermin-bkbj | | 443 | | | 10/1/2024 | Rx.01.134 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | The Food and Drug Administration (FDA) defines pharmacy compounding as the practice in which pharmacists combine, mix, or alter ingredients to create unique medications that meet the specific needs of an individual patient. Generally, drugs are compounded for patients that have allergic reactions to inactive ingredients in FDA approved products or for those patients who require a different formulation of a medication that is not commercially available.
Compounding pharmacies are regulated by State Boards of Pharmacy and the FDA (if they are outsourcing facilities). For non-outsourcing facilities, drugs can be compounded only if certain conditions are met, such as, valid prescription requirement for an identified individual patient; or in limited quantities before obtaining the actual prescription by the pharmacy. Moreover, FDA restricts the production of essential copies of approved and unapproved non-prescription drugs.
A compounded product is not considered medically necessary when it replicates a commercially available product (unless the commercially available product is temporarily unavailable), contains a drug product or component that has been removed from the market because it is unsafe or not effective or contains a drug product or component that is excluded from the member's benefit.
| The intent of this policy is to communicate the medical necessity criteria for compounded products, consistent with Pharmacy Compounding of Human Drug Products Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, where at least one ingredient is a prescription drug, as provided under the member's prescription drug benefit.
This policy will also be used to review requests for ingredients which are not considered standard coverage under the prescription drug benefit that are used in compounded products. This includes requests for injectable medications that are used as part of a compound for a route of administration other than injectable.
| A compounded product, including a commercially available compounding kit, is considered medically necessary when ALL of the following are met: - The active prescription ingredient(s) of the compound is FDA approved or supported by accepted compendium as stated in the Off-Label Use policy for the indication and route of administration; and
- The product as compounded is not commercially available. This may include a current short supply* of the commercially available product or the member has a medical need for a dosage form, strength or formulation other than what can be accomplished with a commercially available product; and
- Member had an inadequate response or inability to tolerate all commercially available therapeutic alternatives to treat the condition for which the compound has been requested; and
- The compound does not contain any product(s) that were withdrawn or removed from the market due to safety reasons; and
- The compound is not used for, nor does it contain, a product that is indicated for an excluded benefit (e.g., cosmetic)
Additionally, authorization may be placed to allow access to the prescription benefit for products that are not considered standard coverage (e.g. drugs administered intravenously) when all the following are met: - All of the above criteria are for medically necessary are met for the compounded product; and
- The product is being used in a compound that will be administered through a route that is considered standard coverage for the prescription benefit (e.g., oral, topical, inhalation, etc.). Bladder installation may be considered if the above criteria are met.
Authorization length for short supply of the commercially available product will be six months. All other authorizations: 2 years
* http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
* http://www.ashp.org/Drug-Shortages/Current-Shortages
| See labeling for specific ingredients used in a compound.
| | American Pharmacists Association. Frequently Asked Questions About Pharmaceutical Compounding. Available from: http://www.pharmacist.com/frequently-asked-questions-about-pharmaceutical-compounding. Accessed July 31, 2024.
ASHP Guidelines on Outsourcing Sterile Compounding Services. January 2014. Available from: http://www.ajhp.org/content/71/2/145?sso-checked=true. July 31, 2024.
International Academy of Compounding Pharmacist. Available from: http://www.iacprx.org/. Accessed July 31, 2024.
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act Guidance. July 2014. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacy-compounding-human-drug-products-under-section-503a-federal-food-drug-and-cosmetic-act. Accessed July 31, 2024.
Pharmacy Compounding of Human Drug Products Under Section 503B of the Federal Food, Drug and Cosmetic Act. January 2018. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510153.pdf. Accessed July 31, 2024.
Report: Limited FDA Survey of Compounded Drug Products. June 2018. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm, Accessed July 31, 2024.
USP Compounding Standards and Resources. Available from: http://www.usp.org/usp-healthcare-professionals/compounding?gclid=CJfWt97qmsECFedzMgodCzgA_w. Accessed July 31, 2024.
| 13 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:12 AM | srv_ppsgw_P | Off Label Use Policy (Rx.01.33)
| | Product | Description | | Compound claims greater than $75 | Compound where the submitted claim cost is greater than or equal to $75 | | Various | Compounding Kit |
| Compounded products | Compounded products | | 444 | | | 10/1/2024 | Rx.04.3 | Claim Payment Policy | Oyenusi, Oluwadamilola | Q2-2024 | Convenience packs combine two or more individual drug products into a single package. Products included in a convenience pack may include prescription products, over the counter products, and/or products not approved by the Food and Drug Administration (FDA).
| The intent of this policy is to communicate the coverage position of convenience packs.
| Coverage is subject to the terms, conditions, and limitations of the member's contract.
Convenience packs as described above are not covered under the pharmacy benefit because each product is available independently. A prescriber may issue a prescription or prescriptions for the individual components of the convenience pack. The individual components will be covered pursuant to the terms of member's benefit.
Examples of convenience packs include, but are not limited to: - DermacinRx Clorhexacin, which contains the following:
- Mupirocin 2% ointment – covered as a pharmacy benefit
- Chlorhexidine gluconate 4% solution, dimethicone 5% cream not covered (not an FDA approved product)
- Diclovix DM PAK 1.5-8% which contains the following:
- Diclofenac sodium solution 1.5% - covered as a pharmacy benefit
- Menthol gel 8% therapy pack – not covered (not FDA approved product)
| | | | 10 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:13 AM | srv_ppsgw_P | Non-FDA approved Products Rx.04.2
Off-Label Use Rx.01.33
| | Convenience packs | Convenience packs | | 445 | | | 10/1/2024 | Rx.01.263 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Vernal keratoconjunctivitis (VKC) is an allergic inflammation of conjunctiva that is bilateral and usually seasonally recurrent. There are three types of vernal conjunctivitis: palpebral (papillae primarily involving upper tarsal conjunctiva), limbal (papillae located at limbus), and mixed (components of both palpebral and limbal types). Histopathologic exam of affected conjunctiva shows small lymphoid follicles composed of increased mast cells, eosinophils, and lymphocytes, mononuclear cells and macrophages, CD4 T lymphocytes and B lymphocytes, fibroblasts, and newly secreted collagen (extracellular matrix components). As disease progresses, cellular infiltration and new collagen deposition form giant papillae (squamous epithelial hyperplasia and dense fibrous tissue containing inflammatory cells). Inflammation of limbal palisades and tarsal conjunctiva produces nodules, due to firm attachments of conjunctiva.
Cyclosporine is a calcineurin inhibitor immunosuppressant agent when administered systemically. Following ocular administration, cyclosporine is thought to act by blocking the release of pro-inflammatory cytokines such as IL-2. The exact mechanism of action in the treatment of VKC is not known.
Verkazia® ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults.
| The intent of this policy is to communicate the medical necessity criteria for cyclosporine ophthalmic emulsion (Verkazia®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Cyclosporine (Verkazia®) is approved when ALL of the following are met: - Diagnosis of moderate to severe vernal keratoconjunctivitis confirmed by the presence of clinical signs and symptoms (e.g., itching, photophobia, giant papillae at the upper tarsal conjunctiva or at the limbus, thick mucus discharge, conjunctival hyperaemia); and
- Member is 4 years of age or older; and
- Inadequate response or inability to tolerate one of the following:
- Topical ophthalmic "dual-acting" mast cell stabilizer and antihistamine (e.g., olopatadine, azelastine); or
- Topical ophthalmic mast cell stabilizers (e.g., cromolyn); and
- Inadequate response or inability to tolerate short term use (up to 2 to 3 weeks), of topical ophthalmic corticosteroids (e.g., dexamethasone, prednisolone, fluoromethalone); and
- Prescribed by or in consultation with one of the following:
- Ophthalmologist or
- Optometrist
Initial authorization duration: 6 months REAUTHORIZATION CRITERIA Cyclosporine (Verkazia®) is re-approved when there is documentation of positive clinical response to therapy as evidenced by an improvement in clinical signs and symptoms (e.g., itching, photophobia, papillary hypertrophy, mucus discharge, conjunctival hyperaemia).
Reauthorization duration: 2 years
| | | DynaMed. Vernal Keratoconjunctivitis. EBSCO Information Services. https://www.dynamed.com/condition/vernal-keratoconjunctivitis. Accessed July 31, 2024.
Verkazia® (cyclosporine) [package insert]. Emeryville, CA: Santen Incorporated; June 2022. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214965s000lbl.pdf. Accessed July 31, 2024.
| 3 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:13 AM | srv_ppsgw_P | Rx.01.33 Off Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Verkazia® | Cyclosporine ophthalmic emulsion |
| Verkazia® | Cyclosporine | | 446 | | | 10/1/2024 | Rx.01.176 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Periodic paralyses are a group of rare, inherited neuromuscular disorders, resulting from mutations in the genes that regulate muscle ion channels. These disorders are characterized by episodes of painless muscle weakness where the affected muscles become weak and unable to contract.
The two most common types of periodic paralyses are hypo- and hyper-kalemic. Hypokalemic periodic paralysis is characterized by a fall in potassium levels in the blood. In individuals with this mutation attacks often begin in adolescence and are triggered by strenuous exercise, high carbohydrate meals, or by injection of insulin, glucose, or epinephrine. Weakness may be mild and limited to certain muscle groups, or more severe and affect the arms and legs. Attacks may last for a few hours or persist for several days. Some patients may develop chronic muscle weakness later in life. Hyperkalemic periodic paralysis is characterized by a rise in potassium levels in the blood. Attacks often begin in infancy or early childhood and are precipitated by rest after exercise, fasting, cold exposure, or ingestion of small amounts of potassium. Attacks are usually shorter, more frequent, and less severe than the hypokalemic form. Muscle spasms are common. Weakness in an attack can be focal, affecting only one limb, but generalized weakness with hypotonia is more common.
Dichlorphenamide (Keveyis®, Ormalvi®) is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. The precise mechanism by which dichlorphenamide exerts its therapeutic effects in patients with periodic paralysis is unknown.
| The intent of this policy is to communicate the medical necessity criteria for dichlorphenamide (Keveyis®, Ormalvi®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Dichlorphenamide (Keveyis®, Ormalvi®) is approved when of ALL of the following are met: - Treatment of primary hyperkalemic periodic paralysis, primary hypokalemic paralysis, and related variants; and
- Prescribed by or in consultation with a neurologist; and
- No documentation of ANY of the following:
- Concomitant use of high dose aspirin; or
- Severe pulmonary disease; or
- Hepatic insufficiency; and
- Member is 18 years of age or older; and
- One of the following:
- Member has positive genetic panel for periodic paralysis; or
- One of the following tests demonstrated positive results for periodic paralysis:
- EMG/nerve conduction studies, or
- Long exercise test, or
- Muscle biopsy, or
- Muscle MRI
Initial authorization duration: 3 months CONTINUAITON CRITERIA: Dichlorphenamide (Keveyis®, Ormalvi®) is reapproved when there is documentation of positive clinical response to therapy as evidenced by a decrease in weekly attack frequency from baseline . Continuation authorization duration: 2 years
| | | Dichlorphenamide. Micromedex 2.0. Truven Health Analytics, Inc. Greenwood Village, CO. Available at: http://www.micromedexsolutions.com/. Accessed July 31, 2024.
Gutmann L, Conwit R. Hyperkalemic periodic paralysis. UpToDate. March 2024. Available at: https://www.uptodate.com/contents/hyperkalemic-periodic-paralysis. Accessed July 31, 2024.
Keveyis® (dichlorphenamide) [package insert]. Hawthorne NY. Taro Pharmaceuticals USA, Inc. January 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf. Accessed July 31, 2024.
National Institute of Neurological Disorders and Stroke (NINDS). NINDS Familial Periodic Paralyses Information Page. Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Familial-Periodic-Paralyses-Information-page. Last updated July 2024. Accessed July 31, 2024.
Ormalvi® (dichlorphenamide) [package insert]. Cambridge, United Kingdom. February 2024. Available at: https://ormalvi.com/wp-content/uploads/2024/05/ORMALVI-PI-Digital.pdf. Accessed July 31, 2024.
| 10 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:13 AM | srv_ppsgw_P | | Brand Name | Generic Name | Keveyis®, Ormalvi® | Dichlorphenamide |
| Keveyis®, Ormalvi® | Dichlorphenamide | | 447 | | | 10/1/2024 | Rx.01.166 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Droxidopa (Northera®) is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson’s disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond two weeks of treatment has not been demonstrated. The continued effectiveness of droxidopa should be assessed periodically.
The exact mechanism of action of droxidopa in the treatment of neurogenic orthostatic hypotension is unknown. Droxidopa is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa-decarboxylase, which is extensively distributed throughout the body. Droxidopa is believed to exert its pharmacological effects through norepinephrine and not through the parent molecule or other metabolites. Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction. Droxidopa in humans induces small and transient rises in plasma norepinephrine. Droxidopa is also known as L-dihydroxyphenylserine, or L-DOPS.
| The intent of this policy is to communicate the medical necessity criteria for droxidopa (Northera®) as provided under the member’s prescription drug benefit.
| INITIAL CRITERIA: Droxidopa (Northera®) is approved when ALL of the following are met: - Diagnosis of symptomatic neurogenic orthostatic hypotension; and
- Prescribed by, or in consultation with, ONE of the following:
- Cardiologist; or
- Neurologist; or
- Nephrologist; and
- Member is 18 years of age or older; and
- Attempt has been made to manage neurogenic orthostatic hypotension through at least one non-pharmacologic intervention (e.g. use of compression stockings/abdominal binder, increasing salt/fluid intake, participation in regular exercise, discontinue or reduce hypotensive or antihypertensive medications); and
- Inadequate response or inability to tolerate midodrine or fludrocortisone; and
- For the Brand Northera only, inadequate response or inability to tolerate generic droxidopa
Initial authorization duration: 1 month
REAUTHORIZATION CRITERIA: Droxidopa (Northera®) is re-approved when ALL of the following are met:
- Diagnosis of symptomatic neurogenic orthostatic hypotension; and
- For the Brand Northera only, inadequate response or inability to tolerate generic droxidopa; and
- Prescribed by, or in consultation with, ONE of the following:
- Cardiologist; or
- Neurologist; or
- Nephrologist; and
- Documentation of positive clinical response to therapy (e.g. improvement in symptoms such as orthostatic dizziness, lightheadedness, etc.)
Reauthorization duration: 12 months
| WARNING: SUPINE HYPERTENSION
Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue NORTHERA. | | Northera (droxidopa) [package insert]. Deerfield IL. Lundbeck Pharmaceutical LLC. July 2019. Available at:https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2179f02c-48d7-48eb-8007-5ae43d8d16bc&type=display . Accessed July 31, 2024.
Droxidopa. Micromedex 2.0. Truven Health Analytics, Inc. Greenwood Village, CO. Available at: http://www.micromedexsolutions.com. Accessed July 31, 2024.
Freeman R. Current pharmacologic treatment for orthostatic hypotension. Clinical Autonomic Research 2008; 18(1):14-18. Accessed July 31, 2024.
Freeman R. Neurogenic orthostatic hypotension. New England Journal of Medicine 2008; 358:615-624. Accessed July 31, 2024.
| 11 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:13 AM | srv_ppsgw_P | | Generic | Brand | Droxidopa | Northera® |
| Northera® | Droxidopa | | 448 | | | 10/1/2024 | Rx.01.221 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Commercial payers, including managed care organizations and self-funded groups, must ensure appropriate use of drugs in healthcare setting. One way to accomplish this goal is to review claims that exceed a defined threshold.
Prescription claims with a total cost exceeding $10,000 per claim reject for preliminary review at the point-of-sale with message “claim dollar amount exceeded", requiring the dispensing pharmacist to contact the pharmacy benefit manager. This will apply to any claim that exceeds $10,000, allowing them to be reviewed for clinical appropriateness prior to dispensing. For drugs not meeting approval criteria per Off-Label Use policy, the use for which the drug was prescribed would be deemed experimental/investigational.
| The intent of this policy is to communicate the medical necessity criteria for claims exceeding $10,000 as provided under the member's prescription benefit.
| Claims that exceed $10,000 are approved when the use, including indication, dose, frequency, quantity, and duration, for the requested drug is approved by the FDA or considered medically accepted per Off-Label Use policy.
Authorization duration: 2 years, or for the duration of applicable medical necessity approval (for submitted cost plus $3000)
| | | Academy of Managed Care Pharmacy® (AMCP). Where We Stand - Fraud, Waste and Abuse in Prescription Drug Benefits. Revised February 20243. Available at: https://www.amcp.org/legislative-regulatory-position/fraud-waste-and-abuse-prescription-drug-benefits. Accessed July 31, 2024.
| 6 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:13 AM | srv_ppsgw_P | Off Label Use Policy Rx.01.33 Compounded Products Rx.01.134 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit Rx.01.76
| Drug claims where total drug cost exceeds $10,000
| claims exceeding $10,000 | claims exceeding $10,000 | | 449 | | | 10/1/2024 | Rx.01.255 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Chronic kidney disease exacerbates the cardiovascular risk associated with type 2 diabetes.
Mineralocorticoid receptor overactivation is associated with kidney and cardiovascular diseases, through inflammation and fibrosis that lead to progressive kidney and cardiovascular dysfunction.
Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation. Finerenone has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.
Kerendia® (finerenone) is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
| The intent of this policy is to communicate the medical necessity criteria for finerenone (Kerendia®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Finerenone (Kerendia®) is approved when ALL of the following are met: - Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes (T2D); and
- Urine albumin-to-creatinine ratio (UACR) greater than or equal to 30 mg/g; and
- Estimated glomerular filtration rate (eGFR) greater than or equal to 25 mL/min/1.73 m2; and
- Serum potassium level less than or equal to 5.0 mEq/L prior to initiating treatment; and
- Member is 18 years of age or older; and
- One of the following:
- Minimum 30-day supply trial of a maximally tolerated dose and will continue therapy with ONE of the following:
- Generic angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril); or
- Generic angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan); or
- Sodium-glucose cotransporter-2 (SGLT2) inhibitor (e.g., Jardiance, Farxiga); or
- Member has contraindication or intolerance to ACE inhibitors, ARBs or SGLT2; and
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA Finerenone (Kerendia®) is re-approved with documentation of positive clinical response to therapy (e.g., reduced incidence of a sustained declined in eGFR, kidney failure, or renal death) Reauthorization duration: 2 years |
| | | Pitt B, Filippatos G, Agarwal R, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med. 2021;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Accessed July 31, 2024.
Kerendia® (finerenone) [package insert]. Whippany, NJ: Bayer HealthCare Pharma, Inc.; September 2022. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf. Accessed July 31, 2024.
| 4 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:14 AM | srv_ppsgw_P | | | Kerendia® | Finerenone | | 450 | | | 10/1/2024 | Rx.01.229 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | The life cycle of HIV can be broken down into 6 steps: (1) entry (binding and fusion), (2) reverse transcription, (3) integration, (4) replication (transcription and translation), (5) assembly, and (6) budding and maturation. The identification and understanding of these processes have provided the basis for antiretroviral agents used to treat HIV.
Antiretroviral agents are the standard of care for treating HIV infections. Antiretroviral therapies with different mechanism of action are usually taken in combination to suppress viral load, improve CD4 cell count, prolong survival, and reduce risk of transmitting HIV to others. Viral failure is defined as patients who had viral loads greater than 400 copies/mL and no viable antiretroviral combination therapy available due to failing at least four of six antiretroviral classes.
Fostemsavir is a prodrug without significant biochemical or antiviral activity that is hydrolyzed to the active moiety, temsavir, which is an HIV-1 attachment inhibitor. Temsavir binds directly to the gp120 subunit within the HIV-1 envelope glycoprotein gp160 and selectively inhibits the interaction between the virus and cellular CD4 receptors, thereby preventing attachment. Additionally, temsavir can inhibit gp120-dependent post-attachment steps required for viral entry into host cells
Rukobia (fostemsavir), in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Enfuvirtide is an antiretroviral drug that interferes with the entry of HIV-1 into cells by inhibiting fusion of viral and cellular membranes. Enfuvirtide binds to the first heptad-repeat (HR1) in the gp41 subunit of the viral envelope glycoprotein and prevents the conformational changes required for the fusion of viral and cellular membranes.
Fuzeon (enfuvirtide) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
| The intent of this policy is to communicate the medical necessity criteria for Rukobia® (fostemsavir) and Fuzeon® (enfuvirtide) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Fostemsavir (Rukobia®) is approved when ALL of the following are met: - Diagnosis of HIV-1; and
- Member is 18 years of age or older; and
- Will be used in combination with other antiretroviral(s); and
- Member is treatment-experienced with multi-drug resistant HIV-1 infection; and
- Member is failing their current antiretroviral regimen due to resistance, intolerance, or safety concerns.
Initial Authorization duration: 12 months CONTINUATION CRITERIA: Fostemsavir (Rukobia®) is re-approved when there is documentation of positive clinical response to therapy (e.g., decrease in viral load from baseline; HIV-1 RNA <200 copies/mL was achieved; increase in CD4+ cell count over time) Continuation authorization duration: 2 years INITIAL CRITERIA: Enfuvirtide (Fuzeon®) is approved when ALL of the following are met: - Diagnosis of HIV-1; and
- Member weighs at least 11kg; and
- Will be used in combination with other antiretroviral(s); and
- Member is treatment experienced; and
- Member is experiencing HIV-1 replication despite ongoing antiretroviral therapy
Initial authorization duration: 12 months CONTINUATION CRITERIA: Enfuvirtide (Fuzeon®) is re-approved when there is documentation of positive clinical response to therapy (e.g., decrease in viral load from baseline; HIV-1 RNA <200 copies/mL was achieved; increase in CD4+ cell count over time) Continuation authorization duration: 2 years
|
| | | Rubkobia® (fostemsavir) [package insert]. Research Triangle Park, NC: ViiV Healthcare; February 2024. Available from: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Rukobia/pdf/RUKOBIA-PI-PIL.PDF. Accessed July 31, 2024.
Henrich TJ, Kuritzkes DR. HIV-1 entry inhibitors: recent development and clinical use. Curr Opin Virol. 2013;3(1):51-57. doi:10.1016/j.coviro.2012.12.002. Accessed July 31, 2024.
Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2018–2022. HIV Surveillance Supplemental Report 2024;29(No. 1). https://stacks.cdc.gov/view/cdc/156513. Published May 2024. Accessed July 31, 2024.
Kozal M, Aberg J, Pialoux G, et al. Rostemsavir in Adults with Multidrug-Resistant HIV-1 infection, N Eng J Med. 2020 26 March; 382:1232-1243. Accessed July 31, 2024.
Rukobia (fostemsavir), Micromedex. Accessed July 31, 2024.
Fuzeon (enfuvirtide) prescribing information. South San Francisco (CA): Genentech, Inc.; December 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6935e846-d5a1-49e5-89a2-f8ebe4d5590d#S12.4. Accessed July 31, 2024.
| 6 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:14 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Rukobia® | Fostemsavir | | Fuzeon® | Enfuvirtide |
| Rukobia®, Fuzeon® | Fostemsavir, Enfuvirtide | | 451 | | | 10/1/2024 | Rx.01.174 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Heart failure affects approximately 5.1 million Americans. While survival after a diagnosis of heart failure has improved, it is still about 50% at 5 years after diagnosis. In patients with symptomatic heart failure and left ventricular ejection fraction (LVEF) < 40%, current guidelines recommend angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), beta blockers, sodium-glucose cotransporter-2 (SGLT-2), and mineralcorticoid receptor antagonist (MRA) as standard of care. With the exception of diuretics, these classes of medications decrease mortality from heart failure with reduced EF. Diuretics provide symptomatic relief, however the effects of diuretics on morbidity and mortality are not known.
Ivabradine reduces spontaneous pacemaker activity at the cardiac sinus node by blocking the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel to selectively inhibit If-current, thus reducing the heart rate. Ventricular repolarization and myocardial contractility are not affected. Increased heart rate is an ineffective compensatory mechanism and is recognized as an independent risk factor in heart failure. Corlanor® (ivabridine) is indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction and for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. Ivabradine is also indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients who are in sinus rhythm with an elevated heart rate.
Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation. Verquvo® (vericiguat) is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.
| The intent of this policy is to communicate the medical necessity criteria for Corlanor® (ivabradine) and Verquvo™ (vericiguat) as provided under the member's prescription drug benefit.
| Chronic heart failure
INITAL CRITERIA: Corlanor® (ivabradine) is approved when ALL of the following are met: - Diagnosis of stable, symptomatic chronic heart failure; and
- Member has New York Heart Association (NYHA) Class II, III, or IV symptoms; and
- Member is 18 years of age or older; and
- Left ventricular ejection fraction (LVEF) ≤ 35%; and
- Sinus rhythm with resting heart rate ≥ 70 beats per minute; and
- Member is clinically stable for at least 4 weeks on an optimized and stable clinical regimen which includes ALL of the following:
- Maximally tolerated doses of beta blockers (i.e., bisoprolol, carvedilol, metoprolol succinate ER) or inability to tolerate these beta blockers; and
- ACE inhibitors, ARBs or angiotensin receptor-neprilysin inhibitor (ARNI) (e.g., Entresto) inability to tolerate ACE inhibitor or ARB or ARNI; and
- Sodium-glucose cotransporter-2 (SGLT-2) (e.g., Jardiance, Farxiga); and
- Mineralcorticoid receptor antagonist (MRA) (e.g., spironolactone, eplerenone); and
- Prescribed by or in consultation with a cardiologist
INITIAL CRITERIA: Vericiguat (Verquvo™) is approved when ALL of the following are met: - Diagnosis of chronic heart failure; and
- Member is age 18 or older; and
- Member has an ejection fraction of less than 45 percent; and
- Member has New York Heart Association (NYHA) Class II, III or IV symptoms; and
- One of the following:
- Member was hospitalized for heart failure within the last 6 months; or
- Member used outpatient intravenous diuretics (e.g., bumetanide, furosemide) for heart failure within the last 3 months; and
- Inadequate response or inability to tolerate ALL of the following at a maximally tolerated dose:
- One of the following:
- Angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril); or
- Angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan); or
- Angiotensin receptor-neprilysin inhibitor (ARNI) [e.g., Entresto (sacubitril and valsartan)]; and
- Beta blocker (i.e.., bisoprolol, carvedilol, metoprolol succinate ER; and
- Sodium-glucose cotransporter-2 (SGLT-2) inhibitors (e.g., Jardiance, Farxiga); and
- Mineralcorticoid receptor antagonist (MRA) (e.g., spironolactone, eplerenone); and
- Prescribed by or in consultation with a cardiologist
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Vericiguat (Verquvo™) or ivabradine (Corlanor®) is re-approved when there is documentation of positive clinical response to therapy. Reauthorization duration: 2 years
_________________________________________________________________________________________
Inappropriate sinus tachycardia INITIAL CRITERIA: Ivabradine (Corlanor®) is approved when ALL of the following are met: - Diagnosis of inappropriate sinus tachycardia confirmed by both of the following:
- Sinus heart rate greater than 100 beats per minute at rest; and
- Mean 24-hour heart rate greater than 90 beats per minute; and
- Member is 18 years of age or older; and
- Documentation that other causes of sinus tachycardia have been ruled out (e.g., hyperthyroidism, anemia, illicit stimulant drug use, caffeine, etc.); and
- Inadequate response or inability to tolerate one beta-blocker; and
- Prescribed by or in consultation with a cardiologist
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA: Ivabradine (Corlanor®) is re-approved when there is documentation of positive clinical response to therapy. Reauthorization duration: 2 years
_________________________________________________________________________________________
Heart failure due to dilated cardiomyopathy INITIAL CRITERIA: Ivabradine (Corlanor®) is approved when ALL of the following are met: - Diagnosis of stable, symptomatic heart failure due to dilated cardiomyopathy; and
- Member has New York Heart Association (NYHA) Class II, III, or IV symptoms; and
- Member is 6 months of age to 18 years of age; and
- Member is in sinus rhythm; and
- Member has elevated heart rate; and
- Prescribed by or in consultation with a cardiologist; and
- Inadequate response or inability to tolerate to one of the following:
- Beta blocker (e.g., bisoprolol, metoprolol succinate extended release)
- Angiotensin-converting enzyme (ACE) inhibitor (e.g., captopril, enalapril)
- Diuretic Agent (e.g., spironolactone, furosemide)
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA: Ivabradine (Corlanor®) is re-approved when there is documentation of positive clinical response to therapy. Reauthorization duration: 2 years
|
| Vericiguat (Verquvo™): WARNING EMBRYO-FETAL TOXICITY
Do not administer VERQUVO to a pregnant female because it may cause fetal harm. Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.
| | Borer JS, Bohm M, Ford I, et al. Efficacy and safety of ivabradine in patients with severe chronic systolic heart failure (from the SHIFT study). Am J Cardiol. 2014;113:497-503. Accessed July 31, 2024.
Corlanor (ivabradine) [package insert]. Thousand Oaks, CA: Amgen, Inc. August 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=92018a65-38f6-45f7-91d4-a34921b81d0d&type=display. Accessed July 31, 2024.
Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics-2013 update: a report from the American Heart Association. Circulation. 2013. Doi: 10.1161/CIR.0b013e31828124ad. Available from: http://circ.ahajournals.org/content/127/1/e6.full.pdf+html. Accessed July 31, 2024.
Ivabradine. Micromedex. Available from: http://www.micromedexsolutions.com/. Accessed July 31, 2024.
Swedberg K, Komajda M, Bohm M, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010;376 (9744):875-85. Accessed July 31, 2024.
Yancy CW, Jessup M, Bozkurk B, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013. Doi: 10.1016/j.jacc.2013.05.020. Available from: http://circ.ahajournals.org/content/128/16/e240.full.pdf+html. Accessed July 31, 2024.
Yancy CW, Jessup M, Bozkurk B, et al.ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update to the 2013 ACC/AHA Guidelines for the Management of Heart Failure. Circulation. 2016. DOI: 10.1161/CIR.0000000000000435. Available from: http://circ.ahajournals.org/content/circulationaha/early/2016/05/18/CIR.0000000000000435.full.pdf. Accessed July 31, 2024.
Cappato R, Castelvecchio S, Ricci C, et. Al. Clinical Efficacy of Ivabradine in Patients with Inappropriate Sinus Tachycardia. Journal of the American College of Cardiology. Vol. 60, No 15, 2012. October 9, 2012: 1323-9. Accessed July 31, 2024.
Olshansky B, Sullivan R. Inappropriate Sinus Tachycardia. Journal of the American College of Cardiology. Vol. 61, No 8, 2013. February 26, 2013:793-801. Accessed July 31, 2024.
Sheldon RS, Grubb BP, Olshansky B, et. Al. 2015 Heart Rhythm Society Expert Consensus Statement on the Diagnosis and Treatment of Postural Tachycardia Syndrome, Inappropriate Sinus Tachycardia, and Vasovagal Syncope. Available at: https://www.hrsonline.org/Policy-Payment/Clinical-Guidelines-Documents/2015-HRS-Document-on-POTS-IST-VVS. Accessed July 31, 2024.
Verquvo™ (vericiguat) [prescribing information]. Whitehouse Station (NJ); Merck & Co. Inc.; July 2023. Available at: https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_pi.pdf. Accessed July 31, 2024.
| 12 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:14 AM | srv_ppsgw_P | Rx.01.33 Off-Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Corlanor® | ivabradine | | Verquvo™ | vericiguat |
| Corlanor®, Verquvo™ | ivabradine, vericiguat | | 452 | | | 10/1/2024 | Rx.01.149 | Commercial | | Q2-2024 | Hemophilia is a bleeding disorder caused by clotting factor deficiencies. Hemophilia is a rare X-linked, congenitally acquired disease that leads to a deficiency in coagulation factor, VIII (hemophilia A) or IX (hemophilia B). Hemophilia A or B occurs in approximately 1 out of 10,000 births. Hemophilia A is more common than hemophilia B, representing approximately 80-85% of hemophilia cases. The disorder is further characterized by the percentage of serum clotting factor activity as compared to the normal range:
- Severe hemophilia: clotting factor levels are less than 1% of normal
- Moderate hemophilia: clotting factor levels are 1-5% of normal
- Mild hemophilia: clotting factors are 5-40% of normal
Treatment of hemophilia generally involves an infusion of the deficient factors to allow for more normalized clotting response and decreased incidence of uncontrolled bleeding events. Treatment regimens are individualized based on disease severity and may include prophylactic infusions of clotting factors, on demand infusions of clotting factors, or a combination of both. Perioperative infusions are also part of the treatment regimen. While Hemophilia A and hemophilia B are the most common types of hemophilia, 1 in every 500,000 to 2 million people have coagulation disorders caused by deficiencies in clotting factors other than factor VIII or IX. The products listed below include those with indications to treat these rare forms of coagulation disorders. | Drug | Factor | Hemophilia A | Hemophilia B | Acquired hemophilia | Von Willebrand disease | Congenital fibrinogen deficiency | Hereditary factor X deficiency | Congenital factor XIII deficiency | Control of bleeding episodes, on demand | Perioperative management | Routine prophylaxis | | Advate® | Recombinant factor VIII | X | | | | | | | X | X | X | | Adynovate® | Recombinant factor VIII, PEGylated | X | | | | | | | X | X | X | | Afstyla® | Recombinant Factor VIII | X | | | | | | | X | X | X | | Alphanate® | Factor VIII/ von Willebrand factor complex, human | X | | | X (in certain circumstances) | | | | X | X | X | | Alphanine SD® | Factor IX, human | | X | | | | | | X | X | X | | Alprolix® | Recombinant factor IX, Fc fusion protein | | X | | | | | | X | X | X | | Altuviiio™ | Recombinant Fc-VWF-XTEN fusion protein-ehtl | X | | | | | | | X | X | X | | Benefix® | Factor IX, recombinant | | X | | | | | | X | X | X | | Coagadex® | Factor X, human | | | | | | X | | X | X | | | Corifact® | Factor XIII concentrate, human | | | | | | | X | | X | X | | Eloctate® | Recombinant factor VIII, Fc fusion protein | X | | | | | | | X | X | X | | Esperoct® | Recombinant, glycopegylated-exei | X | | | | | | | X | X | X | | Feiba [NF] ® | Anti-inhibitor coagulant complex | X (with inhibitors) | X (with inhibitors) | | | | | | X | X | X | | Hemlibra® | Factor IXa/ factor X, directed antibody | X | | | | | | | | | X | | Hemofil M® | Factor VIII, human | X | | | | | | | X | X | X | | Humate P® | Factor VIII/ von Willebrand factor complex, human | X | | | X (in certain circumstances) | | | | X | X | X | | Idelvion® | Factor IX, recombinant albumin fusion protein | | X | | | | | | X | X | X | | Ixinity® | Factor IX, recombinant | | X | | | | | | X | X | X | | Jivi® | Recombinant, PEGylated, Factor VIII | X | | | | | | | X | X | X | | Koate DVI® | Factor VIII, human | X | | | | | | | X | X | X | | Kogenate FS® | Recombinant factor VIII | X | | | | | | | X | X | X | | Kovaltry® | Recombinant factor VIII | X | | | | | | | X | X | X | | Novoeight® | Recombinant factor VIII | X | | | | | | | X | X | X | | Novoseven RT® | Recombinant factor VIIa | X | X | X | | | | | X | X | | | Nuwiq® | Recombinant factor VIII | X | | | | | | | X | X | X | | Obizur® | Recombinant factor VIII, porcine sequence | | | X | | | | | X | | | | Profilnine® | Factor IX, human | | X | | | | | | X | | X | | Rebinyn® | Recombinant Factor IX | | X | | | | | | X | X | | | Recombinate® | Recombinant factor VIII | X | | | | | | | X | X | X | | Riastap® | Fibrinogen concentrate, human | | | | | X | | | X | | | | Rixubis® | Factor IX, recombinant | | X | | | | | | X | X | X | | Sevenfact® | Factor VIIa, recombinant | X | X | | | | | | | | | | Tretten® | Factor XIII A subunit, recombinant | | | | | | | X (A subunit) | | | X | | Vonvendi® | Von Willebrand Factor Recombinant | | | | X | | | | X | | | | Wilate® | von Willebrand/ factor VIII complex, human | | | | X | | | | X | | | | Xyntha® [Solufuse] | Recombinant factor VIII | X | | | | | | | X | X | X
|
| The intent of this policy is to communicate the medical necessity criteria for Advate®, Adynovate®, Afstyla®, Alphanate®, Alphanine SD®, Alprolix®, Altuviiio™, Benefix®, Coagadex®, Corifact®, Eloctate®, Esperoct®, Feiba NF®, Hemlibra®, Hemofil M®, Humate P®, Idelvion®, Ixinity®, Jivi®, Koate DVI®, Kogenate FS®, Kovaltry®, Novoeight®, Novoseven RT®, Nuwiq®, Obizur®, Profilnine®, Rebinyn®, Recombinate®, Riastap®, Rixubis®, Sevenfact®, Tretten®, Vonvendi®, Wilate®, and Xyntha®/Xyntha® SolofuseTM as provided under the member's prescription drug benefit.
| Advate®, Adynovate®, Afstyla®, Alphanate®, Alphanine SD®, Alprolix®, Altuviiio™, Benefix®, Coagadex®, Corifact®, Eloctate®, Esperoct®, Feiba NF®, Hemlibra®, Hemofil M®, Humate P®, Idelvion®, Ixinity®, Jivi®, Koate DVI®, Kogenate FS®, Kovaltry®, Novoeight®, Novoseven RT®,Nuwiq®, Obizur®, Profilnine®, Rebinyn®, Recombinate®, Riastap®, Rixubis®, Sevenfact®, Tretten®, Vonvendi®, Wilate®, Xyntha®/Xyntha® Solofuse are approved when there is a diagnosis of an FDA approved indication Approval duration: 2 years
| Feiba® NF Thrombotic/Thromboembolic events: Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of anti-inhibitor coagulant complex, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving anti-inhibitor coagulant complex for signs and symptoms of thromboembolic events.
Hemlibra®
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.
Novoseven®, Sevenfact®
Serious arterial and venous thrombotic events following administration of Novoseven and Sevenfact RT have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive Novoseven and Sevenfact RT. Monitor patients for signs and symptoms of activation of the coagulation system and for thrombosis. | | | 23 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:14 AM | srv_ppsgw_P | | | | | | 453 | | | 10/1/2024 | Rx.01.100 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | In the United States, it is estimated that 2.7 to 3.9 million people are chronically infected with HCV. Chronic HCV infection occurs after acute infection with the virus. It is estimated that approximately 75%-85% of acute infections become chronic. The remaining 15%-25% clear the virus without treatment and do not develop chronic HCV. Genotype (GT) 1 is the most prevalent, with the breakdown as follows: GT 1a: 46.2%, GT1b: 26.3%, GT2: 10.7%, GT3: 8.9%, GT4: 6.3%, GT6: 1.1%, mixed GT/ other: 0.5%.
The goal of treating chronic HCV is to "reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a sustained virologic response (SVR)." SVR is defined as the "continued absence of detectable HCV RNA at least 12 weeks after completion of therapy" and is considered a marker for cure of HCV. Several benefits are associated with HCV cure, including decreases in liver inflammation, progression to liver fibrosis, hepatocellular carcinoma, liver-related mortality and liver transplantation.
This policy follows the AASLD/IDSA guidelines. Current treatment regimens consist of at least 2 agents. Monotherapy is not recommended.
Elbasvir/ grazeprevir (Zepatier®) is a product containing an HCV NS5A inhibitor (elbasvir) and an HCV NS3/4A protease inhibitor in a fixed dose combination.
Glecaprevir/pibrentasvir (Mavyret™) is a fixed-dose combination of glecaprevir, an HCV NS2/4A inhibitor, and pibrentasvir, an HCV NS5A inhibitor.
Ledipasvir/ sofosbuvir (Harvoni®) is a combination product that contains an HCV NS5A replication inhibitor (ledipasvir) and an HCV NS5B RNA-dependent polymerase inhibitor (sofosbuvir) in a fixed dose combination.
Ombitasvir/ paritaprevir/ ritonavir and dasabuvir (Viekira Pak®) is a combination product that contains an HCV NS5A replication inhibitor (ombitasivir), an HCV NS3/4A protease inhibitor (parataprevir) and a booster (ritonavir) as a fixed dose tablet along with an HCV NS5B RNA-dependent RNA polymerase inhibitor (dasabuvir) as a separate tablet.
Sofosbuvir (Sovaldi®) inhibits HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) is a fixed-dose combination of sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor; velpatasvir, an HCV NS5A inhibitor; and voxilaprevir, an HCV NS3/4A protease inhibitor.
Velpatisvir/ sofosbuvir (Epclusa®) is a combination product that contains an HCV NS5A replication inhibitor (velpatisvir) and an HCV NS5B RNA-dependent polymerase inhibitor (sofosbuvir) in a fixed dose combination.
| The intent of this policy is to communicate the medical necessity criteria for elbasvir/ grazeprevir (Zepatier®), ledipasvir/ sofosbuvir (Harvoni®), ombitasvir/ paritaprevir/ ritonavir and dasabuvir (Viekira Pak®), sofosbuvir (Sovaldi®), velpatasvir/ sofosbuvir (Epclusa®), glecaprevir/pibrentasvir (Mavyret™), and sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) as provided under the member’s prescription drug benefit.
| TREATMENT NAIVE A. Genotype 1 Mavyret™ is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 56 days (8 weeks)
Velpatasvir/ sofosbuvir (Epclusa®) is approved when ALL of the following are met:
- Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Approved length of therapy: 84 days (12 weeks)*; and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only), details of intolerability must be provided
Ledipasvir/ sofosbuvir (Harvoni®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Approved length of therapy: 84 days (12 weeks)*; and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details of intolerability must be provided
Zepatier® is approved when ALL of the following are met: - Age 12 years or older or weighing at least 30kg; and
- Diagnosis of HCV genotype 1; and
- Results of testing for baseline high fold-change NS5A resistance-associated variant are provided (for genotype 1a); and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Documentation of a dispensed prescription for and inability to tolerate glecaprevir/pibrentasvir (Mavyret™), brand Harvoni® or brand Epclusa®, details of intolerability must be provided; and
- Used concurrently with ribavirin for genotype 1a when baseline high fold-change NS5A resistance-associated variant are detected; and
- Approved length of therapy:
- Genotype 1a without baseline high fold-change NS5A resistance-associated variant or genotype 1b: 84 days (12 weeks)*
- Genotype 1a with baseline high fold-change NS5A resistance-associated variant: 112 days (16 weeks)*
Viekira Pak® is approved when ALL of the following are met: - Age 18 years or older; and
- Diagnosis of chronic HCV genotype 1; and
- ONE of the following:
- Genotype 1a without cirrhosis; or
- Genotype 1b with absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Documentation of a dispensed prescription for and inability to tolerate glecaprevir/ pibrentasvir (Mavyret™), brand Harvoni® or brand Epclusa®, details of intolerability must be provided; and
- Used concurrently with ribavirin for genotype 1a; and
- Approved length of therapy: 84 days (12 weeks) *
B. Genotype 2
Mavyret™ is approved when all of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 2; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 56 days (8 weeks)*
Velpatasvir/ sofosbuvir (Epclusa®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 2; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only), details of intolerability must be provided.; and
- Approved length of therapy: 84 days (12 weeks)*
C. Genotype 3
Mavyret™ is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 3; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 56 days (8 weeks)*
Velpatasvir/ sofosbuvir (Epclusa®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 3; and
- Absence of decompensated cirrhosis (i.e. compensated cirrhosis or no cirrhosis); and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only), details of intolerability must be provided.; and
- Concurrent use of ribavirin if compensated cirrhosis and Y93H substitution present; and
- Approved length of therapy: 84 days (12 weeks)
Vosevi® is approved when ALL of the following are met: - Age 18 years or older; and
- Diagnosis of chronic HCV genotype 3; and
- Compensated cirrhosis; and
- Presence of Y93H; and
- Approved length of therapy: 84 days (12 weeks)*
D. Genotype 4 Mavyret™ is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 4; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 56 days (8 weeks)
Velpatasvir/ sofosbuvir (Epclusa®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 4; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
Ledipasvir/ sofosbuvir (Harvoni®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 4; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
Zepatier® is approved when ALL of the following are met: - Age 12 years or older or weighing at least 30kg; and
- Diagnosis of chronic HCV genotype 4; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Documentation of a dispensed prescription for and inability to tolerate glecaprevir/ pibrentasvir (Mavyret™), brand Harvoni® or brand Epclusa®, details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
E. Genotype 5 or 6
Mavyret™ is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 5 or 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 56 days (8 weeks)
Velpatasvir/ sofosbuvir (Epclusa®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 5 or 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
Ledipasvir/ sofosbuvir (Harvoni®) is approved when ALL the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 5 or 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
RETREATMENT (note: Retreatment for interferon or interferon plus first generation protease inhibitor failures should be treated as treatment naïve) Sofosbuvir-Based and Elbasvir/Grazoprevir Treatment Failures A. Genotype 1, 2, 4, 5 and 6 Mavyret™ is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 4, 5, 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Member failed Sofosbuvir-Based therapy or Zepatier (Elbasvir/Grazoprevir); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 112 days (16 weeks)
Vosevi® is approved when ALL the following are met: - Age 18 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 4, 5, 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Member failed Sofosbuvir-Based therapy or Zepatier (Elbasvir/Grazoprevir); and
- Approved length of therapy: 84 days (12 weeks)*
B. Genotype 3 Vosevi® is approved when ALL the following are met: - Age 18 years or older; and
- Diagnosis of chronic HCV genotype 3 and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Member failed Sofosbuvir-Based therapy or Zepatier (Elbasvir/Grazoprevir); and
- Approved length of therapy: 84 days (12 weeks)*
Glecaprevir/Pibrentasvir Treatment Failures A. Genotype 1, 2, 3, 4, 5, 6 Mavyret™ and Sovaldi® is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 3, 4, 5, 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Member failed Mavyret (Glecaprevir/Pibrentasvir); and
- Concurrent use of ribavirin; and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 112 days (16 weeks)
Vosevi® is approved when ALL the following are met: - Age 18 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 3, 4, 5, 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis) ; and
- Member failed Mavyret (Glecaprevir/Pibrentasvir); and
- Approved length of therapy: 84 days (12 weeks)
Multiple DAA Treatment Failures (All Genotypes), Including Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) or Sofosbuvir Plus Mavyret™ (Glecaprevir/Pibrentasvir) A. Genotypes 1, 2, 4, 5, 6 Mavyret™ and Sovaldi is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 4, 5, 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Member failed Mavyret (Glecaprevir/Pibrentasvir) and Sovaldi (sofosbuvir) or Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir); and
- Concurrent use of ribavirin; and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 112 days (16 weeks)
Vosevi® is approved when ALL the following are met: - Age 18 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 4, 5, 6; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Member failed Mavyret (Glecaprevir/Pibrentasvir) and Sovaldi (sofosbuvir) or Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir; and
- Concurrent use of ribavirin (for members with compensated cirrhosis); and
- Approved length of therapy: 168 days (24 weeks)
B. Genotype 3 Mavyret™ and Sovaldi is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 3; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Member failed Mavyret (Glecaprevir/Pibrentasvir) and Sovaldi (sofosbuvir) or Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir); and
- Concurrent use of ribavirin; and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy:
- NO cirrhosis - 112 days (16 weeks)
- Compensated cirrhosis up to 168 days (24 weeks)
Vosevi® is approved when ALL the following are met: - Age 18 years or older; and
- Diagnosis of chronic HCV genotype 3 and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis) ; and
- Member failed Mavyret (Glecaprevir/Pibrentasvir) and Sovaldi (sofosbuvir) or Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir); and
- Concurrent use of ribavirin (for members with compensated cirrhosis); and
- Approved length of therapy: 168 days (24 weeks)
DECOMPENSATED CIRRHOSIS (moderate to severe hepatic impairment; Child Turcotte Pugh B or C)
A. Treatment Naive
Ledipasvir/ sofosbuvir (Harvoni®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1, 4, 5, or 6; and
- Documentation of decompensated cirrhosis (defined as Child Turcotte Pugh class B or C) or hepatocellular carcinoma; and
- One of the following:
- Concurrent use of ribavirin; or
- Member is unable to tolerate ribavirin; and
- Prescribed by a hepatitis C expert (i.e., hepatologist, liver transplant surgeon) ; and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details or intolerability must be provided; and
- Approved length of therapy:
- Without ribavirin: 168 days (24 weeks)*; or
- With ribavirin: 84 days (12 weeks)*
Velpatasvir/sofosbuvir (Epclusa®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 3, 4, 5, or 6; and
- Documentation of decompensated cirrhosis (defined as Child Turcotte Pugh class B or C) or hepatocellular carcinoma; and
- One of the following:
- Concurrent use of ribavirin; or
- Member is unable to tolerate ribavirin; and
- Prescribed by a hepatitis C expert (i.e., hepatologist, liver transplant surgeon) ; and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy:
- With ribavirin: 168 days (24 weeks)*; or
- Without ribavirin: 168 days (24 weeks)*
B. Retreatment with Prior Sofosbuvir or NS5A inhibitor-base treatment Ledipasvir/ sofosbuvir (Harvoni®) is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1, 4, 5, or 6; and
- Documentation of decompensated cirrhosis (defined as Child Turcotte Pugh class B or C) or hepatocellular carcinoma; and
- Prescribed by a hepatitis C expert (i.e., hepatologist, liver transplant surgeon); and
- Concurrent use of ribavirin; and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details or intolerability must be provided; and
- Approved length of therapy: 168 days (24 weeks)*
Velpatasvir/sofosbuvir (Epclusa®) is approved when ALL of the following are met:
- Age 3 years or older; and
- Diagnosis of chronic HCV genotype 1, 2, 3, 4, 5, or 6; and
- Documentation of decompensated cirrhosis (defined as Child Turcotte Pugh class B or C) or hepatocellular carcinoma; and
- Prescribed by a hepatitis C expert (i.e., hepatologist, liver transplant surgeon) ; and
- Concurrent use of ribavirin; and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only) details of intolerability must be provided; and
- Approved length of therapy: 168 days (24 weeks)*
RECURRENT HCV POST LIVER TRANSPLANT
Genotype 1 Mavyret™ is approved when there is documentation of ALL of the following: - Age 3 years or older; and
- Diagnosis of HCV genotype 1; and
- Documentation of liver transplant; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 84 days (12 weeks)*
Ledipasvir/ sofosbuvir (Harvoni®) is approved when there is documentation of ALL of the following: - Age 3 years or older; and
- Diagnosis of HCV genotype 1; and
- Documentation of liver transplant; and
- Used with ribavirin; and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
Viekira Pak® is approved when ALL of the following are met: - Age 18 years or older; and
- Diagnosis of HCV genotype 1; and
- Documentation of liver transplant; and
- Documentation of normal hepatic function; and
- Documentation of mild fibrosis; and
- Used with ribavirin; and
- Documentation of a dispensed prescription for and inability to tolerate glecaprevir/ pibrentasvir (Mavyret™) or brand Harvoni®, details of intolerability must be provided; and
- Approval length: 24 weeks
B. Genotype 2 or 3
Mavyret™ is approved when ALL of the following are met: - Age 3 years or older; and
- Diagnosis of HCV genotype 2 or 3; and
- Documentation of liver transplant; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 84 days (12 weeks)*
Velpatasvir/ sofosbuvir (Epclusa®) is approved when ALL the following are met: - Age 3 years or older; and
- Diagnosis of HCV genotype 2 or 3; and
- Documentation of liver transplant; and
- Used with ribavirin; and
- Presence of cirrhosis; and
- Inadequate response or inability to tolerate brand Epclusa® (applies to velpatasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
C. Genotype 4, 5 or 6 Mavyret™ is approved when there is documentation of ALL of the following: - Age 3 years or older; and
- Diagnosis of HCV genotype 4, 5, or 6; and
- Documentation of liver transplant; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 84 days (12 weeks)*
Ledipasvir/ sofosbuvir (Harvoni®) is approved when there is documentation of ALL of the following:
- Age 3 years or older; and
- Diagnosis of HCV genotype 4, 5, or 6; and
- Documentation of liver transplant; and
- Used with ribavirin; and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
KIDNEY TRANSPLANT RECIPIENT
A. Genotype 1 or 4
Mavyret™ is approved when there is documentation of ALL of the following: - Age 3 years or older ; and
- Diagnosis of HCV genotype 1 or 4; and
- Documentation of kidney transplant; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 84 days (12 weeks)*
Ledipasvir/ sofosbuvir (Harvoni®) is approved when there is documentation of ALL of the following: - Age 3 years or older; and
- Diagnosis of HCV genotype 1 or 4; and
- Documentation of kidney transplant; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Inadequate response or inability to tolerate brand Harvoni® (applies to ledipasvir/sofosbuvir only), details of intolerability must be provided; and
- Approved length of therapy: 84 days (12 weeks)*
B. Genotype 2,3,5, or 6
Mavyret™ is approved when there is documentation of ALL of the following: - Age 3 years or older; and
- Diagnosis of HCV genotype 2,3,5, or 6; and
- Documentation of kidney transplant; and
- Absence of decompensated cirrhosis (i.e., compensated cirrhosis or no cirrhosis); and
- Not used in combination with another HCV direct acting antiviral agent; and
- Approved length of therapy: 84 days (12 weeks)*
*Approved length of therapy: if therapy was initiated prior to coverage with the plan, authorization will only be granted to allow completion of the specified therapy. Authorizations will end 180 days after receipt of request.
Maximum doses per day apply | Drug | Maximum dose per day (tablets) | | velpatasvir/ sofosbuvir (Epclusa®) | 1 | | velpatasvir/ sofosbuvir (Epclusa®) pack 200-50mg | 2 | | velpatasvir/ sofosbuvir (Epclusa®) pack 150-37.5mg | 1 | | Mavyret™ | 3 | | Mavyret™ pak 50-20mg | 5 | | Ledipasvir/sofosbuvir (Harvoni®) | 1
| | Sovaldi® | 1 | | Viekira Pak® | 6 | | Zepatier® | 1 | | Vosevi® | 1 |
HCV Treatment Regimens that are not recommended and considered not medically necessary - Sofosbuvir with ribavirin x 24 weeks (except in genotype 2 post liver transplant)
- Peg-interferon and ribavirin with or without sofosbuvir, simeprevir, telaprevir, or boceprevir)
- Monotherapy with peg-interferon, ribavirin, or a direct-acting antiviral
- Simeprevir, paritaprevir, or elbasvir/grazoprevir based regimens in those decompensated cirrhosis
| Epclusa® (velpatasvir/sofosbuvir), Sovaldi® (sofosbuvir), Viekira Pak® (ombitasvir/paritaprevir/ritonavir/dasabuvir), Harvoni® (ledipasvir/sofosbuvir), Zepatier® (elbasvir/grazoprevir), Mavyret™ (glecaprevir and pivrentasvir) & Vosevi® (sofosbuvir/velpatasvir/voxilaprevir):
RISK OF HEPATITIS B REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
| | American Association for the Study of Liver Disease, Infectious Diseases Society or America, International Antiviral Society-USA. Recommendations for testing, managing and treating Hepatitis C. Available from https://www.hcvguidelines.org/. Accessed July 31, 2024.
Epclusa® (velpatasvir/sofosbuvir) [package insert]. Forest City, CA: Gilead Sciences, Inc; May, 2022. Available from: https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf. Accessed July 31, 2024.
Harvoni® (ledipasvir/sofosbuvir) [package insert]. Forest City, CA: Gilead Sciences, Inc; March 2020. Available from: https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf. Accessed July 31, 2024.
Hepatitis C Information for Health Professionals. Centers for Disease Control and Prevention. July 2019. Available from: http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm. Accessed July 31, 2024.
Mavyret™ (glecaprevir/pibrentasvir) [package insert]. North Chicago, IL: AbbVie, Inc.; June 2021. Available from https://www.rxabbvie.com/pdf/mavyret_pi.pdf. Accessed July 31, 2024.
Sovaldi® (sofosbuvir) [package insert]. Forest City, CA: Gilead Sciences, Inc; April 2021. Available from: https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf?evo_source=SOVALDI. Accessed July 31, 2024.
Viekira Pak® (ombitasvir/ paritaprevir/ ritonavir and dasabuvir) [package insert]. North Chicago, IL: AbbVie, Inc; Nov 2020. Available from: https://www.rxabbvie.com/pdf/viekirapak_pi.pdf. Accessed July 31, 2024.
Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir) [package insert]. Foster City, CA: Gilead Sciences, Inc.; November 2019. Available from: http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/vosevi/vosevi_pi.pdf. Accessed July 31, 2024.
Zepatier® (elbasvir/ grazeprovir) [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; May 2022. Available from: https://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf. Accessed July 31, 2024.
| 29 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:14 AM | srv_ppsgw_P | Off-label Drug Use Rx.01.33
| | Brand Name | Generic Name | | Epclusa® | velpatasvir/ sofosbuvir | | Harvoni® | ledipasvir/ sofosbuvir | Viekira Pak®
| ombitasvir/ paritaprevir/ ritonavir and dasabuvir | Sovaldi®
| sofosbuvir | Zepatier®
| elbasvir/grazoprevir | MavyretTM
| glecaprevir/pibrentasvir
|
| Zepatier®, Harvoni®, Viekira Pak®, Sovaldi®, Epclusa®, Mavyret™, Vosevi® | elbasvir/ grazeprevir, ledipasvir/ sofosbuvir, ombitasvir/ paritaprevir/ ritonavir and dasabuvir, sofosbuvir, velpatasvir/ sofosbuvir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir | | 454 | | | 10/1/2024 | Rx.01.109 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of angioedema. The most frequently implicated areas during an attack of HAE include areas of the skin, gastrointestinal tract, and upper respiratory tract, including the larynx. Involvement of the larynx may lead to fatality by asphyxiation. During episodes of HAE, individuals experience severe edema of the affected areas, characterized by gradual worsening over 24 hours and resolution within 2-5 days without treatment. Importantly, symptoms of HAE exclude urticaria and pruritis. Several forms of hereditary angioedema exist, with type I and II being most common. In most cases, individuals with HAE demonstrate a deficiency in C1 inhibitor caused by mutation in the C1 inhibitor gene. . Neither anabolic steroids nor antifibrinolytic drugs, used for prophylaxis of HAE attacks, are reliably effective in treating acute HAE attacks. Epinephrine, corticosteroids, and antihistamines are also not effective for treating HAE attacks and are not recommended by current guidelines. Guidelines recommend that patients with HAE have access to an "effective, on-demand, HAE-specific agent" to manage acute attacks. Mechanism of Action Vasodilation results from excessive bradykinin production, a downstream effect from a deficiency in C1 (a subset of Complement protein) inhibitor protein. C1-inhibitor protein inhibits kallikrein, which is a protease that activates the potent vasodilator, bradykinin. Modulation of the C1 cascade is a target for the prophylaxis and treatment of acute attacks of HAE. Patients with HAE have low levels of endogenous or functional C1 esterase inhibitor (C1INH). Although the events that induce attacks of angioedema in HAE patients are not well understood, it is thought that contact system activation occurs. Contact system activation results in increased levels of bradykinin which causes increases in vascular permeability which results in the clinical manifestations of HAE. Sajazir™/Firazyr® (icatibant) inhibits bradykinin from binding the B2 receptor and thereby treats the clinical symptoms of an acute, episodic attack of hereditary angioedema. Icatibant is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Haegarda® (C1 esterase inhibitor subcutaneous [human]) is a plasma-derived concentrate of C1 esterase inhibitor (human) that is indicated for routine prophylaxis to prevent HAE attacks in patients 6 years of age and older. Cinryze® (C1 esterase inhibitor [human]) is C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in pediatric (6 years old and above), adolescent and adult patients with HAE. Berinert® (C1 esterase inhibitor [human] is a plasma-derived C1 esterase inhibitor (human) indicated for the treatment of acute abdominal, facial, or laryngeal HAE attacks in adult and pediatric patients. Orladeyo™ (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. Ruconest® is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adults and adolescent patients with HAE. Takhzyro® (lanadelumab-flyo) is a human monoclonal antibody that acts to inhibit plasma kallikrein, and is indicated for prevention of HAE in patients 2 years of age and older. Kallikrein is a protease that activates bradykinin, a potent vasodilator implicated in the pathogenesis of angioedema attacks in patients with HAE. Inhibition of kallikrein results in downstream inhibition of bradykinin production.
| The intent of this policy is to communicate the medical necessity criteria for Takhzyro® (lanadelumab-flyo), Haegarda® (C1 esterase inhibitor subcutaneous [human]), Cinryze® (C1 esterase inhibitor [human]), Berinert® (C1 esterase inhibitor [human]), Ruconest® (C1 inhibitor recombinant), Sajazir™/Firazyr® (icatibant), and Orladeyo™ (berotralstat) as provided under the member's pharmacy benefit.
| Prophylaxis against angioedema attacks INITIAL CRITERIA: C1 esterase inhibitor (human) (Cinryze® or Haegarda®) is approved when ALL of the following are met: - Diagnosis of hereditary angioedema (HAE); and
- One of the following:
- Diagnosis has been confirmed by C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following:
i. C1-INH antigenic level below the lower limit of normal; or ii. C1-INH functional level below the lower limit of normal; or - Diagnosis has been confirmed by both of the following:
i. Member has normal C1-INH level (HAE-n1-C1INH previously referred to as HAE Type 3); and ii. One of the following: - Confirmed presence of a FXII, plasminogen gene mutation, angiopoietin-1 mutation, or kininogen mutation; or
- Member has recurrent angioedema attacks that are refractory to high-dose antihistamines (e.g., cetirizine) with a confirmed family history of recurrent angioedema; and
- Prescribed by or in consultation with an immunologist, allergist, or pulmonologist; and
- Member is 6 years of age or greater; and
- For prophylaxis against HAE attacks; and
- For Cinryze only, inadequate response or inability to tolerate ONE of the following:
- Haegarda; or
- Takhzyro; or
- Orladeyo
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA CI esterase inhibitors (human) (Cinryze® or Haegarda®) is re-approved with documentation of positive clinical response to therapy. Reauthorization duration: 2 years
INITIAL CRITERIA: Lanadelumab-flyo (Takhzyro®) injection or berotralstat (Orladeyo®) is approved when all of the following are met:
- Diagnosis of hereditary angioedema (HAE); and
- One of the following:
- Diagnosis has been confirmed by C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following:
i. C1-INH antigenic level below the lower limit of normal; or ii. C1-INH functional level below the lower limit of normal; or - Diagnosis has been confirmed by both of the following:
i. Member has normal C1-INH level (HAE-n1-C1INH previously referred to as HAE Type 3); and ii. One of the following: - Confirmed presence of a FXII, plasminogen gene mutation, angiopoietin-1 mutation, or kininogen mutation; or
- Member has recurrent angioedema attacks that are refractory to high-dose antihistamines (e.g., cetirizine) with a confirmed family history of recurrent angioedema; and
- For prophylaxis against HAE attacks; and
- One of the following:
- For Takhzyro, member is 2 years of age or older; or
- For Orladeyo, member is 12 years of age or older; and
- Prescribed by or in consultation with an immunologist, allergist, or pulmonologist
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Lanadelumab-flyo (Takhzyro®), or berotralstat (Orladeyo®) is re-approved with documentation of positive clinical response to therapy. Reauthorization duration: 2 years __________________________________________________________________________________________ Treatment of angioedema attacks
INITIAL CRITERIA: C1 esterase inhibitor (human) (Berinert®) is approved when ALL of the following are met:
- Diagnosis of hereditary angioedema (HAE); and
- One of the following:
- Diagnosis has been confirmed by C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following:
i. C1-INH antigenic level below the lower limit of normal; or ii. C1-INH functional level below the lower limit of normal; or - Diagnosis has been confirmed by both of the following:
i. Member has normal C1-INH level (HAE-n1-C1INH previously referred to as HAE Type 3); and ii. One of the following: - Confirmed presence of a FXII, plasminogen gene mutation, angiopoietin-1 mutation, or kininogen mutation; or
- Member has recurrent angioedema attacks that are refractory to high-dose antihistamines (e.g., cetirizine) with a confirmed family history of recurrent angioedema; and
- Prescribed by or in consultation with an immunologist, allergist, or pulmonologist; and
- For the treatment of acute abdominal, facial, or laryngeal HAE attacks; and
- One of the following:
- Inadequate response or inability to tolerate C1 esterase inhibitor recombinant (Ruconest®); or
- One of the following:
i. Member is 12 years of age or younger; or ii. Documentation that member has history of laryngeal attacks
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: C1 esterase inhibitors (human) (Berinert®) is re-approved with documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
INITIAL CRITERIA: C1 esterase inhibitor recombinant (Ruconest®) is approved when ALL of the following are met: 1. Diagnosis of hereditary angioedema (HAE); and 2. One of the following: a. Diagnosis has been confirmed by C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following:
i. C1-INH antigenic level below the lower limit of normal; or ii. C1-INH functional level below the lower limit of normal; or b. Diagnosis has been confirmed by both of the following: i. Member has normal C1-INH level (HAE-n1-C1INH previously referred to as HAE Type 3); and ii. One of the following: - Confirmed presence of a FXII, plasminogen gene mutation, angiopoietin-1 mutation, or kininogen mutation; or
- Member has recurrent angioedema attacks that are refractory to high-dose antihistamines (e.g., cetirizine) with a confirmed family history of recurrent angioedema; and
- Prescribed by or in consultation with an immunologist, allergist, or pulmonologist; and
- Member is 13 years of age or older; and
- For the treatment of acute HAE attacks
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA: C1 esterase inhibitor recombinant (Ruconest®) is re-approved with documentation of positive clinical response to therapy
Reauthorization duration: 2 years INITIAL CRITERIA: Icatibant (Firazyr® /Sajazir™) is approved when ALL of the following are met: 1. Member is 18 years of age or older; and 2. Diagnosis of hereditary angioedema; and 3. One of the following: a. Diagnosis has been confirmed by C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following:
i. C1-INH antigenic level below the lower limit of normal; or ii. C1-INH functional level below the lower limit of normal; or b. Diagnosis has been confirmed by both of the following: i. Member has normal C1-INH level (HAE-n1-C1INH previously referred to as HAE Type 3); and ii. One of the following: - Confirmed presence of a FXII, plasminogen gene mutation, angiopoietin-1 mutation, or kininogen mutation; or
- Member has recurrent angioedema attacks that are refractory to high-dose antihistamines (e.g., cetirizine) with a confirmed family history of recurrent angioedema; and
- For the treatment of acute HAE attacks; and
- Prescribed by or in consultation with an immunologist, allergist, or pulmonologist
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA Icatibant (Firazyr®/Sajazir™) is re-approved with documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
| | | Firazyr® (icatibant) [package insert]. Lexinton MA. Shire Orphan Therapeutics. Oct, 2021 Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ed6657ca-ab68-477a-9968-e12dc928b540&type=display. Accessed August 4, 2024
Zuraw BL, Bernstein JA, Lang DM, et al. A focused parameter update: hereditary angioedema, acquired C1 inhibitor deficiency, and angiotensin-converting enzyme inhibitor-associated angioedema. J Allergy Clin Immunol. 2013; Volume 131, issue 6, pages 1491-1493.e25. Accessed August 4, 2024.
Haegarda® (C1 esterase inhibitor subcutaneous [human]). [package insert]. Kanakee, IL: CSL Behring. January 2022. Available at: http://labeling.cslbehring.com/PI/US/HAEGARDA/EN/HAEGARDA-Prescribing-Information.pdf. Accessed August 4, 2024.
Cinryze® (C1 esterase inhibitor [human]). [package insert]. Lexington, MA: Shire ViroPharma Inc. January 2021. Available at: http://pi.shirecontent.com/PI/PDFs/Cinryze_USA_ENG.pdf. Accessed August 4, 2024.
Berinert® (C1 esterase inhibitor [human]). [package insert]. Kanakee, IL: CSL Behring. September 2021. Available at: http://labeling.cslbehring.com/PI/US/Berinert/EN/Berinert-Prescribing-Information.pdf. Accessed August 4, 2024
Orladeyo™ (berotralstat). [prescribing information]. Durham, NC: BioCryst Pharmaceuticals, Inc. March 2022. Available at: https://orladeyohcp.com/wp-content/uploads/ORLADEYO_PI_V1_2020.pdf. Accessed August 4, 2024.
Ruconest® (C1 esterase inhibitor [recombinant]). [package insert]. Raleigh, NC: Santarus, Inc. April 2020. Available at: https://www.ruconest.com/PDF/ruconest-pi.pdf. Accessed August 4, 2024
Sajazir™ (icatibant) [package insert]. Cambridge, United Kingdom. Cycle Pharmaceuticals Ltd. June 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1756aca0-21a1-4898-8d6c-9666738db45c. Accessed August 4, 2024
Takhzyro®. [package insert]. Lexington, MA: Dyax Corp., wholly-owned subsidiary of Shire US Inc. February 2023. Available at: https://www.shirecontent.com/PI/PDFs/TAKHZYRO_USA_ENG.pdf. Accessed August 4, 2024.
Zuraw B MD, Farkas H MD. Hereditary angioedema (due to C1 inhibitor deficiency): Pathogenesis and diagnosi. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. Accessed on August 4, 2024
| 21 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:15 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Firazyr®/Sajazir™ | icatibant | | Haegarda® | C1 esterase inhibitor subcutaneous [human] | Cinryze®
| C1 esterase inhibitor [human] | | Berinert® | C1 esterase inhibitor [human] | | Orladeyo™ | berotralstat | | Ruconest® | C1 esterase inhibitor [recombinant] | | Takhzyro® | lanadelumab-flyo |
| NA | NA | | 455 | | | 10/1/2024 | Rx.01.228 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Elevated triglyceride levels are associated with and appear to be implicated in the pathogenesis of atherosclerosis and cardiovascular disease (CVD). Atherosclerosis is the most common underlying pathology in patients with CVD. Fasting plasma triglyceride concentrations may be categorized according to the National Cholesterol Education Program (NCEP) as normal (<150 mg/dL), borderline (150–199 mg/dL), high triglyceride (HTG; 200–499 mg/dL), and severe HTG (HTG; ≥500 mg/dL). Patients with triglycerides above 500 mg/dL are also at risk of pancreatitis. Elevated plasma triglyceride concentrations contribute to increased risk of cardiovascular disease, both directly and because such elevations are associated with risk factors such as obesity, metabolic syndrome, and type 2 diabetes mellitus. Diet and lifestyle changes along with treatment or elimination of secondary causes are recommended before direct pharmacotherapy. If these changes are not possible or not effective, initiating triglyceride-lowering pharmacotherapy may be required. Vascepa® (icosapent ethyl) is indicated: - As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- Established cardiovascular disease or
- Diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The mechanisms of action contributing to reduction of cardiovascular events with Vascepa® (icosapent ethyl) are not completely understood but are likely multi-factorial. Increased omega-3 fatty acid eicosapentaenoic acid (EPA) lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment. EPA inhibits platelet aggregation under some ex vivo conditions. However, the direct clinical meaning of individual findings is not clear.
| The intent of this policy is to communicate the medical necessity criteria for icosapent ethyl (Vascepa®) as provided under the member's prescription drug benefit.
| Severe Hypertriglyceridemia INITIAL CRITERIA: Icosapent ethyl (Vascepa®) is approved when ALL of the following are met: - Diagnosis of severe hypertriglyceridemia defined as pre-treatment triglyceride level greater than or equal to 500 mg/dl; and
- Member is 18 years of age or older; and
- Medication will be used adjunct to an appropriate lipid-lowering diet; and
- Member has an inadequate response or inability to tolerate omega-3-acid ethyl esters (generic Lovaza®); and
- For Brand Vascepa® only, inadequate response or inability to tolerate generic Icosapent ethyl capsules
Initial authorization duration: 6 Months REAUTHORIZATION CRITERIA: Icosapent ethyl (Vascepa®) is approved when ALL of the following are met: - Documentation of positive clinical response to therapy; and
- Member continues to use the medication adjunct to an appropriate lipid-lowering diet
Reauthorization duration: 2 years ________________________________________________________________________________________ Hypertriglyceridemia—Reduction of risk of cardiovascular events INITIAL CRITERIA Icosapent ethyl (Vascepa®) is approved when ALL of the following are met: - Diagnosis of hypertriglyceridemia; and
- Member is 18 years of age or older; and
- Member has pre-treatment triglyceride level between 150 mg/dL to 499 mg/dL; and
- ONE of the following:
- Member has established cardiovascular disease; or
- Both of the following:
- Diagnosis of diabetes mellitus; and
- Member has 2 or more additional risk factors for cardiovascular disease (e.g., cigarette smoking, hypertension, creatinine clearance less than 60 ml/min, etc.); and
- One of the following:
- Member has been receiving 12 consecutive weeks of statin therapy at maximally tolerated dose and will continue to receive statin therapy at maximally tolerated dose; or
- Inability to tolerate statin therapy; and
- For Brand Vascepa® only, inadequate response or inability to tolerate generic Icosapent ethyl capsules
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA Icosapent ethyl (Vascepa®) is re-approved when BOTH of the following are met: - Documentation of positive clinical response to therapy; and
- One of the following:
- Member continues to receive statin therapy at maximally tolerated dose; or
- Inability to tolerate statin therapy
Reauthorization duration: 2 years
| | | Skulas-Ray AC, Wilson PWF, Harris WS et al on behalf of the American Heart Association. Omega-3 fatty acids for the management of hypertriglyceridemia. Circulation. 2019;140. Accessed August 4, 2024
Vascepa® (icosapent ethyl) [prescribing information]. Bridgewater, NJ: Amarin Pharma, Inc.; September 2021. Available from: https://amarincorp.com/docs/Vascepa-PI.pdf. Accessed August 4, 2024 Yuan, G, Al-Shali, KZ, Hegele, RA. Hypertriglyceridemia: its etiology, effects and treatment. CMAJ. 2007;176:1113–1120. doi: 10.1503/cmaj.060963. Accessed August 4, 2024
| 6 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:15 AM | srv_ppsgw_P | | | Brand name | Generic name | | Vascepa® | Icosapent ethyl |
| NA | NA | | 456 | | | 10/1/2024 | Rx.01.184 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | An interim clinical policy is the written description of the plan’s utilization management position concerning the use or application of a new or recently introduced product that is covered under the pharmacy benefit. These policies are implemented prior to review by the Pharmacy and Therapeutics Committee. Criteria are based on an initial clinical review performed by Clinical Pharmacy Services. The intent of the interim policy is to provide a means to manage newly approved products while allowing sufficient time for a thorough clinical review and evaluation by the Pharmacy and Therapeutics Committee. The product to which an interim clinical policy applies is considered medically necessary when requested for an indication approved by the Food and Drug Administration and, when available, there is inadequate response or inability to tolerate one generic alternative and one preferred brand with the same indication. The policy is effective as of the date of market entry. A clinical policy, if issued, will be available when approved by the Pharmacy and Therapeutics Committee within 180 days of the drug market entry, designated by the Medispan release date. If a clinical policy is not approved within 180 days, the interim clinical policy will be retired. Interim clinical policy will remain in effect until the clinical policy effective date.
| The intent of this policy is to communicate the medical necessity criteria for new or recently introduced products as provided under the member’s prescription drug benefit.
| A new or recently introduced product is approved when both of the following are met: - Diagnosis of an FDA approved, or compendia supported, indication; and
- Inadequate response or inability to tolerate BOTH of the following (when available):
- One generic alternative with the same indication; and
- One preferred brand with the same indication
Authorization duration: 1 year A new authorized generic/authorized brand alternative is approved when all of the following are met: - Diagnosis of an FDA approved, or compendia supported, indication; and
- Submission of documentation (e.g., chart note) or claim history showing at least 3 months of use of the brand product within the previous 365 days; and
- Submission of documentation (e.g., chart note) confirming BOTH of the following:
- The brand product has not been effective; and
- Justification for why the target drug is expected to provide benefit when the brand product has not been shown to be effective
Authorized duration: 1 year
| | | | 9 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:15 AM | srv_ppsgw_P | | Applicable drugs will vary as new products are released to market.
| NA | NA | | 457 | | | 10/1/2024 | Rx.01.265 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | The intent of this policy is to communicate the medical necessity criteria for Mavacamten (Camzyos™) as provided under the member's prescription drug benefit.
| Hypertrophic cardiomyopathy (HCM) is a common inherited cardiovascular disease characterized by hypertrophy of a nondilated left ventricle in the absence of any other cardiac or systemic disease (such as hypertension) that could account for observed hypertrophy, microvascular dysfunction and myocardial fibrosis. Histopathological features include myofiber disarray and myocardial fibrosis resulting from microvascular ischemia and cell death. HCM is caused largely by mutations in genes encoding thick and thin contractile myofilament proteins of the cardiac sarcomere. Phenotypically, HCM can be obstructive (70% of patients), with presence of left ventricular outflow tract obstruction, or nonobstructive (30% of patients). Complications include syncope, heart failure, and sudden death.
Mavacamten is an allosteric and reversible inhibitor selective for cardiac myosin. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. Mavacamten shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with mavacamten reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.
Mavacamten is indicated for treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
| INITIAL CRITERIA: Mavacamten (Camzyos™) is approved when ALL of the following are met: - Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM); and
- Members is 18 years of age or older; and
- Member's baseline left ventricular ejection fraction (LVEF) is greater than or equal to 55%; and
- Member has Valsalva left ventricular outflow tract (LVOT) peak gradient greater than or equal to 50 mmHg at rest or with provocation; and
- Inadequate response or inability to tolerate BOTH of the following at a maximally tolerated dose:
- Non-vasodilating One beta blocker (e.g., bisoprolol, propranolol); and
- Calcium channel blocker (e.g., verapamil, diltiazem); and
- Prescribed by or in consultation with a cardiologist
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: Mavacamten (Camzyos™) is re-approved when ALL of the following are met: - Documentation of positive clinical response to therapy (e.g., improved symptom relief); and
- Member's left ventricular ejection fraction (LVEF) is greater than or equal to 50%; and
- Prescribed by or in consultation with a cardiologist.
Reauthorization duration: 12 months
| Risk of Heart Failure - CAMZYOS can cause heart failure due to systolic dysfunction.
- Echocardiogram assessments of left ventricular ejection fraction (LVEF) required before and during CAMZYOS use.
- Initiation in patients with LVEF <55% not recommended. Interrupt if LVEF <50% or if worsening clinical status.
- Certain CYP450 inhibitors and inducers are contraindicated in patients taking CAMZYOS because of an increased risk of heart failure.
CAMZYOS is available only through a restricted program called the CAMZYOS REMS Program.
| | DynaMed. Hypertrophic Cardiomyopathy. EBSCO Information Services. https://www.dynamed.com/condition/hypertrophic-cardiomyopathy. Accessed August 4, 2024 Camzyos™ (mavacamten) [prescribing information]. Brisbane, CA: MyoKardia, Inc.; June 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214998s000lbl.pdf. Accessed August 4, 2024
| 4 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:15 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | CamzyosTM | Mavacamten |
| N/A | N/A | | 458 | | | 10/1/2024 | Rx.04.6 | Claim Payment Policy | Oyenusi, Oluwadamilola | Q2-2024 | Injectable drugs indicated for administration by a healthcare professional are covered under the medical benefit. There are times when an exception is requested to cover such drugs under the member's prescription drug benefit where they are otherwise excluded.
| The intent of this policy is to describe circumstances when injectable medications typically covered under the medical benefit may be covered under the member’s prescription drug benefit.
| Coverage is subject to the terms, conditions, and limitations of the member's contract. The following medications are covered under the medical benefit: - Cyanocobalamin (vitamin B12) injection
- Heparin injection
- Hydrocortisone injection
- Methotrexate injection (vial)
- Non-insulin syringes/needles
A benefit exception will be made to cover cyanocobalamin injection, heparin injection, hydrocortisone injection, methotrexate vials under the prescription drug benefit when ALL of the following are met: - The requested drug is being used for a Food and Drug Administration approved indication or compendium supported indication as outlined in Off-label Use policy; and
- The prescriber assumes responsibility for teaching the member proper preparation, administration and disposal; and
- The prescriber provides a statement indicating the reason prescription drug benefit products are not an option, and
- ONE of the following:
- Provider does not stock the requested medication; or
- Access at the provider's office is not feasible due to frequency of administration
A benefit exception will be made to cover non-insulin syringes/needles under the prescription drug benefit when required to administer an injectable medication and not supplied with the product. Coverage is subject to the terms of the member's prescription drug benefit, including but not limited to cost-share. Authorization duration: 2 years
| | | | 12 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:15 AM | srv_ppsgw_P | | | N/A | N/A | | 459 | | | 10/1/2024 | Rx.01.266 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Hemolytic anemia is a disease that results in the premature death (hemolysis) of red blood cells (RBC) at a faster rate than the body can produce. Hemolytic anemia can be categorized as intrinsic and extrinsic. Intrinsic hemolytic anemia is genetically inherited and results in abnormalities in the cell membrane and overall blood cell production. Extrinsic hemolytic anemia is acquired as a secondary effect resulting from certain immunologic diseases, infections and medications. The glycolytic pathway is a metabolic pathway that breaks down glucose into pyruvate via the Pyruvate kinase (PK) enzyme, which leads to the production of ATP and NADH. A deficiency in the pyruvate kinase enzyme in homozygous patients causes a defect in the glycolytic pathway that is known to cause hemolytic anemia. The exact mechanism of hemolysis is unknown.
Mitapivat is a Pyruvate Kinase activator that targets defective PK enzymes in RBC’s.
Mitapivat (Pyrukynd®) is indicated for the treatment hemolytic anemia in adults with a PK enzyme deficiency.
| The intent of this policy is to communicate the medical necessity criteria for Mitapivat (Pyrukynd®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Mitapivat (Pyrukynd®) is approved when ALL of the following are met: - Diagnosis of hemolytic anemia confirmed by the presence of chronic hemolysis (e.g., increased indirect bilirubin, elevated lactated dehydrogenase [LDH], decreased haptoglobin, increased reticulocyte count); and
- Diagnosis of pyruvate kinase deficiency confirmed by molecular testing of ALL of the following mutations on the PLKR gene:
- Presence of at least 2 variant alleles in the pyruvate kinase liver and red blood cell (PKLR) gene, of which at least 1 was a missense variant; and
- Member is not homozygous for the c.1436G>A (p.R479H) variant; and
- Member does not have 2 non-missense variants (without the presence of another missense variant) in the PKLR gene; and
- Hemoglobin is less than or equal to 10g/dL; and
- Member has symptomatic anemia or is transfusion dependent; and
- Other causes of hemolytic anemias (e.g., infections, toxins, drugs) were ruled out; and
- Member is 18 years of age and older; and
- Prescribed by or in consultation with a hematologist
Initial authorization duration: 6 months REAUTHORIZATION CRITERIA: Mitapivat (Pyrukynd®) re-approved when ALL of the following are met: - Documentation of positive clinical response to therapy (e.g., hemoglobin greater than or equal to 1.5g/dL from baseline sustained on 2 or more follow ups (weeks 16, 20 and 24) during the fixed dose period without transfusions; reduction in transfusions of greater than or equal to 33% in the number of red blood cell units transfused during the fixed dose period compared with the member's historical transfusion burden; improvement in markers of hemolysis from baseline (e.g., bilirubin, lactated dehydrogenase [LDH], haptoglobin, reticulocyte count)); and
- Prescribed by or in consultation with a hematologist
Reauthorization duration: 12 months
| | | Pyrukynd® (mitapivat) [prescribing information]. Agios Pharmaceuticals, Inc.; February 2022. https://www.pyrukynd.com/hcp/. Accessed August 4, 2024
Braunstein EM. Glycolytic Pathway Defects. Merck & Co., Inc., Rahway, NJ.; June 2022. https://www.merckmanuals.com/professional/hematology-and-oncology/anemias-caused-by-hemolysis/glycolytic-pathway-defects. Accessed August 4, 2024.
| 3 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:16 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Pyrukynd | Mitapivat |
| N/A | N/A | | 460 | | | 10/1/2024 | Rx.04.2 | Claim Payment Policy | Oyenusi, Oluwadamilola | Q2-2024 | Presently, the FDA requires prescription drugs to demonstrate safety and efficacy prior to marketing, however, this was not always mandatory. In 1906, the Pure Food and Drug Act prohibited adulterated, misbranded, poisonous or deleterious drugs from being manufactured, sold or transported. The Pure Food and Drug Act was repealed and replaced with the Federal Food, Drug, and Cosmetic Act of 1938, which required evidence of safety for new drugs. The law was amended further in 1962 to strengthen the requirements for safety and add an additional requirement for a manufacturer to demonstrate efficacy of the drug. The Orange Book identifies FDA approved drugs that have undergone the required safety and efficacy requirements of the Federal Food, Drug, and Cosmetic Act. If a medication is not included in the orange book, it has not demonstrated safety and efficacy in accordance with the Federal Food, Drug, and Cosmetic Act requirements. Drugs that entered the market based solely on safety and drugs that were on the market prior to 1938 are not included in the Orange Book. Some drugs, mostly older products, are available on the market despite lacking FDA approval for a variety of historical reasons. Examples include, but are not limited to, a manufacturer combining two approved products into a combination product without obtaining approval and a manufacturer marketing a currently approved product without obtaining FDA approval. Prescription Drugs are defined by the plan as: A Legend Drug or Controlled Substance, which:
- Has been approved by the Food and Drug Administration(FDA) for a specific use; and
- Can, under federal or state law, be dispensed only pursuant to a Prescription Order
A non-FDA approved drug will be considered for formulary inclusion if all the following criteria are met: - The drug entered the market prior to 1938; and
- The drug is not commercially available in an FDA approved form of the same route of administration; and
- The drug meets the criteria outlined in the Experimental/Investigational Use Policy
The prescription drug benefit covers certain prescription drugs approved by the FDA pursuant to a prescription order. Details of covered drugs may be found in the member’s benefit booklet. | The intent of this policy is to communicate the prescription drug benefit coverage based on medical necessity of drugs that are not approved by the Food and Drug Administration (FDA).
| Coverage is subject to the terms, conditions, and limitations of the member's contract. Prescription drugs that are commercially available but not approved by the FDA are not considered a covered benefit. Some prescription drugs that are not FDA approved, and not otherwise excluded, will be covered under the pharmacy benefit for certain plans as required by the Patient Protection and Affordable Care Act (PPACA) or as defined in the member's benefit booklet. These items include but may not be limited to the following products as listed: - Prenatal vitamins, oral
- Preventative vitamins and minerals as required by the PPACA
- Cholecalciferol (vitamin D3) 50,000 units*
- Sulfuric acid/phenolsulfonic acid solution*
Some prescription drugs that came to market prior to 1938, prior to the current FDA approval process, and not otherwise excluded, will be covered under the prescription drug benefit if they are deemed medically accepted as defined in the Off-Label Use policy. These items include but may not be limited to the following products as listed: - Aluminum chloride topical
- Hydrocortisone suppositories
- Hyoscyamine
- Phenobarbital
- Opium tincture
- Morphine suppositories
- Sodium chloride for inhalation
- Homatropine ophthalmic
- Thyroid products (e.g., Armour Thyroid, Nature-Thyroid, NP Thyroid, WP Thyroid)
- Phenazopyridine HCL (Pyridium) 100mg and 200mg tablets
- Nitro-time CPCR
- Salsalate tablet
*Exceptions will be made for these products to meet essential health benefit requirements
| | | | 13 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:16 AM | srv_ppsgw_P | Rx.04.5 Prescription Vitamins, Dietary Supplements, and Medical Foods
Rx.01.33 Off-Label Use
| | N/A | N/A | | 462 | | | 10/1/2024 | Rx.01.197 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Opioid analgesics are classified as full agonists, mixed agonist-antagonists, or partial agonists by their activity at opioid receptors. There are three major classes of opioid receptors in the central nervous system (CNS): mu, kappa, and delta. Mu-receptor activation causes analgesia, respiratory depression, miosis, reduced GI motility, and euphoria. Kappa-receptor activation also causes analgesia, but may also produce effects such as dysphoria and hallucinations, which limit use. Delta-receptor activation produces some analgesia but may also cause seizures at high doses and has some antidepressant effects. Morphine-like opioid agonists have activity at the mu, kappa, and delta receptors, but have the highest affinity for the mu receptors1. Opioid agonists include natural opium alkaloids (e.g., codeine, morphine), semisynthetic analogs (e.g., hydrocodone, hydromorphone, oxycodone, oxymorphone), and synthetic compounds (e.g., fentanyl, levorphanol, methadone, sufentanil, tapentadol, tramadol). There is no defined maximum dose for most opioids. The ceiling to analgesic effectiveness is imposed only by adverse reactions. Adverse effects of opioids include constipation, nausea and vomiting, dizziness, sedation, respiratory depression2. Long-term use of high dose narcotics may also have significant adverse effects including but not limited to endocrinological effects, such as, hypogonadism, impotence in males, menstrual irregularities, and galactorrhea in women; and opioid induced hyperanalgesia caused by damage to the nociceptors thus increasing pain sensitivity3.
Opioid analgesics are commonly prescribed in pain management. Pain is classified into non-cancer and cancer related pain. Non-cancer related pain may be acute or chronic while cancer-related pain may be a mixture of both2. When using opioid agents to manage pain, the choice should be made based on patient acceptance, pain intensity, analgesic effectiveness, pharmacodynamic, pharmacokinetic and side effect profiles. Like the treatment of many disease states, pain treatment should be initiated with the most effective agent with minimal side effects. Prior to starting patient on opioid pain management, pain severity and intensity should be thoroughly assessed using patient medical history, physical examination and different pain assessment tools4. In the management of mild non-cancer pain, the American Pain Society recommends the use of non-opioid analgesics such as acetaminophen and NSAIDs as first line agents. If pain relief is not adequate, opioid analgesics could be considered as the next line of treatment. Combination treatments of opioid with acetaminophen or NSAIDs are recommended when treating moderate to severe non-cancer pain. Common opioid analgesics like oxycodone and hydrocodone are often co-formulated with acetaminophen or NSAIDs and have a maximum dose to limit the amount of acetaminophen and NSAIDs exposure. It is recommended not to exceed 4000 mg of acetaminophen per day, 3200 mg of ibuprofen or 4000 mg (3900mg for controlled-, extended-, and delayed-release products) of aspirin daily. Pain that is associated with cancer or a malignant condition is known as cancer related pain. Cancer related pain may be acute and/or chronic. Pain related to cancer is usually the result of damage to parts of the body from cancer metastasis or therapies such as chemotherapy, radiation and surgical procedures. Opioid analgesics play an important role in pain management for oncology patients. The World Health Organization (WHO) developed a pain relief regimen known as the WHO's Pain Relief Ladder which provides guidelines for pain management in cancer patients5. Like non-cancer related pain, opioid analgesics are reserved for moderate to severe cancer pain. Patients with mild pain should try non-opioid analgesics such as acetaminophen, ibuprofen, or naproxen first. Opioid agents or opioid combination are reserved for moderate to severe cancer pain or when inadequate pain relief is not achieved with non-opioid analgesics. The potency of opioids is not consistent across all medications. Morphine milligram equivalents (MME) is a conversion factor used to standardize the dose of an opioid into the equivalent dose of morphine to easily compare doses of different opioid agents and assess the risk of the doses. Conversion factors are included in the table below. Several utilization tools are in place to prevent abuse and overuse of opioids. These include MME limits, days' supply limits, and quantity limits. - MME limits: MME Limits are in place to limit the total dosage of opioids a patient can receive in a day. Regimens, whether single drug or multiple drugs, that exceed 90 MME are subject to MME limit. Higher doses of opioids, along with other factors, are associated with increased risk of opioid overdose. The threshold of 90 MME is based on the recommendations from the Centers for Disease Control and Prevention: “When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day."
- Days' Supply Limits: Day supply limits are in place to limit the total days a patient can receive opioids. “The probability of long-term opioid use increases most sharply in the first days of therapy, particularly after 5 days or 1 month of opioids have been prescribed," according to the Centers for Disease Control and Prevention (CDC). Long-term opioid use often begins with treatment of acute pain. To address these statistics, all opioids individual opioids with a dose less than or equal to 90 morphine milligram equivalents (MME) are subject to 5 days' supply limit. Continuation beyond five days requires review.
- Quantity Limits: Quantity limits are in place to optimize doses and achieve the prescribed dose using the least number of tablets, capsules, patches, films, liquids, suppositories, etc. that a patient can receive in a day. Opioids are subject to limits on the quantity per day. While opioid doses are variable and may have no true maximum, quantity limits are in place to address safety concerns, including abuse, addiction, and diversion. The limits in this policy restrict quantities to either the daily MME of 90 mg of a single agent or the FDA limit of additional product components such as 4 grams of acetaminophen, 3.2 grams of ibuprofen or 4 grams of aspirin
Morphine Milligram Equivalent (MME) Conversion Factors for Commonly Prescribed Opioid Analgesics | Opioid Oral Morphine Milligram Equivalent (MME) Conversion Factors12 | | | Type of Opioid (strength units) | MME Conversion Factor | | Buprenorphine film/tablet (mg) | 30 | | Buprenorphine patch (mcg/hr) | 12.6 | | Buprenorphine film* (mcg) | 0.03 | | Butorphanol (mg) | 7 | | Codeine (mg) | 0.15 | | Dihydrocodeine (mg) | 0.25 | | Fentanyl buccal or SL tablets, or lozenge/troche (mcg) | 0.13 | | Fentanyl film or oral spray (mcg) | 0.18 | | Fentanyl nasal spray (mcg) | 0.16 | | Fentanyl patch** (mcg) | 7.2 | | Hydrocodone (mg) | 1 | | Hydromorphone (mg) | 5 | | Levorphanol tartrate (mg) | 11 | | Meperidine hydrochloride (mg) | 0.1 | | Methadone (mg) | 4.7 | | Morphine (mg) | 1 | | Opium (mg) | 1 | | Oxycodone (mg) | 1.5 | | Oxymorphone (mg) | 3 | | Pentazocine (mg) | 0.37 | | Tapentadol (mg) | 0.4 | | Tramadol (mg) | 0.2
|
These conversion factors will be used to determine the MME/day of all opioids being prescribed. Calculate the total daily dose of the opioid in the left column and multiply by the conversion factor to determine to MME/ day. If multiple agents are being used, add the MME of the individual agents to get the total MME of the regimen. These values do not constitute clinical guidance or recommendations for converting patients from one form of opioid analgesic to another. Extra caution applies to methadone (conversion factor depends on dose) and fentanyl (patches are dosed in mcg/hour rather than mg/day). Please consult the manufacturer's full prescribing information for such guidance. 12 These conversion factors are based on CMS “Opioid Oral Morphine Milligram Equivalent (MME) Conversion Factors" found here: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-Aug-2017.pdf *The MME conversion factor for buprenorphine patches is based on the assumption that one milligram of parenteral buprenorphine is equivalent to 75 milligrams of oral morphine and that one patch delivers the dispensed micrograms per hour over a 24 hour day. Example: 5 ug/hr buprenorphine patch X 24 hrs = 120 ug/day buprenorphine = 0.12 mg/day = 9 mg/day oral MME. In other words, the conversion factor not accounting for days of use would be 9/5 or 1.8. However, since the buprenorphine patch remains in place for 7 days, we have multiplied the conversion factor by 7 (1.8 X 7 = 12.6). In this example, MME/day for four 5 µg/hr buprenorphine patches dispensed for use over 28 days would work out as follows: Example: 5 ug/hr buprenorphine patch X (4 patches/28 days) X 12.6 = 9 MME/day. Please note that because this allowance has been made based on the typical dosage of one buprenorphine patch per 7 days, you should first change all Days Supply in your prescription data to follow this standard, i.e., Days Supply for buprenorphine patches= # of patches x 7 **The MME conversion factor for fentanyl patches is based on the assumption that one milligram of parenteral fentanyl is equivalent to 100 milligrams of oral morphine and that one patch delivers the dispensed micrograms per hour over a 24 hour day. Example: 25 ug/hr fentanyl patch X 24 hrs = 600 ug/day fentanyl = 60 mg/day oral morphine milligram equivalent. In other words, the conversion factor not accounting for days of use would be 60/25 or 2.4. However, since the fentanyl patch remains in place for 3 days, we have multiplied the conversion factor by 3 (2.4 X 3 = 7.2). In this example, MME/day for ten 25 µg/hr fentanyl patches dispensed for use over 30 days would work out as follows: Example: 25 ug/hr fentanyl patch X (10 patches/30 days) X 7.2 = 60 MME/day. Please note that because this allowance has been made based on the typical dosage of one fentanyl patch per 3 days, you should first change all Days Supply in your prescription data to follow this standard, i.e., Days Supply for fentanyl patches= # of patches X 3. Butalbital containing products in tension-type headache Butalbital is a barbiturate that is commonly prescribed in combination with acetaminophen and caffeine to treat different types of headaches such as tension-type and migraines. It works by decreasing motor activity and depress the sensory cortex causing CNS depression ranging from sedation to general anesthesia6. The analgesia effect of barbiturate is unknown. However, there are limited studies that show the efficacy of butalbital in the treatment of tension type headache and migraine7. In addition, overuse of barbiturate products could lead to dependency, withdrawal, and drug-induced headache. Therefore, when selecting a treatment for tension-type headache as well as other types of headaches, butalbital containing products should only be used if first line analgesics like acetaminophen or NSAIDs provide insufficient relief. In acute management, butalbital products should not be used more than 3 days7. Opioid Containing Cough and cold products Opioid containing cough and cold products are thought to suppress cough via action on the central cough center. While the products are widely used, data are limited regarding efficacy. Like opioids used to treat pain, cough and cold products containing an opioid are subject to days' supply limits, quantity limits, and morphine milligram equivalent (MME) limits.
Days' Supply and Quantity limits Quantity limits are designed to allow a sufficient supply of medication based upon FDA-approved or medically accepted maximum daily doses and length of therapy of a particular drug. Quantity limits may be expressed as quantity over time or maximum daily dose. Additionally, there are some medications to which a limit on the days' supply is applied. - Quantity over time: This quantity limit is based on dosing guidelines over a rolling time period, usually 30 days.
- Maximum daily dose (maximum quantity per day): This quantity limit is based on maximum number of units of the drug allowed per day.
- Days' supply limit: This limits the numbers of days of therapy within a defined period of time. Maximum daily dose applies to days' supply limits.
Summary Of Utilization Managment | Summary Table of Criteria on Opioid Medications | | | | | Criteria | Short Acting Opioids | Long Acting Opioids (including opioid patches) | Transmucosal Immediate Release Fentanyl (TIRF) | | MME Limit | Yes | Yes | Yes | | Day Supply Limit | Yes* | No | No | | Quantity Limit | Yes | Yes | Yes | | Opioid Prior Authorization | No* | Yes | Yes |
| *Note: short-acting opioids are available without prior authorization for two 5-day supplies within 60 days or less. Greater than a total of a 10 day supply within 60 days requires prior authroization.
|
| The intent of this policy is to communicate the medical necessity criteria including prior authorization, quantity limits, and days’ supply for opioid analgesics, buprenorphine containing medication assistant treatments, and butalbital containing headache medications as provided under the member's prescription drug benefit.
| PRIOR AUTHORIZATION I. Transmucosal Immediate Release Fentanyl (TIRF) Product fentanyl citrate is considered medically necessary when:
A. INITIAL CRITERIA [Authorization duration: 1 year]: Transmucosal Immediate Release Fentanyl (TIRF) Products are considered medically necessary when there is documentation of ALL of the following: - Use for breakthrough pain associated with active cancer treatment or cancer not in remission in members who are receiving long-acting opioid therapy; and
- Member is 18 years of age or older (16 years of age and older for fentanyl citrate); and
- Member is tolerant to current opioid therapy (i.e., adherence to one of the following regimens for one week or longer: 25mcg of transdermal fentanyl hourly, 30mg of oxycodone daily, 60mg of oral morphine daily, 8mg of oral hydromorphone daily, 25mg of oral oxymorphone daily; or an equianalgesic dose of another opioid)
B. REAUTHORIZATION CRITERIA [Authorization duration: 1 year]: Transmucosal Immediate Release Fentanyl (TIRF) product is re-approved when there is documentation of continued use for breakthrough pain associated with active cancer treatment or cancer not in remission in members who are currently receiving long-acting opioid therapy
II. Opioid regimens containing greater than 90 morphine milligram equivalents per day, long acting opioids, and short acting opioids for continuation beyond 30 days [Authorization duration: 1 year] - are considered medically necessary as follows:
A. INITIAL CRITERIA: The requested product or regimen is considered medically necessary when there is ONE of the following:
1. Pain associated with active cancer treatment, cancer not in remission, or sickle cell anemia (regardless of age); OR
2. Severe, persistent chronic pain with documentation of diagnosis associated with pain and ALL of the following: - Documentation of a current patient-prescriber opioid treatment agreement (signed within one year of request); and
- ONE of the following
- Regimen prescribed by or in consultation with a pain management specialist within last 6 months. Must provide name of physician and date of last visit. Physician must be Board Certified by one of the following:
- American Board of Anesthesiology- Pain Management; or
- American Board of Psychiatry & Neurology- Pain Management; or
- American Board of Physical Medicine & Rehabilitation; or
- American Osteopathic Association- Pain Management
or
- The member has been evaluated for at least TWO of the following therapies:
- Physical therapy; or
- Psychotherapy; or
- Adjuvant medications specific to causative condition including but not limited to any of the following: antidepressants, anticonvulsants, muscle relaxants, anti-inflammatory agents.
B. REAUTHORIZATION CRITERIA [Authorization duration: 1 year]: Re-authorization of the requested opioid product or regimen containing greater than 90 morphine milligram equivalents per day, long acting opioids, and short acting opioids for continuation beyond 30 days is considered medically necessary when there is documentation of ONE of the following: - Pain associated with active cancer treatment, cancer not in remission, or sickle cell anemia (regardless of age) AND documentation that a urine drug screen (UDS) will performed by prescriber within 1 year of request.
OR 2. Severe, persistent chronic pain with documentation of diagnosis associated with pain and ALL of the following: - Documentation of a current patient-prescriber opioid treatment agreement (signed within one year of request); and
- documentation that a urine drug screen (UDS) will be performed by prescriber within 1 year of request.
III. Appropriate Utilization with Medication Assistant Treatments (MAT) for opioid use disorder - [Authorization duration: 2 months] - Opioid analgesics will require prior authorization for medical necessity when filled within two months of a paid claim for either buprenorphine/naloxone (Bunavail®/Suboxone®/Zubsolv®) or buprenorphine sublingual tablet. Opioid analgesic products are approved in patients that have received buprenorphine/naloxone or buprenorphine in the previous two months when there is documentation of a treatment plan showing discontinuation of buprenorphine containing MAT.
DAYS' SUPPLY AND QUANTITY LIMITS
I. Day supply limit Criteria
A. Short-acting opioids for short term use (greater than two 5-day fills within 60 days for 18 and older, and greater than two 3-day fills within 60 days for age less than 18) [Authorization duration: 1 month for a 30 days' supply] - an exception is approved when ALL of the following are met:
INITIAL CRITERIA - Diagnosis of acute pain; and
- Prescriber reviewed member's history in state Prescription Drug Monitoring Program website; and
- Prescriber counseled member (or member's representative) on risk of addiction; and
- Substance abuse screening done by prescriber
REAUTHORIZATION CRITERIA see Opioid regimens containing greater than 90 morphine milligram equivalents per day, long acting opioids, and short acting low dose opioids for continuation beyond additional 30 days Prior Authorization criteria under section under section II.A above B. Opioid containing cough and cold products are limited to two five (5) day fills within 60 days for 18 and older and two 3-day fills within 60 days for age less than 18 - an exception is approved when
INITIAL CRITERIA: there is documentation of inadequate response or inability to tolerate non-opioid therapies for the indication [Authorization duration 1 month]
EAUTHORIZATION CRITERIA: Documentation the underlying etiology of cough has been identified and treated, if applicable (e.g,, allergic rhinitis, asthma, GERD) [Authorization duration 6 months]
C. Butalbital containing headache products are limited to one five (5) day fill within 30 days. Opioid containing headache products are limited to one three (3) day fill within 30 days for less than 18 years of age, an exception is approved as follows: INITIAL CRITERIA [Authorization duration: 3 months]: All of the following: - Diagnosis of one of the following:
- Tension-type or muscular headache
- Migraine headache
- Member is 12 years of age or older
- Inadequate response or inability to tolerate TWO of the following:
- At least two triptans
- Non-steroid anti-inflammatory drugs (e.g., ibuprofen, naproxen)
- Neuroleptics (e.g., prochlorperazine, metoclopramide)
- Dihydroergotamine
REAUTHORIZATION CRITERIA: [Authorization duration: 1 year]: All of the following: - Diagnosis of one of the following:
- Tension-type or muscular headache
- Migraine headache
- Member is 12 years of age or older
- Prescribed by or in consultation with a neurologist or a headache specialist, or pain specialist
- Inadequate response or inability to tolerate NSAIDs
- Ongoing assessment of medication-overuse headache
II. Quantity limit Criteria –
A. Opioid pain products [authorization duration = 1 year] An increased quantity of an opioid medication is approved when there is documentation of ALL of the following:
- Current patient-prescriber opioid treatment agreement (signed within one year of request); and
- The requested dose and frequency do not exceed FDA approved dosing or are supported by compendia; and
- ONE of the following:
- The dose cannot be achieved with commercially available clinical dosage forms; or
- Documentation indicating medical necessity for a quantity that exceeds the plan limit (e.g. GI malabsorption).
B. Cough and cold products [Authorization duration: 1 month for initial; 6 months for reauthorizations] - An increased quantity of an opioid containing cough and cold medication is approved when there is documentation of ALL of the following: - The requested dose and frequency do not exceed FDA approved dosing or are supported by compendia; and
- Documentation of diagnosis requiring long-term therapy with requested cough/ cold medications; and
- Inadequate response or inability to tolerate non-opioid therapies for the indication
C. Butalbital containing headache products [Authorization duration:1 year] - An increased quantity of a butalbital containing headache medication is approved when there is documentation of ALL of the following:
- The requested dose and frequency do not exceed FDA approved dosing or are supported by compendia; and
- Inadequate response or inability to tolerate prophylactic therapy; and
- Prescribed by or in consultation with a neurologist, headache specialist or pain specialist.
D. Buprenorphine/ naloxone (Bunavail®/Suboxone®/Zubsolv®) and buprenorphine sublingual tablet [Authorization duration: 6 months]: buprenorphine/ naloxone or buprenorphine for the treatment of opioid use disorder are approved in quantities greater than those specified in the policy when ALL of the following are met:
- The requested dose and frequency do not exceed FDA approved dosing or are supported by compendia; and
- The dose cannot be achieved with commercially available dosage forms; and
- Inadequate response to lower doses
All products containing the active ingredients in the chart below are subject to the following: - Opioid regimens containing greater than 90 morphine milligram equivalents per day
- Appropriate Utilization with Medication Assistant Treatments (MAT) for opioid use disorder
| Active ingredient | | Benzhydrocodone | Codeine
| | Dihydrocodeine | | Fentanyl | | Hydrocodone | | Hydromorphone | | Levorphanol | | Meperidine | | Methadone | | Morphine | | Opium | | Oxycodone | | Oxymorphone | | Tapentadol | | Tramadol |
The table below identifies medications that are found in the following sections of this policy: - Transmucosal Immediate Release Fentanyl (TIRF) Products (¥ identifies impacted medications)
- Opioid regimens containing greater than 90 morphine milligram equivalents per day, long acting opioids, and short acting low dose opioids for continuation beyond 30days (*identifies impacted long acting opioids)
- Days' Supply and Quantity Limits
| Drug Name | Days' Supply Limit | Maximum Quantity per Day | Quantity limit per rolling 30 days, unless otherwise specified (tablet, capsule) | | Acetaminophen/codeine #2 300/15mg tab | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Acetaminophen/codeine #3 300/30mg tab | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Acetaminophen/codeine #4 300/60mg tab | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Acetaminophen/codeine liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 90mL | | | Benzhydrocodone/acetaminophen (Apadaz®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Buprenorphine film* (Belbuca®) | No | 2 | | | Buprenorphine patch* (Butrans®) | No | | 4 patches | | Buprenorphine sublingual tablet 2mg | No | 4 | | | Buprenorphine sublingual tablet 8mg | No | 3 | | | Buprenorphine/naloxone (Suboxone® 2/0.5mg, 4/1mg) | No | 4 | | | Buprenorphine/ naloxone (Suboxone® 8/2mg) | No | 3 | | | Buprenorphine/ naloxone (Suboxone® 12/3mg) | No | 2 | | | Buprenorphine/naloxone (Zubsolv® 1.4/0.36mg, 2.9-0.71mg) | No | 4 | | | Buprenorphine/naloxone (Zubsolv® 5.7/1.4mg, 0.7/0.18mg) | No | 3 | | | Buprenorphine/naloxone (Zubsolv® 8.6/2.1mg) | No | 2 | | | Buprenorphine/naloxone (Zubsolv® 11.4-2.9mg) | No | 1 | | | Buprenorphine/naloxone 2.1/0.3mg | No | 4 | | | Buprenorphine/naloxone 4.2/0.7mg | No | 3 | | | Buprenorphine/naloxone 6.3/1mg | No | 1 | | | Butalbital/apap (Allzital®) | one 5-day fill per 30 days | 6 | | | Butalbital/apap/caffeine without codeine (Esgic®, Fioricet®) | one 5-day fill per 30 days | 6 | | | Butalbital/apap/caffeine with codeine (Esgic®, Fioricet®/codeine) | one 5-day fill per 30 days for 18 and over; one 3-day fill per 30 days for less than 18 | 6 | | | Butalbital/asa/caffeine without codeine | one 5-day fill per 30 days | 6 | | | Butalbital/asa/caffeine with codeine | one 5-day fill per 30 days for 18 and over; one 3-day fill per 30 days for less than 18 | 6 | | | Carisoprodol/ aspirin/ codeine | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 8 | | | Codeine sulfate tablets 15mg, 30mg | two 5-day fills per 60 for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Codeine sulfate tablets 60mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Codeine/chlorpheniramine (Tuxarin® ER) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 2 | | | Codeine/chlorpheniramine tablets | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 20mL | | | Codeine/ chlorpheniramine solution | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60mL | | | Dihydrocodeine/ acetaminophen/ caffeine (Trezix®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 10 | | | Fentanyl IR¥ (Actiq®, Fentora®) | No | 4 | | | Fentanyl nasal solution¥ | No | 1 | | | Fentanyl patch* | No | | 15 patches | | Guaifenesin/ codeine (Coditussin® AC) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60mL | | | Guaifenesin/ codeine (MAR-COF® CG) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 45mL | | | Guaifenesin/ codeine | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 90mL | | | Hydrocodone bitartrate ER* (Hysingla® ER) | No | 1 | | | Hydrocodone bitartrate ER* | No | 2 | | | Hydrocodone/acetaminophen 2.5/325mg, 5/300mg,7.5/300mg, 5/325mg, 7.5/325mg tab (Xodol®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Hydrocodone/apap 10/325mg, 10/300mg tab (Xodol®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Hydrocodone/apap liquid (10mg/325mg/15ml, 2.5mg/167mg/5ml, 5mg/333mg/10ml, 7.5mg/325mg/15ml, 10mg/300mg/15ml) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 90mL | | | Hydrocodone/chlorpheniramine | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 10mL | | | Hydrocodone/chlorpheniramine | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 2 | | | Hydrocodone/ homatropine (Hydromet®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 30mL | | | Hydrocodone/ homatropine | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Hydrocodone/ibuprofen | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 5 | | | Hydromorphone (Dilaudid®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Hydromorphone 1mg/1ml liquid (Dilaudid®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12mL | | | Hydromorphone extended release* (Exalgo®) | No | 2 | | | Levorphanol tartrate 2mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Levorphanol tartrate 3mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 4 | | | Meperidine 50mg/5ml liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 67mL | | | Meperidine HCL (Demerol®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Methadone* tabs 5mg, 10mg | No | 6 | | | Methadone solution* 5mg/5ml | No | 60mL | | | Methadone solution* 10mg/5ml | No | 30mL | | Methadone solution* (Methadose concentrate,
Methadose sugar-free concentrate) 10mg/1ml | No | 6mL | | | Morphine 10mg/5ml liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 45 mL | | | Morphine 20mg/5ml liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 23 mL | | | Morphine concentrate 20mg/1ml, 10mg/0.5ml, 5mg/0.25ml liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6mL | | | Morphine sulfate IR (MSIR®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Morphine sulfate ER capsules* | No | 1 | | | Morphine sulfate ER capsules* | No | 2 | | | Morphine sulfate SR* | No | 3 | | | Morphine sulfate SR* (MS Contin®) | No | 3 | | | Morphine sulfate/naltrexone* | No | 2 | | | Morphine suppositories 5mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 18 | | | Morphine suppositories 10mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Morphine suppositories 20mg, 30mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Opium tincture | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | N/A | | | Oxycodone 7.5mg tab (Oxaydo®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 8 | | | Oxycodone HCL (Oxy® IR/Roxicodone®/Oxaydo®, Roxybond®) 5mg caps/tabs | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Oxycodone HCL (Oxy® IR/Roxicodone®, Roxybond®), 10mg, 15 mg, 30mg caps/tabs | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Oxycodone 5mg/5ml liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60 mL | | | Oxycodone highly concentrated liquid 20mg/1ml liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6mL | | | Oxycodone HCL ER* (Oxycontin®) | No | 3 | | | Oxycodone ER* (Xtampza® ER) | No | 2 | | | Oxycodone/Acetaminophen, Endocet® (Percocet®, Nalocet®, Prolate®) 2.5/325mg tab, 2.5/300mg tab, 5/300mg, 5/325mg tab | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Oxycodone/Acetaminophen (Prolate®) 7.5/300mg tab, 10/300mg tab | two 5-day fills
per 60 days for
18 and older;
two 3-day fills
per 60 days for
less than 18 | 6 | | | Oxycodone/acetaminophen 7.5/325mg tab (Endocet®/Percocet®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 8 | | | Oxycodone/acetaminophen 10/325mg tab (Endocet®/Percocet®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Oxycodone/acetaminophen 5mg/325mg/5ml liquid | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60 | | | Oxycodone/aspirin 4.8355/325mg tab | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 12 | | | Oxycodone/Acetaminophen (Prolate®) 10-300mg/5ml soln | Two 5-days fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 30 ml | | | Oxymorphone HCL | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Oxymorphone HCL ER* | No | 3 | | | Phenylephrine/ brompheniramine/ codeine | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 90mL | | | Phenylephrine/ chlorpheniramine/ codeine (Capcof®) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60mL | | | Phenylephrine/ dexchlorpheniramine/ codeine (Pro-red® AC) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60mL | | | Promethazine/codeine 6.25-10mg/5mL syrup | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 30mL | | | Pseudoephedrine/ brompheniramine/ codeine (MAR-COF® BP) | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60mL | | | Pseudoephedrine/codeine/ guaifenesin solution 30-10-100 MG/5ML | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 40mL | | | Pseudoephedrine/ dexbrompheniramine/ codeine | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 60mL | | | Tapentadol (Nucynta®) 50mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 4 | | | Tapentadol (Nucynta®) 75mg, 100mg | two 5-day fills per 60 days for 18 and older; two 3-day fills per 60 days for less than 18 | 6 | | | Tapentadol ER* (Nucynta® ER) | No | 2 | | | Tramadol 50mg, 25mg | | 8 | | | Tramadol (Conzip®) | | 1 | | | Tramadol/acetaminophen | | 8 | | | Tramadol/celecoxib (Seglentis®) | No | 4 | | | Tramadol 100 mg | | 4 | | | Tramadol (Qdolo®) | | 80ml | |
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| 1. Respiratory depression: 21, 22, 30, 31, 32, 33, 34, 35, 40, 43 TIRFs (Actiq®, Fentora®, Subsys®), Lazanda®, Duragesic®, Hydromorphone (Dilaudid, Exalgo®), Methadone, Morphine Sulfate: ArymoTM ER, Avinza®, Kadian®, and MS Contin®, Morphabond ER®, Nucynta ER®/ Opana ER®, Oxycodone (Oxycontin®, oxycodone concentrate, OxaydoTM, Roxybond®), Zohydro ER™ (hydrocodone ER), Buprenorphine (Belbuca and Butrans), benzhydrocodone/acetaminophen (Apadaz®), codeine polistirex and chlorpheniramine (Tuzistra XR), codeine phosphate and chlorpheniramine maleate (Tuxarin®), levorphanol, Qdolo® (tramadol), Seglentis® (tramadol/celecoxib) Fatal respiratory depression has occurred in patients treated with the above listed opioid products, including following use in opioid-intolerant patients and improper dosing. Be sure to monitor for sign and symptoms of respiratory depression, especially during initiation of the drugs. The substitution of fentanyl sublingual/buccal for any other fentanyl product may result in fatal overdose. Because of the risk of respiratory depression, fentanyl products are contraindicated for use as an as-needed analgesic, or in the management of acute or postoperative pain, including headache/migraine and in opioid-intolerant patients. In addition, the concomitant use of fentanyl sublingual with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.For hydromorphone and ER products like morphine ER, oxycodone ER, hydrocodone ER, tapentadol ER, and oxymorphone ER products, instruct patients to swallow a whole tablet. Crushing, chewing, snorting, or dissolving tablets can cause rapid release and absorption that could lead to fatal overdose and even death. Note: Avinza® capsule contents may be sprinkled on applesauce and swallowed without chewing19. Hydromorphone is a potent Schedule II controlled opioid agonist. Schedule II opioid agonists have the highest potential for abuse and risk of producing respiratory depression. Alcohol, other opioids, and CNS depressants (sedative-hypnotics) potentiate the respiratory depressant effects of hydromorphone, increasing the risk of respiratory depression that might result in death. 2. Medication errors: 32, 33 TIRFs (Actiq®, Fentora®, Subsys®), Lazanda®, codeine phosphate and chlorpheniramine maleate (Tuxarin®), codeine polistirex and chlorpheniramine (Tuzistra XR), Qdolo® (tramadol)
Substantial differences exist in the pharmacokinetic profile of fentanyl sublingual/buccal compared with other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose. When prescribing, do not convert patients on a mcg-per-mcg basis from any other fentanyl products to fentanyl sublingual/buccal. When dispensing, do not substitute a fentanyl sublingual/buccal prescription for other fentanyl products.
3. Addiction and Abuse potential: 21, 22, 30, 31, 32, 33, 34, 42, 43 TIRFs (Actiq®, Fentora®, Subsys®), Lazanda®, Duragesic®, Hydromorphone (Dilaudid, Exalgo®), Methadone, Morphine Sulfate: ArymoTM ER, Avinza®, Kadian®, and MS Contin®, Morphabond ER®, Nucynta ER®/ Opana ER®, Oxycodone (Oxycontin®, oxycodone concentrate, OxaydoTM, Roxybond®), Zohydro ER™ (hydrocodone ER), Buprenorphine (Belbuca and Butrans), benzhydrocodone/acetaminophen (Apadaz®), codeine phosphate and chlorpheniramine maleate (Tuxarin®), codeine polistirex and chlorpheniramine (Tuzistra XR), levorphanol, Qdolo® (tramadol), Seglentis® (tramadol/celecoxib) All opioid analgesics regardless of formulation are classified as Schedule II controlled substance, with high abuse liability. They expose patients and drug users to the risk of opioid addiction, abuse, and misuse, which can lead to overdose and death. Diversion, addiction, and abuse potential should be considered when prescribing or dispensing opioid analgesics. Providers must monitor all patients regularly for the development of these behaviors or conditions. Due to the risk for misuse, abuse, addiction, and overdose, some products such as fentanyl sublingual/buccal is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program, outpatients, health care providers who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at http://www.TIRFREMSaccess.com or by calling 1-866-822-1483. 4. Cytochrome P450 3A4 interaction: 30, 31 TIRFs (Actiq®, Fentora®, Subsys®), Lazanda®, Duragesic®, Oxycodone (Oxycontin®, oxycodone concentrate, OxaydoTM ,Roxybond®), Zohydro ER™ (hydrocodone ER), benzhydrocodone/acetaminophen (Apadaz®), codeine polistirex and chlorpheniramine (Tuzistra XR), codeine phosphate and chlorpheniramine maleate (Tuxarin®), Qdolo® (tramadol), Seglentis® (tramadol/celecoxib)
The concomitant use of fentanyl, oxycodone ER and hydrocodone ER with all cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone ER and any CYP3A4 inhibitor or inducer.
5. Accidental exposure 21, 22, 30, 31, 32, 33, 34, 42, 43: Duragesic®, Hydromorphone (Dilaudid, Exalgo®), Methadone, Morphine Sulfate: ArymoTM ER, Avinza®, Kadian®, and MS Contin®, Morphabond ER® , Nucynta ER®/ Opana ER®, Oxycodone (Oxycontin®, oxycodone concentrate, OxaydoTM Roxybond®), Zohydro ER™, Buprenorphine (Belbuca and Butrans), benzhydrocodone/acetaminophen (Apadaz®), codeine polistirex and chlorphniramine (Tuzistra XR), codeine phosphate and chlorpheniramine maleate (Tuxarin®), levorphanol, Qdolo® (tramadol), Seglentis® (tramadol/celecoxib)
Deaths due to a fatal overdose of the above listed opioid analgesics have occurred when children and adults were accidentally exposed to the drugs. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure. Accidental ingestion of even 1 dose, especially in children, can result in a fatal overdose and death.
6. Neonatal opioid withdrawal syndrome: 21, 22, 30, 31, 32, 33, 34, 44, 43
Prolonged use of opioid analgesics especially Duragesic®, Hydromorphone (Dilaudid, Exalgo®), Methadone, Morphine Sulfate: ArymoTM ER, Avinza®, Kadian®, and MS Contin®, Morphabond ER® , Nucynta ER®/ Opana ER® (tapentadol ER, and oxymorphone ER), Zohydro ER™, Oxycodone (Oxycontin®, oxycodone concentrate, OxaydoTM, Roxybond®), Buprenorphine (Belbuca and Butran), benzhydrocodone/acetaminophen (Apadaz®), codeine phosphate and chlorpheniramine maleate (Tuxarin®), codeine polistirex and chlorpheniramine (Tuzistra XR), Qdolo® (tramadol), levorphanol , Seglentis® (tramadol/celecoxib)can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
7. Exposure to heat: Duragesic® (31)
Exposure of the fentanyl application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl and death. Patients wearing fentanyl systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of fentanyl to avoid overdose and death.
8. Life-threatening QT prolongation: Methadone 29
QT interval prolongation and serious arrhythmia like torsades de pointes have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of methadone. 9. Treatment of opioid addiction: Methadone29
For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration. 10. Interaction with alcohol 21, 22, 30, 31, 32, 33, 34, 35, 40: Morphine Sulfate: Avinza®, Kadian®, and MS Contin®, Nucynta ER®/ Opana ER®, Zohydro ER™, Oxycodone (Oxycontin®, oxycodone concentrate, OxaydoTM, Roxybond®), Buprenorphine (Belbuca and Butran), benzhydrocodone/acetaminophen (Apadaz®)
When using with alcohol, all opioid analgesic products have the potential to cause excessive sedation and may increase blood concentration of certain opioids like tapentadol, oxymorphone, and morphine. This could lead to fatal overdose and death. Instruct patients to avoid alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking opioid analgesics.
11. Information about oral morphine and oxycodone solution23, 29 : Morphine Sulfate: Avinza®, Kadian®, and MS Contin®, Oxycodone (Oxycontin®, oxycodone concentrate, OxaydoTM, Roxybond®)
Morphine oral solution is available in 10 mg per 5 mL, 20 mg per 5 mL, and 100 mg per 5 mL (20 mg/mL) concentrations. The 100 mg per 5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care when prescribing and administering morphine oral solution to avoid dosing errors due to confusion between different concentrations and between milligrams and milliliters, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. Keep morphine oral solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.
Oxycodone concentrated oral solution is available as a 20 mg/mL concentration and is indicated for use in opioid-tolerant patients only. Take care when prescribing and administering oxycodone concentrated oral solution to avoid dosing errors due to confusion between milligram and milliliter, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. Keep oxycodone out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.
12. Abuse Deterrent Technology: Oxaydo™ (37)
This formulation incorporates Acura's patented AVERSION® (abuse-deterrent) Technology which Acura states is a patented mixture of gelling ingredients and nasal irritants designed to address common forms of opioid abuse. OXAYDO can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing in situations where there is concern about an increased risk of misuse or abuse. OXAYDO may be abused by crushing, chewing, snorting or injecting the product and these practices pose a significant risk to the abuser that could result in overdose and death.
A Risk Evaluation and Mitigation Strategy (REMS) is included in the label of the several medications. A REMS is a safety strategy to manage known or potential serious risks associated with a medication and to enable patients to have continued access to such medicines by managing their safe use. Refer to the individual product labels for details on the REMS programs.
13. Risks from Concomitant Use with Benzodiazepines or other CNS Depressants: ArymoTM ER 42, Morphabond ER® 43, benzhydrocodone/acetaminophen (Apadaz®), codeine polistirex and chlorphniramine (Tuzistra XR), codeine phosphate and chlorpheniramine maleate (Tuxarin®), levorphanol, Qdolo® (tramadol), Seglentis® (tramadol/celecoxib) Concomitant use of opioid with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depressions, coma, and death. 14. Life threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. TUXARIN ER, TUZISTRA XR are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of TUXARIN ER, TUZISTRA XR for adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
Life-threatening respiratory depression and death have occurred in children who received Qdolo® (tramadol). Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. Qdolo® is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of Qdolo® in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol. 15. Hepatotoxicity: benzhydrocodone/acetaminophen (Apadaz®) APADAZ contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
16. Cardiovascular thrombotic events (Seglentis®)
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. SEGLENTIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
17. Gastrointestinal bleeding, ulceration, and perforation (Seglentis®)
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events.
18. Ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children (Seglentis®)
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. SEGLENTIS is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of SEGLENTIS in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
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Schumacher MA, Basbaum AI, Naidu RK. Opioid Agonists & Antagonists. In: Katzung BG. eds. Basic & Clinical Pharmacology, 14e New York, NY: McGraw-Hill; . http://accesspharmacy.mhmedical.com.libproxy.temple.edu/content.aspx?bookid=2249§ionid=175220393. Accessed August 4, 2024. Herndon CM, Strickland JM, Ray JB. Pain Management. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY: McGraw-Hill; http://accesspharmacy.mhmedical.com.libproxy.temple.edu/content.aspx?bookid=1861§ionid=146063604. Accessed August 4, 2024. Franklin, Gary M. Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology. Neurology 2014; 83; 1277-1284. 2014. https://doi.org/10.1212/WNL.0000000000000839. Accessed August 4, 2024. American Pain Society. Pain: Current Understanding of Assessment, Management, and Treatments. Available at https://www.npcnow.org/system/files/research/download/Pain-Current-Understanding-of-Assessment-Management-and-Treatments.pdf. Accesed August 4, 2024. World Health Organization. Definition of palliative care. 2019 Available at http://www.who.int/cancer/palliative/definition/en/ . Accessed August 4, 2024. Eilers H, Yost S. General Anesthetics. In: Katzung BG. eds. Basic & Clinical Pharmacology, 14e New York, NY: McGraw-Hill; . http://accesspharmacy.mhmedical.com.libproxy.temple.edu/content.aspx?bookid=2249§ionid=175219294. Accessed August 4, 2024. Taylor FR. Tension-type headache in adults: Pathophysiology, clinical features, and diagnosis. UpToDate November 2018. Available at: https://www.uptodate.com/contents/tension-type-headache-in-adults-pathophysiology-clinical-features-and-diagnosis. Accessed August 4, 2024. Minor DS, Harrell T. Headache Disorders. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY: McGraw-Hill; . http://accesspharmacy.mhmedical.com.libproxy.temple.edu/content.aspx?bookid=1861§ionid=146063736. Accessed August 4, 2024. Berry PH, Covington EC, Dahl JL, et al. Editorial Advisory Board. Pain: Current Understanding of Assessment, Management, and Treatments. Continuing Education Sponsored by the American Pain Society and supported by Unrestricted Education Grant from the National Pharmaceutical Council, Inc. Release June 2006. Available at: hepmp.med.bg.ac.rs/wp-content/uploads/2019/04/Pain-Current-Understanding-of-Assessment-Management-and-Treatments.pdf Portenoy RK, Mehta Z, Ahmed E. Cancer pain management: general principals and risk management for patients receiving opioids. UpToDate. November 2020. Available at: https://www.uptodate.com/contents/cancer-pain-management-general-principles-and-risk-management-for-patients-receiving-opioids?source=search_result&search=pain%20management&selectedTitle=25~150. Accessed August 4, 2024. Opioid Oral Morphine Milligram Equivalent (MME) Conversion Factors. Available from: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-Aug-2017.pdf Accessed August 4, 2024. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. JAMA. 2016;315(15):1624-1645. doi:10.1001/jama.2016.1464 Exalgo® [prescribing information]. Webster Groves, MO. MallinckrodtTM; Revised June 2020. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=22e635cb-98c0-e4f9-6a71-62d7487a0a6c&type=display. Accessed August 4, 2024. American Board of Anesthesiology- Pain Management: http://directory.theaba.org/default.aspx. Accessed April 01, 2022. American Board of Psychiatry & Neurology- Pain Management: https://application.abpn.com/verifycert/verifycert.asp. Accessed August 4, 2024. American Board of Physical Medicine & Rehabilitation- Pain Management: https://www.abpmr.org/physician_search.html. Accessed August 4, 2024. American Osteopathic Association- Pain Management: http://www.osteopathic.org/Pages/default.aspx. Accessed August 4, 2024. Morphine ER Capsules – Actavis Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=6fe62c06-5bab-4fc8-b546-ff015a1fc40c. Accessed August 4, 2024. Morphine ER Tablets – Mallinckrodt Medication Guide. Available at file:///C:/Users/i326548/AppData/Local/Packages/Microsoft.MicrosoftEdge_8wekyb3d8bbwe/TempState/Downloads/morphertabs-l20m55-mg-072017-1%20(1).pdf. Accessed August 4, 2024. Morphine Oral Solution – Lannett Medication Guide. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201517s005medg.pdf. Accessed August 4, 2024. Morphine Sulfate ER Capsules – Upsher-Smith Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=97948a8f-7d1b-4614-b11d-e944cf56590b. Accessed August 4, 2024. Morphine Sulfate ER Tablets – Mylan Medication Guide. Morphine Sulfate ER Tablets- Mylan Medication Guide. Available at http://medlibrary.org/lib/rx/meds/morphine-sulfate-41. Accessed August 4, 2024. Morphine Sulfate ER Tablets – Rhodes Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804. Accessed August 4, 2024. Morphine Sulfate Oral Solution – VistaPharm Medication Guide. Available at http://medlibrary.org/lib/rx/meds/morphine-sulfate-25/. Accessed August 4, 2024. MS Contin (morphine sulfate) Medication Guide. Available at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311374.pdf. Accessed August 4, 2024. US Food and Drug Administration (FDA): FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes. US Food and Drug Administration (FDA). Silver Spring, MD. 2016. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm489676.htm. Accessed August 4, 2024. Oxycodone Oral Solution – VistaPharm Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=d7dceba3-96dc-4593-bc8f-318052bdb520. Accessed August 4, 2024. Fentanyl TD Patch – Novaplus Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=9baf2912-9d0f-412a-8fbf-617f6a4f91ed. Accessed August 4, 2024. Fentanyl Transdermal Patch – Par Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=245a75e6-3b45-4dc6-bc58-2e33196faca0. Accessed August 4, 2024. Fentanyl Transdermal Patch – Upsher-Smith Medication Guide. Available at https://online.lexi.com/lco/medguides/604925.pdf. Accessed August 4, 2024. Buprenorphine/Naloxone Sublingual Tablets – Actavis Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=6cccf229-9611-4b6f-8f1b-acc8ff1ed3f8. Accessed August 4, 2024. Buprenorphine/Naloxone Sublingual Tablets – Amneal Medication Guide. Available at https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=17b63f10-c9df-44be-80fa-6f1c305583b8. Accessed August 4, 2024. Suboxone®(buprenorphine/naloxone) [prescribing information]. North Chesterfield, VA: Indivior Inc.; October 2019. Available at https://www.suboxone.com/pdfs/prescribing-information.pdf. Accessed August 4, 2024. Oxaydo® (oxycodone) [package insert]. Wayne, PA: Egalet US Inc., October 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=cff0c64a-63f5-4b3c-909a-cdecf6755cbe&type=display. Accessed August 4, 2024. BelbucaTM (buprenorphine) [package insert]. Raleigh, NC: BioDelivery Sciences International, Inc. July 2020. Available at: https://s3.amazonaws.com/belbuca/website/pdfs/belbuca-prescribing-info.pdfAccessed August 4, 2024. Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-term Opioid Use, Unites States, 2006-2015. Available at: https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm?s_cid=mm6610a1_w. Accessed August 4, 2024. Weinberger SE, Silvestri RC. Treatment of subacute and chronic cough in adults. UpTodate. October 2018. Available at: https://www.uptodate.com/contents/treatment-of-subacute-and-chronic-cough-in-adults?search=cough%20adult&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2. Accessed August 4, 2024. Cunningham C, et al. The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder. 2020. Available at: https://www.asam.org/docs/default-source/quality-science/npg-jam-supplement.pdf?sfvrsn=a00a52c2_2. August 4, 2024. Prescription Drug Coverage Contracting, Centers for Medicare & Medicaid Services (CMS). Opioid Oral Morphine Milligram Equivalent (MME) Conversion Factors. February 2018. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-vFeb-2018.pdf. Accessed August 4, 2024. Roxybond® (oxycodone hydrochloride) [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc. February 2022. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf. Accessed August 4, 2024. Levorphanol [prescribing information]. Solana Beach, CA: Sentynl Therapeutics, Inc. October 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77f4a54a-6901-46d9-93db-ad4be7eae6c3. Accessed August 4, 2024. Tuxarin® (codeine phosphate and chlorpheniramine maleate) [package insert]. Irvine, CA: Nexgen Pharma, Inc. June 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf. Accessed August 4, 2024. Apadaz® (benzhydrocodone and acetaminophen) [prescribing information]. Coralville, IA: KemPharm, Inc. October 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf. Accessed August 4, 2024. Qdolo® (tramadol). Athena Bioscience, Inc. September 2020. Available at: https://qdolo.com/wp-content/uploads/2020/10/QDOLO-Prescribing-Information.pdf. Accessed August 4, 2024. Seglentis® (tramadol/celecoxib) [package insert]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213426s000lbl.pdf. Accessed August 4, 2024
| 23 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:16 AM | srv_ppsgw_P | Rx.01.202 Prior Authorization Requirements for Select Drugs
Rx.01.33 Off-Label Use
| Refer to table in the policy section.
| N/A | N/A | | 463 | | | 10/1/2024 | Rx.01.66 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | BEDAQUILINE (SIRTURO®) Bedaquiline (Sirturo®) is indicated as part of combination therapy in adults and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve Sirturo® for use when an effective treatment regimen cannot otherwise be provided Bedaquiline (Sirturo®) is a diarylquinoline antimycobacterial drug that inhibits mycobacterial ATP synthase, an enzyme that is essential for the generation of energy in Mycobacterium tuberculosis. ISAVUCONAZONIUM (CRESEMBA®)
Isavuconazonium (Cresemba®) is indicated for the treatment of invasive aspergillosis and invasive mucormycosis. Isavuconazonium (Cresemba®) is the prodrug of isavuconazole, an azole antifungal. Isavuconazole inhibits the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14-alpha-demethylase. This enzyme is responsible for the conversion of lanosterol to ergosterol. An accumulation of methylated sterol precursors and a depletion of ergosterol within the fungal cell membrane weakens the membrane structure and function. TEDIZOLID (SIVEXTRO®) Tedizolid (Sivextro®) is indicated for the treatment of adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
Tedizolid (Sivextro®) binds to the 50S bacterial ribosomal subunit. This prevents the formation of a functional 70S initiation complex that is essential for the bacterial translation process and subsequently inhibits protein synthesis. Tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci.
PRETOMANID Pretomanid is indicated for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) as part of a combination regimen with bedaquiline and linezolid. Pretomanid is indicated for use in a limited and specific population of patients Pretomanid is a nitroimidazooxazine antimycobacterial drug. Pretomanid kills actively replicating M. tuberculosis by inhibiting mycolic acid biosynthesis, thereby blocking cell wall production. Under anaerobic conditions, against non-replicating bacteria, Pretomanid acts as a respiratory poison following nitric oxide release. OMADACYCLINE (NUZYRA®) NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: - Community-acquired bacterial pneumonia (CABP)
- Acute bacterial skin and skin structure infections (ABSSSI)
| The intent of this policy is to communicate the medical necessity criteria for bedaquiline (Sirturo®), isavuconazonium (Cresemba®), tedizolid (Sivextro®), omadacycline (Nuzyra®) and pretomanid as provided under the member's prescription drug benefit.
| BEDAQUILINE (SIRTURO®) Bedaquiline (Sirturo®) is approved when ALL of the following are met: - Diagnosis of pulmonary multi-drug resistant tuberculosis (MDR-TB), for which an effective treatment regimen cannot otherwise be established; and
- Member is 5 years of age or older and weighing at least 15kg; and
- Prescribed by or in consultation with an infection disease specialist or pulmonologists; and
- Bedaquiline is used as combination therapy as defined by ONE of the following:
- With at least 3 other drugs to which the member's MDR-TB isolate has been shown to be susceptible in vitro; or
- With at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible
Authorization duration: 24 weeks
ISAVUCONAZONIUM (CRESEMBA®)
Isavuconazonium (Cresemba®) is approved when ALL of the following are met:
- Member is 18 years of age or older; and
- Prescribed by or in consultation with an infectious diseases specialist; and
- Diagnosis of ONE of the following:
- Treatment of invasive aspergillosis and inadequate response or inability to tolerate voriconazole; or
- Treatment of invasive mucormycosis
Authorization duration: 12 months
TEDIZOLID (SIVEXTRO®)
Tedizolid (Sivextro®) is approved when ALL of the following are met:
- Member is 12 years of age or older; and
- Prescribed by or in consultation with an infectious diseases specialist; and
- Documentation of use for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Gram-positive microorganisms and ONE of the following:
- Inadequate response or inability to tolerate ALL antibiotics to which the organism is susceptible; or
- Tedizolid is the only antibiotic to which the organism is susceptible; or
- There is a contraindication to using an alternative antibiotic to which the organism is susceptible to (e.g., drug-drug interaction concern with the alternative antibiotic and member's existing drug regimen)
Authorization duration: 4 weeks PRETOMANID Pretomanid is approved when ALL of the following are met: - Diagnosis of pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB); and
- Medication will be used as part of combination regiment with bedaquiline (Sirturo®) and linezolid; and
- Member is 18 years of age or older; and
- Prescribed by or in consultation with an infectious disease specialist
Authorization duration: 26 weeks
OMADACYCLINE (NUZYRA®) Omadacycline (Nuzyra®) is approved when ALL of the following are met: - Member is 18 years of age or older; and
- Prescribed by or in consultation with an infectious disease specialist; and
- One of the following:
- Documentation of use for the treatment of community-acquired bacterial pneumonia; or
- Documentation of use for the treatment of acute bacterial skin and skin structure infections (ABSSSI); and
- ONE of the following:
- Inadequate response or inability to tolerate ALL antibiotics to which the organism is susceptible; or
- Omadacycline is the only antibiotic to which the organism is susceptible; or
- There is a contraindication to using an alternative antibiotic to which the organism is susceptible to (e.g., drug-drug interaction concern with the alternative antibiotic and member's existing drug regimen)
Authorization duration: 4 weeks
| BEDAQUILINE (SIRTURO®)
An increased risk of death was seen in the bedaquiline group (11.4%) compared with the placebo group (2.5%) in 1 placebo-controlled trial. Only use SIRTURO in patients 5 years of age and older when an effective treatment regimen cannot otherwise be provided..
QT prolongation can occur with bedaquiline. Use with drugs that prolong the QT interval may cause addictive QT prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTcF interval >500 ms develops.
| | Pretomanid [prescribing information]. India: Mylan, Laboratories Limited; April 2019. Available from: https://www.tballiance.org/sites/default/files/assets/Pretomanid_Full-Prescribing-Information.pdf. Accessed August 4, 2024
Cresemba® (isavuconazonium) [package insert]. Northbrook, IL. Astellas Pharma US. December 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8f7f73b8-586a-4df0-935f-fecd4696c16c&type=display. Accessed August 4, 2024
Sirturo® (bedaquiline) [package insert]. Janssen Therapeutics; Titusville, NJ. October 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e&type=display. Accessed August 4, 2024
Sivextro® (tidizolid) [package insert]. White House Station, NJ: Merc and Co, Inc. March 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=75672079-589f-451a-bdbf-eaebcfcc80a9&type=display. Accessed August 4, 2024
Nuzyra® (omadacycline) [package insert]. Boston, MA: Paratek Pharmaceutical, Inc. May 2021. Available at: https://www.nuzyra.com/nuzyra-pi.pdf. Accessed August 4, 2024
| 24 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:16 AM | srv_ppsgw_P | Rx.01.33 Off Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Cresemba® | isavuconazonium | | Sirturo® | bedaquiline | | Sivextro® | tedizolid | | | Pretomanid | | Nuzyra® | omadacycline |
| NA | NA | | 464 | | | 10/1/2024 | Rx.01.272 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Vulvovaginal candidiasis (VVC) is one of the most common causes of vulvovaginal itching and discharge. The disorder is characterized by inflammation in the setting of Candida species. Treatment is indicated for the relief of symptoms. Recurrent vulvovaginal candidiasis (RVVC) is defined as three or more episodes of symptomatic infection within one year.
Oteseconazole is an antifungal drug. It is an azole metalloenzyme inhibitor that inhibits the enzyme CYP51 (also known as 14α demethylase). It demethylates the 14-α position of lanosterol to yield ergosterol, a compound that plays a key role in maintaining the integrity of cell membranes in yeast and fungi, thereby inhibiting fungal growth.
Vivjoa™ is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
| The intent of this policy is to communicate the medical necessity criteria for oteseconazole (Vivjoa™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Oteseconazole (Vivjoa™) is approved when ALL of the following are met: - Diagnosis of recurrent vulvovaginal candidiasis (RVVC); and
- Member is not of reproductive potential; and
- Diagnosis of RVVC is confirmed by ONE of the following:
- Positive potassium hydroxide (KOH) preparation; or
- Vaginal fungal culture; and
- Member has experienced 3 or more symptomatic episodes of vulvovaginal candidiasis (VVC) within the past 12 months; and
- Inadequate response or inability to tolerate BOTH of the following:
- One intravaginal product (e.g., clotrimazole, miconazole, terconazole); and
- Oral fluconazole
Authorization duration: 4 months
| | | Sobel J. Candida vulvovaginitis: Treatment. UpToDate. Revised December 2022. Available from: uptodate.com. Accessed August 4, 2024
VivjoaTM (oteseconazole) [package insert]. Durham, NC: Mycovia Pharmaceuticals, Inc; April 2022. Available at https://vivjoa.com/pi/VIVJOA-Full-Prescribing-Information.pdf. Accessed August 4, 2024
| 2 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:17 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Vivjoa | oteseconazole |
| NA | NA | | 465 | | | 10/1/2024 | Rx.01.240 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Blepharoptosis, or ptosis of the eyelid, refers to drooping of the upper eyelid that usually results from a congenital or acquired abnormality of the muscles that elevate the eyelid. Ptosis may be the presenting sign or symptom of serious neurologic disease. Depending on the degree of ptosis, presenting symptoms may range from an asymptomatic subtle cosmetic defect to significant visual deficits. Standard of care is surgery. While effective in improving visual function and quality-of-life measures, there are risks associated with surgical intervention. The Müller muscle, an accessory smooth muscle, maintains upper eyelid elevation and is innervated by the sympathetic nervous system. Therefore, the Müller muscle is a common surgical and pharmacological target. Oxymetazoline is an alpha adrenoceptor agonist targeting a subset of adrenoreceptors in Mueller's muscle of the eyelid. Oxymetazoline (Upneeq™) is indicated for the treatment of acquired blepharoptosis in adults. Oxymetazoline (Upneeq™), when used solely to change the appearance of any portion of the face, without improving the physiologic functioning of that portion of the body, is considered cosmetic use.
| The intent of this policy is to communicate the medical necessity criteria for Oxymetazoline (Upneeq™) as provided under the member's prescription drug benefit.
| INITAL CRITERIA: Oxymetazoline (Upneeq™) is approved when ALL of the following are met: - Diagnosis of acquired blepharoptosis; and
- Request is not for an excluded benefit (i.e. cosmetic - solely for lifting the eyelid to improve appearance); and
- Member has obstructed visual field in primary gaze or down gaze due to blepharoptosis; and
- One of the following:
- Marginal reflex distance-1 (MRD-1) is less than or equal to 2mm in primary gaze; or
- Marginal reflex distance-1 (MRD-1) is less than or equal to 2mm in down gaze; or
- Superior visual field loss of at least 12 degrees or 24 percent; and
- Other treatable causes of blepharoptosis have been ruled out (e.g., recent botulinum toxin injection, myasthenia gravis); and
- Prescribed by or in consultation with an ophthalmologist or optometrist
Initial authorization duration: 3 months
REAUTHORIZATION CRITERIA: Oxymetazoline (Upneeq™) is re-approved when BOTH of the following are met: - Documentation of positive clinical response to therapy (e.g., improvement in superior visual field, increase in Marginal reflex distance-1 [MRD-1]); and
- One of the following:
- Marginal reflex distance-1 (MRD-1) is less than or equal to 2mm in primary gaze; or
- Marginal reflex distance-1 (MRD-1) is less than or equal to 2mm in down gaze; or
- Superior visual field loss of at least 12 degrees or 24 percent
Reauthorization duration: 12 months
| | | Upneeq™ (oxymetazoline hydrochloride ophthalmic solution) [prescribing information]. Bridgewater, NJ: RVL Pharmaceuticals, Inc; May 2023. Available from: https://www.upneeq.com/Upneeq-PI.pdf. Accessed August 4, 2024 Slonim CB, Foster S, Jaros M, et al. Association of Oxymetazoline Hydrochloride, 0.1%, Solution Administration With Visual Field in Acquired Ptosis: A Pooled Analysis of 2 Randomized Clinical Trials [published online ahead of print, 2020 Oct 1]. JAMA Ophthalmol. 2020;138(11):1168-1175. doi:10.1001/jamaophthalmol.2020.3812 Lee, MS. Overview of ptosis. UpToDate Web site. March 2023. www.uptodate.com. Accessed August 4, 2024
| 4 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:17 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Upneeq™ | Oxymetazoline hydrochloride |
| NA | NA | | 466 | | | 10/1/2024 | Rx.01.261 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | The normal eye creates a clear image by bending (refracting) light in order to focus it onto the retina. Refractive errors occur when a component of the eye's optical system fails to focus the optical image. Presbyopia ("aging sight") is a non-refractive error that also affects visual acuity. Presbyopia occurs when the lens loses its normal accommodating power and can no longer focus on objects viewed at arm's length or closer. Approximately 128 million adults in the United States are living with presbyopia. Presbyopia has traditionally been treated with corrective lenses or surgery. Pilocarpine (Vuity™) is indicated for the treatment of presbyopia in adults. Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. Vuity contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. Vuity also contracts the ciliary muscle and may shift the eye to a more myopic state.
| The intent of this policy is to communicate the medical necessity criteria for Pilocarpine (Vuity™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Pilocarpine (Vuity™) is approved when ALL of the following are met: - Diagnosis of presbyopia; and
- Prescribed by or in consultation with ONE of the following:
- Ophthalmologist; or
- Optometrist; and
- Member is unable to use corrective lenses (e.g., eyeglasses or contact lenses)
Initial authorization duration: 1 month
REAUTHORIZATION CRITERIA: Pilocarpine (Vuity™) is re-approved when BOTH of the following are met:
- Documentation of positive clinical response to therapy (e.g., improvement in near vision in low light conditions without loss of distance vision); and
- Prescribed by or in consultation with one of the following:
- Ophthalmologist; or
- Optometrist
Reauthorization duration: 6 months
| | | | 3 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:17 AM | srv_ppsgw_P | | | NA | NA | | 467 | | | 10/1/2024 | Rx.04.5 | Claim Payment Policy | Oyenusi, Oluwadamilola | Q2-2024 | A dietary supplement is defined by the Food and Drug Administration as "a product intended for ingestion that contains a 'dietary ingredient' intended to add further nutritional value to (supplement) the diet. A 'dietary ingredient' may be one, or any combination, of the following substances: - a vitamin
- a mineral
- an herb or other botanical
- an amino acid
- a dietary substance for use by people to supplement the diet by increasing the total dietary intake
- a concentrate, metabolite, constituent, or extract"
The US Food and Drug Administration (FDA) defines a medical food as a "food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." FDA section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)). The FDA further defines medical foods as "foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition's specific dietary management." Medical foods are "intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone." They also "provide nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation." Current benefit language states the plan will not cover: - Dietary supplements
- Amino acid supplements
- Medical foods (exceptions may apply; refer to benefit language for details)
- Prescription vitamins except for pre-natal and pediatric vitamins
| The intent of this policy is to communicate the coverage of prescription vitamins, dietary supplements, and medical foods under the member’s prescription drug benefit.
| Coverage is subject to the terms, conditions, and limitations of the member's contract. Prescription vitamins, dietary supplements, and medical foods are not covered under the pharmacy benefit. An exception to allow coverage under the member's plan will be in place for prescription medication that are either mandated when used as a preventive medication as described in the Patient Protection and Affordable Care Act (PPACA) or medically necessary for the treatment of a specific illness as determined by the plan. The following prescription products are covered under the member's prescription benefit: | Products | Clinical Use | | Calcitriol oral | Management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (creatinine clearance 15 to 55 mL/min) not yet on dialysis. | | Cholecalciferol (vitamin D3) 50,000 units | Treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. This is an over the counter preparation included to meet essential health benefit requirements. | | Cyanocobalamin inhaled | Maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular (IM) vitamin B12 therapy and who have no nervous system involvement | | Dialysis vitamins oral as identified by indication in product label | Wasting syndrome in chronic renal failure, uremia, and impaired metabolic function of the kidney | | Doxercalciferol oral | Secondary hyperparathyroidism (dialysis patients): Treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Secondary hyperparathyroidism (predialysis patients): Treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease. | | Ergocalciferol oral | Treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. | | Paricalcitol oral | Hyperparathyroidism: For the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease stage 3 and 4, and chronic kidney disease stage 5 in patients on hemodialysis or peritoneal dialysis. | | Pediatric vitamins | Nutritional supplement for children | | Phytonadione oral | Anticoagulant-induced prothrombin deficiency caused by coumarin or indandione derivatives.
Coagulation disorders: Phytonadione is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. | | Potassium aminobenzoate oral | The treatment of scleroderma, dermatomyositis, morphea, linear scleroderma, pemphigus, and Peyronie's disease. | | Prenatal vitamins | Nutritional supplement used prior to conception, during pregnancy, and in the postnatal period | | Prescription electrolytes | Electrolyte repleters (i.e., potassium) and electrolyte depleters (i.e., calcium acetate) |
| | | | 10 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:17 AM | srv_ppsgw_P | Formulary Exception policy Rx.06.61 Medical Foods (ie, Enteral Nutrition and Nutritional Formulas) and Low-Protein Modified Food Products 08.00.18j Non-FDA Approved Products Rx.04.2 Off-Label Use Rx. 01.33
| | NA | NA | | 471 | | | 10/1/2024 | Rx.01.182 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Irritable bowel syndrome (IBS), a common, functional gastrointestinal disorder, is defined as abdominal discomfort associated with altered bowel habits. Three subtypes of IBS exist: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed type (IBS-M). Diagnosis of IBS is based solely on clinical criteria as there are no radiologic or endoscopic abnormalities in IBS and no biomarker has proven reliable for diagnosis. Approximately 10-15% of the general adult population is affected by IBS. Hepatic encephalopathy (HE) is defined as brain dysfunction caused by liver insufficiency and/or portosystemic shunting. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. Small Bowel Bacterial Overgrowth (SBBO)/Small Intestinal Bacterial Overgrowth (SIBO) is a condition in which the small bowel is colonized by excessive aerobic and anaerobic microbes. Therapy is typically begun after confirming SBBO/SIBO by breath test. Patients with SBBO/SIBO could present with bloating, flatulence, abdominal discomfort, or chronic watery diarrhea. Rifaximin (Xifaxan®), a semisynthetic antibiotic, is derived from rifampin. It inhibits bacterial protein synthesis and growth by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase, blocking one of the steps in transcription. Rifaximin is indicated for reduction in risk of overt HE recurrence in adults, treatment of IBS-D in adults, and Small Bowel Bacterial Overgrowth (SBBO)/Small Intestinal Bacterial Overgrowth (SIBO). When treating IBS-D, the course of therapy is 14 days. The regimen may be repeated up to 2 times.
| The intent of this policy is to communicate the medical necessity criteria for rifaximin (Xifaxan®) as provided under the member’s prescription drug benefit.
| Hepatic disease with risk of hepatic encephalopathy INITIAL CRITERIA: Rifaximin (Xifaxan®) 550 mg is approved when BOTH of the following are met: - Diagnosis of hepatic disease with risk for hepatic encephalopathy (i.e., previous episode of hepatic encephalopathy, advanced liver disease, hepatocellular carcinoma); and
- Member is 18 years of age or older; and
- Inadequate response or inability to tolerate lactulose
Initial authorization duration: 2 years (Maximum daily dose 2/day)
REAUTHORIZATION CRITERIA Rifaximin (Xifaxan®) 550mg is re-approved when there is documentation of positive clinical response to therapy. Reauthorization duration: 2 years (Maximum daily dose 2/day) ________________________________________________________________________________________
Irritable Bowel Syndrome with Diarrhea INITIAL CRITERIA: Rifaximin (Xifaxan®) 550mg is approved when All of the following are met: - Diagnosis of irritable bowel syndrome- diarrhea; and
- Inadequate response or inability to tolerate an antispasmodic; and
- Member is 18 years of age or older; and
- Member does not exceed 3 courses (42 days) of therapy
Initial authorization duration: 3 months (max of 14 days/84 days; Maximum daily dose 3/day)
REAUTHORIZATION CRITERIA: Rifaximin (Xifaxan®) 550mg is re-approved when ALL of the following are met:
- Diagnosis of irritable bowel syndrome – diarrhea; and
- Symptoms of Irritable Bowel Syndrome continue to persist; and
- Member demonstrates positive clinical response to therapy as evidenced by both of the following:
- Improvement in abdominal pain; and
- Reduction in the Bristol Stool Scale; and
- Inadequate response or inability to tolerate an antispasmodic; and
- BOTH of the following:
- Member does not exceed 3 courses (42 days) of therapy; and
- No documentation of rifaximin (Xifaxan®) treatment within the last 10 weeks.
Reauthorization duration: 3 months (max of 14 days/84 days; Maximum daily dose 3/day) ___________________________________________________________________________________________ Small Bowel Bacterial Overgrowth (SBBO)/Small Intestinal Bacterial Overgrowth (SIBO) INITIAL CRITERIA: Rifaximin (Xifaxan®) 550mg is approved when ALL of the following are met: - Diagnosis of Small Bowel Overgrowth (SBBO)/Small Intestinal Bacterial Overgrowth (SIBO); and
- Inadequate response or inability to tolerate two of the following antibiotics:
- Neomycin; or
- Amoxicillin/clavulanic acid (Augmentin); or
- Ciprofloxacin (Cipro); or
- Trimethoprim-sulfamethoxazole (Bactrim); or
- Doxycycline (Vibramycin) or minocycline (Minocin) or tetracycline; or
- Metronidazole (Flagyl); or
- Cephalexin (Keflex)
Initial authorization duration: 3 months (Maximum daily dose 3/day) REAUTHORIZATION CRITERIA: Rifaximin (Xifaxan®) 550mg is re-approved when all of the following are met: - Diagnosis of Small Bowel Overgrowth (SBBO)/Small Intestinal Bacterial Overgrowth (SIBO); and
- Member demonstrates positive clinical response to therapy (e.g., resolution of symptoms); and
- Member experiences relapse with Xifaxan discontinuation
Reauthorization duration: 3 months (Maximum daily dose 3/day)
| | | American Association for the Study of Liver Diseases and European Association for the Study of the Liver. Hepatic Encephalopathy in Chronic Liver Disease: 2014 Practice Guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. Journal of Hepatology. Available from: http://www.easl.eu/medias/cpg/Hepatic-Encephalopathy-Chronic-Liver-Disease/English-report.pdf. Accessed August 4, 2024. Ford AC, Moayyedi P, Lacy, BE, et al. American College of Gastroenterology Monograph on the Management of Irritable Bowel Syndrome and Chronic Idiopathic Constipation. Am J Gastroenterol. 2014: 109:S2-S26; doi: 1001038/ajg.2014.187 Weinberg DS, Smalley W, Heidelbaugh JJ, et al. American Gastroenterological Association Institute Guideline on the Pharmacological Management of Irritable Bowel Syndrome. Gastroenterology. 2014; 147(5):1146-48. Xifaxan® (rifaximin) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals; September 2022. Available from: https://shared.salix.com/shared/pi/xifaxan550-pi.pdf. Accessed August 4, 2024. Pimentel M. Small intestinal bacterial overgrowth: Clinical manifestations and diagnosis. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA, February 2022. Accessed August 4, 2024. | 13 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:18 AM | srv_ppsgw_P | | Brand Name
| Generic Name
| Xifaxan®
| Rifaximin
|
| NA | NA | | 472 | | | 10/1/2024 | Rx.01.215 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Hereditary transthyretin amyloidosis (hATTR) is a rare autosomal dominant, progressively debilitating, and often fatal genetic disease characterized by the accumulation of abnormal amyloid protein in tissues. Transthyretin (TTR) is produced primarily by the liver and is responsible for the transport of thyroxine and retinol binding protein-vitamin A complex. The hATTR genetic mutations lead to mutated TTR protein which results in destabilization from the TTR tetramer into monomers and oligomers, protein misfolding, and aggregation resulting in formation of TTR amyloid fibrils. hATTR can present with peripheral and/or autonomic neuropathy, infiltrative cardiomyopathy, vitreous amyloid, or leptomenigeal disease. Inotersen (Tegsedi™) is an antisense oligonucleotide that causes degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues. Inotersen (Tegsedi™) is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) occurs when amyloidosis occurs in the cardiac tissue. Wild type ATTR-CM typically presents in men aged 65 years and older, but it can occur in women and in younger patients. Amyloid accumulates in the cardiac tissue leading to atrial and ventricular wall thickening and diastolic dysfunction, arrhythmias, and preserved ejection fraction heart failure. For wild type ATTR-CM, the median survival is reported to be 3.6 years. Patients with wild type ATTR may also present with bilateral carpal tunnel syndrome as an initial symptom years before the onset of cardiac symptoms (Sekijima 2015). Due to the lack of effective therapy, testing for ATTR-CM has been underutilized. Testing may include echocardiogram, cardiac magnetic resonance imaging (MRI), and nuclear scintigraphy. Tissue biopsy, either endomyocardial tissue or other locations such as abdominal fat pad, is the gold standard for diagnosis of amyloidosis. A non-invasive test to identify those with ATTR-CM is radiotracer 99mtechnetium pyrophosphate scan (99mTc-PYP). The FDA-has not yet approved 99mTc-PYP test for the diagnosis of ATTR-CM, but it is being used in clinical practice (Vyndaqel Dossier 2019). Tafamidis meglumine (Vyndaqel®, Vyndamax ®) is a selective transthyretin (TTR) stabilizer, limiting the dissociation of the native TTR tetramer into monomers, which reduces TTR amyloid fibril formation. Tafamidis meglumine (Vyndaqel®, Vyndamax ®) is indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Eplontersen is an antisense oligonucleotide-GalNAc conjugate that causes degradation of
mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a
reduction of serum TTR protein and TTR protein deposits in tissues.
WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment
of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
| The intent of this policy is to communicate the medical necessity criteria for inotersen (Tegsedi) ), tafamidis meglumine (Vyndamax®, Vyndaqel®), eplontersen (Wainua) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Tegsedi™ (inotersen) is approved when ALL of the following are met: - Diagnosis of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis with transthyretin mutation (e.g., V30M) confirmed by molecular genetic testing; and
- Documentation of ONE of the following baseline ambulation parameters in either the Familial Amyloid Polyneuropathy (FAP) Stage or Polyneuropathy Disability (PND) Score
- Stage 1 (unimpaired ambulation) or 2 (assisted ambulation) on the Familial Amyloid Polyneuropathy (FAP) staging tool; or
- Score I, II, IIIa, or IIIb on the Polyneuropathy Disability (PND) scoring tool; AND
- Documented presence of cardiac or renal manifestations, or motor, sensory, or autonomic neuropathy related to the hATTR amyloidosis with polyneuropathy (e.g., neuropathic pain, muscle weakness that affects daily living, orthostatic hypotension, diarrhea, nausea, vomiting, heart failure, arrhythmias, proteinuria, renal failure; vision disorders, such as vitreous opacity, dry eyes, glaucoma, or pupils with an irregular or scalloped appearance; and
- Documentation confirming the member has not had a liver transplant; and
- Prescribed by or in consultation with a neurologist, geneticist, or professional provider specializing in the treatment of amyloidosis; and
- Member is 18 years of age or older; and
- No concurrent use with another TTR silencer (e.g., patisiran (Onpattro), vutrisiran (Amvuttra), eplontersen (Wainua)) or with a TTR stabilizer (e.g., Vyndaqel, Vyndamax)
Initial authorization duration: 16 months
CONTINUATION CRITERIA Tegsedi™ (inotersen) is re-approved when BOTH of the following are met:
- Documentation of one of the following
- Stage 1 (unimpaired ambulation) or 2 (assisted ambulation) on the Familial Amyloid Polyneuropathy (FAP) staging tool; or
- Score I, II, IIIa, or IIIb on the Polyneuropathy Disability (PND) scoring tool; and
- Documented improvement or stability in the signs and symptoms hATTR amyloidosis with polyneuropathy (e.g., neuropathic pain, muscle weakness that affects daily living, orthostatic hypotension, diarrhea, nausea, vomiting, heart failure, arrhythmias, proteinuria, renal failure; vision disorders, such as vitreous opacity, dry eyes, glaucoma, or pupils with an irregular or scalloped appearance), based on objective or standard evaluation scales; and
- No concurrent use with another TTR silencer (e.g., patisiran (Onpattro), vutrisiran (Amvuttra), eplontersen (Wainua)) or with a TTR stabilizer (e.g., Vyndaqel, Vyndamax)
Continuation authorization duration: 2 years INITIAL CRITERIA Tafamidis meglumine (Vyndamax®, Vyndaqel®) is approved when ALL of the following are met: - Member is 18 years of age or older; and
- Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) confirmed by ONE of the following:
- Member has a transthyretin (TTR) mutation (e.g., V122I), or
- Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits, or
- All of the following: echocardiogram or cardiac magnetic resonance image suggestive of amyloidosis, scintigraphy scan suggestive of cardiac TTR amyloidosis, and absence of light-chain amyloidosis; and
- Prescribed by or in consultation with a cardiologist; and
- One of the following:
- History of heart failure (HF), with at least one prior hospitalization for HF, or
- Presence of clinical signs and symptoms of HF (e.g., dyspnea, edema); or
- Member has New York Heart Association (NYHA) Functional Class I, II, or III heart failure; and
- No concurrent use with a TTR silencer (e.g., patisiran (Onpattro), vutrisiran (Amvuttra), eplontersen (Wainua), inotersen (Tegsedi))
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Tafamidis meglumine (Vyndamax®, Vyndaqel®) is re-approved when ALL of the following are met: - Positive clinical response to therapy; and
- Member continues to have NYHA Functional Class I, II, or III heart failure; and
- Prescribed by or in consultation with a cardiologist; and
- No concurrent use with a TTR silencer (e.g., patisiran (Onpattro), vutrisiran (Amvuttra), eplontersen (Wainua), inotersen (Tegsedi))
Reauthorization duration: 12 months
INITIAL CRITERIA: Eplontersen (Wainua™) is approved when ALL of the following are met: - Diagnosis of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with polyneuropathy; and
- Member is 18 years of age or older; and
- Member has a transthyretin (TTR) mutation (e.g., V30M); and
- One of the following:
- Member has a baseline familial amyloidotic polyneuropathy (FAP) stage of 1 or 2; or
- Member has a baseline neuropathy impairment score (NIS) greater than or equal to 10 and less than or equal to 130; or
- Member has a baseline Karnofsky Performance Status score greater than 50%; and
- Presence of clinical signs and symptoms of the disease (e.g., neuropathy); and
- Member has not had a liver transplant; and
- Prescribed by or in consultation with a neurologist; and
- No concurrent use with another TTR silencer (e.g., patisiran (Onpattro), vutrisiran (Amvuttra), inotersen (Tegsedi)) or with a TTR stabilizer (e.g., Vyndaqel, Vyndamax)
Initial authorization duration: 12 months CONTINUATION CRITERIA: Eplontersen (Wainua™) is re-approved when ALL of the following are met: - Member demonstrates positive clinical response to therapy as evidenced by an improvement in clinical signs and symptoms from baseline (e.g., neuropathy, quality of life, lower serum TTR level); and
- One of the following:
- Member continues to have a familial amyloidotic polyneuropathy (FAP) stage of 1 or 2; or
- Member continues to have a neuropathy impairment score (NIS) greater than or equal to 10 and less than or equal to 130; or
- Member continues to have a Karnofsky Performance Status score greater than 50%; and
- Member has not had a liver transplant; and
- Prescribed by or in consultation with a neurologist; and
- No concurrent use with another TTR silencer (e.g., patisiran (Onpattro), vutrisiran (Amvuttra), inotersen (Tegsedi)) or with a TTR stabilizer (e.g., Vyndaqel, Vyndamax)
Continuation approval duration: 12 months
| WARNING: THROMBOCYTOPENIA AND GLOMERULONEPHRITIS Thrombocytopenia - TEGSEDI causes reductions in platelet count that may result in sudden and unpredictable thrombocytopenia, which can be life-threatening.
- Testing prior to treatment and monitoring during treatment is required
Glomerulonephritis- TEGSEDI can cause glomerulonephritis that may require immunosuppressive treatment and may result in dialysis-dependent renal failure.
- Testing prior to treatment and monitoring during treatment is required
| | Gorevic PD. Genetic factors in the amyloid diseases. UpToDate Web site. Updated December 18, 2018. Available from: http://www.uptodate.com/. Accessed August 4, 2024. Grogan M, Scott CG, Kyle RA, et al. Natural history of wild type transthyretin cardiac amyloidosis and risk stratification using a novel staging system. J Am Coll Cardiol. 2016;68:1014-1020. Hawkins PN, Ando Y, Dispenzeri A, et al. Evolving landscape in the management of transthyretin amyloidosis. Ann Med. 2015;47:625-638. Klaassen SHC, Tromp J, Nienhuis HLA, et al. Involvement at presentation in hereditary transthyretin-derived amyloidosis and the value of N-terminal pro-B-type natriuretic peptide. Am J Cardiol. 2018;121:107-112. Maurer MS, Grogan DR, Judge DP, et al. Tafamidis in transthyretin amyloid cardiomyopathy. Effects on transthyretin stabilization and clinical outcomes. Circ Heart Fail. 2015;8:519-526. Maurer MS, Hanna M, Grogan M, et al. Genotype and phenotype of transthyretin cardiac amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016;68(2):161-172. Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379:1007-1016. Fontana M. Cardiac amyloidosis: Epidemiology, clinical manifestations, and diagnosis. UpToDate Web site. Updated August 2022. Available from: https://www.uptodate.com/contents/cardiac-amyloidosis-clinical-manifestations-and-diagnosis?search=clinical-manifestations-and-diagnosis-of-amyloid-cardiomyopathy&source=search_result&selectedTitle=1~80&usage_type=default&display_rank=1. Accessed August 4, 2024. Merlini G, Planté-Bordeneuve V, Judge DP, et al. Effects of tafamidis on transthyretin stabilization and clinical outcomes in patients with non-Val30Met transthyretin amyloidosis. J Cardiovasc Trans Res. 2013;6:1011-1020. Mundayat R, Steward M, Alvir J, et al. Positive effectiveness of tafamidis in delaying disease progression in transthyretin familial amyloid polyneuropathy up to 2 years: an analysis from the Transthyretin Amyloidosis Outcomes Survey (THAOS) Neurol Ther. 2018;7:87-101. Nativi-Nicolau J, Maurer MS. Amyloidosis cardiomyopathy: update in diagnosis and treatment of the most common types. Curr Opin Cardiol. 2018;33(5):571-579. Pfizer Press Release. FDA issues complete response letter for Pfizer's tafamidis meglumine new drug application. https://investors.pfizer.com/investor-news/press-release-details/2012/FDA-Issues-Complete-Response-Letter-For-Pfizers-Tafamidis-Meglumine-New-Drug-Application/default.aspx. June 18, 2012. Accessed August 4, 2024. Plante-Bordeneuve V. Update in the diagnosis and management of transthyretin familial amyloid polyneuropathy. J Neurol. 2014;261:1227-1233. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016;37(27):2129-2200. Seferović PM, Polovina M, Bauersachs J, et al. Heart failure in cardiomyopathies: a position paper from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019;21:553-576. Sekijima Y. Transthyretin (ATTR) amyloidosis: clinical spectrum, molecular pathogenesis and disease-modifying treatments. J Neurol Neurosurg Psychiatry. 2015;86:1036-1043. Siddiqi OK, Ruberg FL. Cardiac amyloidosis: an update on pathophysiology, diagnosis, and treatment. Trends Cardiovasc Med. 2018;28:10-21. Tegsedi™ (inotersen) [prescribing information]. Boston MA. Akcea Therapeutics, Inc. June 2022. Available at: https://tegsedi.com/wp-content/uploads/2018/10/prescribing-information.pdf. Accessed August 4, 2024. Vyndaqel and Vyndamax (tafamidis, tafamidis meglumine )[prescribing information]. New York, NY: Pfizer Pharmaceuticals, Inc. April 2023. Available from: labeling.pfizer.com/ShowLabeling.aspx?id=11685. Accessed August 4, 2024. Wainua (eplontersen) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. December 2023. Available at: WAINUA Full Prescribing Information (den8dhaj6zs0e.cloudfront.net). Accessed August 4, 2024.
| 8 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:18 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Tegsedi™ | Inotersen | | Vyndamax®, Vyndaqel® | Tafamidis meglumine | | Wainua™ | eplontersen |
| N/A | N/A | | 474 | | | 10/1/2024 | Rx.01.45 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Intranasal steroids are used for a variety of disorders including nasal polyps, non-allergic rhinitis, perennial allergic rhinitis and seasonal allergic rhinitis.
Intranasal steroids provide anti-inflammatory effects on the nasal mucosa. Their exact mechanism is unknown but corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.
| The intent of this policy is to communicate the medical necessity criteria for beclomethasone (Beconase AQ®), fluticasone propionate (Xhance™), beclomethasone (Qnasl®/ Qnasl®Children's), azelastine hydrochloride and fluticasone propionate (Dymista®), and olopatadine hydrochloride and mometasone furoate (Ryaltris®) as provided under the member's prescription drug benefit.
| Nasal polyps INITIAL CRITERIA: Beconase AQ®, or fluticasone propionate (Xhance™) is approved when BOTH of the following are met: - Diagnosis of nasal polyps; and
- Submission of documentation (e.g., chart note) or paid claim history showing inadequate response or inability to tolerate generic fluticasone propionate (trial for at least 90 days within the previous 365 days)
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Beconase AQ®, or fluticasone propionate (Xhance®) is reapproved when there is documentation of positive clinical response to therapy. Reauthorization duration: 2 years Allergic Rhinitis
INITIAL CRITERIA: Beconase AQ®, Children's Qnasl®*, azelastine hydrochloride and fluticasone propionate (Dymista), Qnasl®, or Ryaltris® is approved when BOTH of the following are met: - Diagnosis of allergic rhinitis; and
- Inadequate response or inability to tolerate BOTH of the following generic nasal sprays:
- Flunisolide; and
- Fluticasone propionate
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA: Beconase AQ®, Children's Qnasl®*, azelastine hydrochloride and fluticasone propionate (Dymista®), Qnasl®, or Ryaltris® is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years *Fluticasone propionate is approved for children under 6 years of age
Chronic rhinosinusitis without nasal polyps INITIAL CRITERIA: Fluticasone propionate (Xhance™) is approved when BOTH of the following are met: - Diagnosis of chronic rhinosinusitis without nasal polyps; and
- Submission of documentation (e.g., chart notes) or paid claim history showing inadequate response or inability to tolerate generic fluticasone propionate (trial of at least 90 days within the previous 365 days)
Initial authorization duration: 2 yearsREAUTHORIZATION CRITERIA: Fluticasone propionate (Xhance™) is re-approved with documentation of positive clinical response to therapy Reauthorization duration: 2 years
| | | Beconase AQ (beclomethasone dipropionate) [package insert]. Research Triangle Park, NC. GlaxoSmithKline. April 2019. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Beconase_AQ/pdf/BECONASE-PI-PIL.PDF Accessed August 4, 2024. Dymista (azelastine hydrochloride and fluticasone propionate) [package insert]. Somerset, NJ. Meda Pharmaceutical. September 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202236s008lbl.pdf. Accessed August 4, 2024. Qnasl® (beclomethasone) [package insert]. Northridge, CA. Teva Respiratory, LLC. March 2018. Available at: http://qnasl.com/Content/pdf/pi.pdf Accessed August 4, 2024. Ryaltris® (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray) [package insert]. Columbus, OH: Hikma Specialty USA Inc. January 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=382eac74-a7ce-4f42-ac0a-b253308f335f. Accessed August 4, 2024. Seidman MD et al. Clinical practice guideline: allergic rhinitis executive summary. Otolaryngol Head Neck Surg. 2015 Feb; 152(2): 197-206. Wallace DV et al. Pharmacologic treatment of seasonal allergic rhinitis: synopsis of guidance from the 2017 Joint Task Force on practice parameters. Ann Intern med. 2017 Dec 19; 167(12):867-881 Peters AT et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014 Oct; 113(4): 347-85.
Xhance (fluticasone propionate) [prescribing information]. Yardley, PA: OptiNose US. Inc. March 2024. Availabel at: Approval [Rx ONLY] (xhance.com). Accessed August 4, 2024.
.
| 26 | 7/1/2024 | 3/14/2025 | 10/1/2024 1:18 AM | srv_ppsgw_P | | | Beconase AQ® | beclomethasone | | Dymista® | azelactine hydrochloride and fluticasone propionate | | Qnasl® | beclomethasone dipropionate | | Qnasl®Childrens | beclomethasone dipropionate | | Xhance™ | Fluticasone propionate | | Ryaltris® | olopatadine hydrochloride and mometasone furoate monohydrate |
| Xhance® | fluticasone propionate | | 477 | | | 10/1/2024 | Rx.01.293 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Eosinophilic esophagitis (EoE) is a chronic allergic/immune condition of the esophagus. In EoE, large number of eosinophils are found in the inner lining of the esophagus resulting in inflammation which causes symptoms such as chest pain ,heartburn, difficulty swallowing, or impaction. roton pump inhibitors (PPIs) are among first line treatment options, together with dietary modification and topical glucocorticoids. Clinical manisfestations in adults include: dysphagia, food impaction, chest pain that is often centrally located and may not respond to antacids, gastroesophageal reflux disease-like symptoms/refractory heartburn, and upper abdominal pain.
Budesonide is an anti-inflammatory corticosteroid and has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.
The precise mechanism of corticosteroid actions on inflammation in EoE is not known. Inflammation is an important component in the pathogenesis of EoE. Corticosteroids have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukocytes and cytokines) involved in allergic inflammation.
Eohilia™ is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). | The intent of this policy is to communicate the medical necessity criteria for Budesonide (Eohilia™) as provided under the member's prescription drug benefit.
| Budesonide (Eohilia™) is approved when ALL of the following are met: - Diagnosis of eosinophilic esophagitis (EoE); and
- Member has symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, heartburn, abdominal pain); and
- Member has at least 15 intraepithelial eosinophils per high power field (HPF); and
- Other causes of esophageal eosinophilia have been ruled out; and
- Member is 11 years of age or older; and
- Inadequate response or inability to tolerate a minimum 8-week duration of both of the following:
- Proton pump inhibitor (e.g., pantoprazole, omeprazole); and
- Topical (esophageal) corticosteroid (e.g., budesonide, fluticasone); and
- Prescribed by or in consultation with one of the following:
- Allergist/immunologist; or
- Gastroenterologist
Authorization duration: 12 weeks
| | | Bonis PA, Gupta SK. Clinical manifestations and diagnosis of eosinophilic esophagitis (EoE). In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed July 31, 2024.
Bonis PA, Gupta SK. Treatment of eosinophilic esophagitis (EoE). In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed July 31, 2024.
Eohilia™ (budesonide oral suspension) [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc. February 2024. Available at: https://content.takeda.com/?contenttype=PI&product=EOH&language=ENG&country=USA&documentnumber=1. Accessed July 31, 2024. | 1 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:19 AM | srv_ppsgw_P | Off-Label Use Rx.01.33
Quantity level limits for pharmaceuticals covered under the prescription drug benefit Rx.01.76
| | Brand Name | Generic Name | | Eohilia™ | Budesonide oral suspension |
| Eohilia™ | budesonide | | 478 | | | 10/1/2024 | Rx.01.294 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Epidermolysis bullosa (EB) is a group of hereditary rare diseases that cause the skin to be fragile and to blister easily. There are four major types of EB, based upon the ultrastructural level of tissue cleavage in the skin: epidermolysis bullosa simplex (EBS), junctional epidermolysis bullosa (JEB), dystrophic epidermolysis bullosa (DEB), and Kindler epidermolysis bullosa (KEB). There is no cure for EB. The management of patients with EB is largely supportive and includes wound care and prevention and treatment of complications.
The mechanism of action of FILSUVEZ in the treatment of wounds associated with epidermolysis bullosa is unknown. Filsuvez® is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. | The intent of this policy is to communicate the medical necessity criteria for Birch triterpenes (Filsuvez®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Birch triterpenes (Filsuvez®) is approved when ALL of the following are met: - Diagnosis of one of the following:
- Dystrophic epidermolysis bullosa (DEB); or
- Junctional epidermolysis bullosa (JEB); and
- Disease is confirmed by one of the following:
- Genetic testing confirms mutation in one of the following genes:
- For Dystrophic epidermolysis bullosa (DEB), collagen type VII (COL7A1); or
- For Junctional epidermolysis bullosa (JEB), one of the following:
- ITGA6; or
- ITGB4; or
- Collagen type XVII (COL17A1); or
- LAMA3; or
- LAMB3; or
- LAMC2; or
- ITGA3; or
- LAMA3A; or
- Skin biopsy; and
- Member is 6 months of age or older; and
- Medication will be used for the treatment of wounds; and
- DEB or JEB associated wounds are present for at least 21 days and less than 9 months; and
- Member does not have signs of infection for wound being treated; and
- Member has no evidence or history of basal or squamous cell carcinoma for wound being treated; and
- Member does not have history of stem cell transplant or gene therapy (e.g., Vyjuvek) for the treatment of epidermolysis bullosa; and
- Standard wound care management not adequate in healing wounds (e.g., daily wound dressings, pain management, controlling infections); and
- Prescribed by or in consultation with a dermatologist with expertise in the treatment of epidermolysis bullosa
Initial authorization duration: 3 months REAUTHORIZATION CRITERIA: Birch triterpenes (Filsuvez®) is re-approved when ALL of the following are met: - Member demonstrates positive clinical response to therapy as evidenced by wound is healing but not completely closed; and
- Member does not have signs of infection for wound being treated; and
- Member has no evidence or history of basal or squamous cell carcinoma for wound being treated; and
- Prescribed by or in consultation with a dermatologist with expertise in the treatment of epidermolysis bullosa
Reauthorization duration: 6 months
| | | National Institute of Arthritis and Musculoskeletal and Skin Diseases. Epidermolysis Bullosa. U.S. Department of Health and Human Services, National Institutes of Health. September 2023. Available at: https://www.niams.nih.gov/health-topics/epidermolysis-bullosa. Accessed July 31, 2024.
Murrell DF. Overview of the management of epidermolysis bullosa. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed July 31, 2024.
Filsuvez® (Birch triterpenes) [package insert]. Wahlstedt, Germany: Lichtenheldt GmbH Pharmazeutische Fabrik. May 2024. Available at: https://resources.chiesiusa.com/Filsuvez/FILSUVEZ_PI.pdf. Accessed July 31, 2024.
| 1 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:19 AM | srv_ppsgw_P | Off-Label Use Rx.01.33
Quantity level limits for pharmaceuticals covered under the prescription drug benefit Rx.01.76
| | Brand Name | Generic Name | | Filsuvez® | Birch triterpenes |
| Filsuvez® | birch triterpenes | | 481 | | | 10/1/2024 | Rx.01.296 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Myasthenia gravis (MG) is an autoimmune neuromuscular disorder characterized by fluctuating motor weakness. The weakness is due to an antibody-mediated, immunologic attack directed at proteins in the postsynaptic membrane of the neuromuscular junction (acetylcholine receptors or receptor-associated proteins). MG is the most common disorder of neuromuscular transmission. MG symptoms can include: weakness of the eye muscles, blurred or double vision, changes in facial expressions, difficulty swallowing, extremely weak arms/hands/legs, profound tiredness, and impaired speech.
Zilucoplan binds to the complement protein C5 and inhibits its cleavage to C5a and C5b, preventing the generation of the terminal complement complex, C5b-9. The precise mechanism by which zilucoplan exerts its therapeutic effect in generalized myasthenia gravis is unknown but is presumed to involve reduction of C5b-9 deposition at the neuromuscular junction. Zilucoplan (Zilbrysq®) is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. | The intent of this policy is to communicate the medical necessity criteria for Zilucoplan (Zilbrysq®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Zilucoplan (Zilbrysq®) is approved when ALL of the following are met: - Diagnosis of generalized myasthenia gravis (gMG); and
- Member is 18 years of age or older; and
- Member is anti-acetylcholine receptor (AChR) antibody positive; and
- One of the following:
- Inadequate response or inability to tolerate two immunosuppressive therapies (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus); or
- Both of the following:
- Inadequate response or inability to tolerate one immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus); and
- Inadequate response or inability to tolerate one of the following:
- Chronic plasmapheresis or plasma exchange (PE); or
- Intravenous Immunoglobulin (IVIG); and
- Prescribed by or in consultation with a neurologist; and
- No concurrent use with rozanolixizumab-noli (Rystiggo), eculizumab (Soliris), ravulizumab-cwvz (Ultomiris) or efgartigimod alfa-fcab (Vyvgart, Vyvgart Hytrulo)
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Zilucoplan (Zilbrysq®) is re-approved when ALL of the following are met: - Documentation of positive clinical response to therapy; and
- Prescribed by or in consultation with a neurologist; and
- No concurrent use with rozanolixizumab-noli (Rystiggo), eculizumab (Soliris), ravulizumab-cwvz (Ultomiris) or efgartigimod alfa-fcab (Vyvgart, Vyvgart Hytrulo)
Reauthorization duration: 12 months
| WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors; ZILBRYSQ is a complement inhibitor. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.
- Complete or update meningococcal vaccination at least 2 weeks prior to administering the first dose of ZILBRYSQ, unless the risk of delaying therapy outweighs the risk of developing a meningococcal infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor.
- Persons receiving ZILBRYSQ are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
ZILBRYSQ is available only through a restricted program called ZILBRYSQ REMS.
| | National Institute of Neurological Disorders and Stroke. Myasthenia Gravis. U.S. Department of Health and Human Services, National Institutes of Health. July 2024. Available at: https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravis. Accessed July 31, 2024.
Bird SJ. Overview of the treatment of myasthenia gravis. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed July 31, 2024.
Bird SJ. Chronic immunotherapy for myasthenia gravis. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed July 31, 2024.
Zilbrysq® (zilucoplan) [package insert]. Smyrna, GA; UCB Inc. April 2024. Available at: https://www.ucb-usa.com/zilbrysq-prescribing-information.pdf. Accessed July 31, 2024.
| 1 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:20 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Zilbrysq® | Zilucoplan |
| Zilbrysq® | zilucoplan | | 482 | | | 10/1/2024 | Rx.01.295 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Primary hyperoxalurias (PHs) are rare inborn errors of glyoxylate metabolism characterized by the overproduction of oxalate, which is poorly soluble and is deposited as calcium oxalate in various organs. PH is primarily caused by autosomal recessive variants in three genes that encode enzymes involved in glyoxylate metabolism. In patients with PH, the increased production results in increased urinary excretion of oxalate leading to kidney injury and, in some cases, end-stage kidney failure. There are 3 types of PH: PH1, PH2, and PH3. PH1 is the most commonly clinically diagnosed type of PH.
Nedosiran is a double-stranded siRNA, conjugated to GalNAc aminosugar residues. After subcutaneous administration, the GalNAc-conjugated sugars bind to asialoglycoprotein receptors (ASGPR) to deliver nedosiran to hepatocytes. Nedosiran reduces levels of hepatic lactate dehydrogenase (LDH) via the degradation of LDHA messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. The reduction of hepatic LDH by nedosiran reduces the production of oxalate by the liver, thereby reducing subsequent oxalate burden. Rivfloza™ is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m2.
| The intent of this policy is to communicate the medical necessity criteria for Nedosiran (Rivfloza™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Nedosiran (Rivfloza™) is approved when ALL of the following are met: - Diagnosis of primary hyperoxaluria type 1 (PH1); and
- Disease has been confirmed by both of the following:
- One of the following:
- Elevated urinary oxalate excretion; or
- Elevated plasma oxalate concentration; or
- Spot urinary oxalate to creatinine molar ratio greater than normal for age; and
- One of the following:
- Genetic testing demonstrating a mutation in the alanine: glyoxylate aminotransferase (AGXT) gene; or
- Liver biopsy demonstrating absence or reduced alanine: glyoxylate aminotransferase (AGT) activity; and
- Member is 9 years of age or older; and
- Member has preserved kidney function (e.g., eGFR greater than or equal to 30 ml/min/1.72m2); and
- Member has not received a liver transplant; and
- Prescribed by or in consultation with one of the following:
- Hepatologist
- Nephrologist
- Urologist
- Geneticist
- Specialist with expertise in the treatment of PH1
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Nedosiran (Rivfloza™) is re-approved when ALL of the following are met: - Member demonstrates positive clinical response to therapy (e.g., decreased urinary oxalate excretion, decreased plasma oxalate concentration); and
- Member has not received a liver transplant; and
- Prescribed by or in consultation with one of the following:
- Hepatologist
- Nephrologist
- Urologist
- Geneticist
- Specialist with expertise in the treatment of PH1
Reauthorization duration: 12 months
| | | Niaudet P. Primary hyperoxaluria. In: UpToDate, Connor RF (Ed), Wolters Kluwer. January 2024. Accessed July 31, 2024.
Rivfloza™ (Nedosiran) [package insert]. Plainsboro, NJ: Novo Nordisk Inc. September 2023. Available at: https://www.novo-pi.com/rivfloza.pdf. Accessed July 31, 2024. | 1 | 7/1/2024 | 6/6/2025 | 10/1/2024 1:20 AM | srv_ppsgw_P | Rx.01.33 Off Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Rivfloza™ | Nedosiran |
| Rivfloza™ | nedosiran | | 484 | | | 1/1/2025 | Rx.01.292 | Commercial | Oyenusi, Oluwadamilola | Q2-2024 | Demodex blepharitis is a common eyelid condition caused by the infestation of the eyelashes, lash follicles, or meibomian glands by the mites Demodex folliculorum or Demodex brevis. The condition is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes, which are cylindrical, waxy debris of mite waste products and eggs at the base of eyelashes. Xdemvy is the only FDA-approved treatment for Demodex blepharitis. The Preferred Practice Pattern for blepharitis from the American Academy of Opththalmology indicates that weekly 50% tea tree oil eyelid scrubs and daily tea tree oil shampoo scrubs used for a minimum of 6 weeks may be beneficial.
Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites. Inhibition of these GABA chloride channels causes a paralytic action in the target organism leading to its death.
Xdemvy is indicated for the treatment of Demodex blepharitis.
| | The intent of this policy is to communicate the medical necessity criteria for lotilaner (Xdemvy) as provided under the member's prescription drug benefit. |
| Lotilaner (Xdemvy®) is approved when ALL of the following are met: - Diagnosis of Demodex blepharitis; and
- Member exhibits one of the following signs of Demodex infestation:
- Collarettes; or
- Eyelid margin erythema; or
- Eyelash anomalies (e.g., eyelash misdirection); and
- Member is experiencing symptoms of architectural changes associated with Demodex infestation (e.g., burning, tearing, itching, foreign body sensation, eyelashes missing, eyelashes growing inward); and
- Inadequate response or inability to tolerate tea tree-oil; and
- Prescribed by or in consultation with one of the following:
- Ophthalmologist; or
- Optometrist
Authorization duration: 2 months
| | | | 1 | 7/1/2024 | 6/6/2025 | 1/1/2025 1:11 AM | srv_ppsgw_P | Rx.01.33 Off-Label Use policy. Rx.01.76 Quantity Level Limits For Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand | Generic | | Xdemvy® | Lotilaner |
| Xdemvy® | Lotilaner | | 485 | | | 1/1/2025 | Rx.01.87 | Commercial | VanHorn, Lynnsey | Q3-2024 | Parathyroid hormone (PTH) and calcitriol are the two major hormones that regulate calcium and phosphate homeostasis. PTH maintains serum ionized calcium concentrations in a narrow range by stimulating renal tubular calcium reabsorption and bone resorption. Chronic exposure to high PTH results in bone resorption, however intermittent administration of recombinant human PTH stimulates bone formation to a greater extent than resorption, at least over the first 12 months of therapy. While PTH is an effective treatment for osteoporosis, it is generally not a first line drug due to route of administration (subcutaneous), long-term safety concerns, and availability of other agents. Teriparatide is recombinant human PTH. Abaloparatide is a human parathyroid hormone related peptide (PTHrP(1-34)). Teriparatide (Forteo®) is indicated:
- For the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. These include women with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment.
- To increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment.
- For treatment of osteoporosis associated with sustained systemic glucocorticoid therapy at high risk fracture.
Abaloparatide (Tymlos™) is indicated: - For the treatment of postmenopausal women with osteoporosis at high risk of fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
- For the treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
| The intent of this policy is to communicate the medical necessity criteria for abaloparatide (Tymlos™) and teriparatide (Forteo®) as provided under the member's prescription drug benefit.
| Primary or hypogonadal osteoporosis in men and Glucocorticoid-induced osteoporosis in men or women INITIAL CRITERIA: Teriparatide (Forteo®) is medically necessary when ALL of the following are met: - The member is 18 years of age or older; and
- ONE of the following:
- Primary or hypogonadal osteoporosis in men; or
- Glucocorticoid-induced osteoporosis in men or women (daily dose greater than or equal to 5mg prednisone or equivalent for at least 3 months); and
- ONE of the following:
- Member is high risk for fracture defined by ONE of the following:
- History of osteoporotic fractures (low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm); or
- At least two risk factors for a fracture (e.g., endocrine disorders, gastrointestinal disorders, use of medications associated with low bone mass or bone loss such as corticosteroids); or
- Member has a T score of at least -2.5 standard deviations below the young adult mean (T-score ≤ -2.5); or
- Inadequate response or inability to tolerate ONE of the following osteoporosis therapies:
- Bisphosphonates; or
- Hormone replacement therapy; or
- Selective estrogen receptor modulators (SERMs); or
- Calcitonin salmon (Miacalcin); or
- Denosumab (Prolia); and
- For Forteo® only, inadequate response or inability to tolerate Teriparatide® manufactured by Alvogen
Initial Authorization duration: 12 months
REAUTHORIZATION CRITERIA: Teriparatide (Forteo®) is medically necessary when BOTH of the following are met: - Documentation of positive clinical response; and
- ONE of the following:
- Cumulative lifetime therapy does not exceed 2 years; or
- For Forteo® only, member remains at or has returned to having a high risk for fracture despite a total of 24 months of use for parathyroid hormones
Reauthorization duration: 12 months
Postmenopausal osteoporosis INITIAL CRITERIA: Abaloparatide (Tymlos™) or teriparatide (Forteo®) is medically necessary when ALL of the following are met: - The member is 18 years of age or older; and
- Diagnosis of postmenopausal osteoporosis; and
- ONE of the following:
- Member is high risk for fracture defined by ONE of the following:
- Member has a T score of at least -2.5 standard deviation below the young adult mean (T-score ≤ -2.5); or
- History of osteoporotic fractures (low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm); or
- At least two risk factors for a fracture (e.g., endocrine disorders, gastrointestinal disorders, use of medications associated with low bone mass or bone loss such as corticosteroids); or
- Inadequate response or inability to tolerate ONE of the following osteoporosis therapies:
- Bisphosphonates; or
- Hormone replacement therapy; or
- Selective-estrogen receptor modulators (SERMs); or
- Calcitonin-salmon (Miacalcin®); or
- Denosumab (Prolia®); and
- For Forteo® only, inadequate response or inability to tolerate Teriparatide® manufactured by Alvogen
Initial Authorization duration: 12 months
REAUTHORIZATION CRITERIA: Abaloparatide (Tymlos™) or teriparatide (Forteo®) is medically necessary when BOTH of the following are met: - Documentation of positive clinical response; and
- ONE of the following:
- Cumulative lifetime therapy does not exceed 2 years; or
- For Forteo® only, member remains at or has returned to having a high risk for fracture despite a total of 24 months of use for parathyroid hormones
Reauthorization duration: 12 months
Increase bone density in men with osteoporosis at high risk for fracture INITIAL CRITERIA: Abaloparatide (Tymlos®) is medically necessary when ALL of the following are met: - Diagnosis of primary or hypogonadal osteoporosis; and
- The member is 18 years of age or older; and
- Both of the following:
- Bone mineral density (BMD) T-score of -2.5 or lower in the lumbar spine, femoral neck, total hip, or radius (one-third radius site); and
- One of the following:
- History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm; or
- Inadequate response or inability to tolerate at least one osteoporosis treatment (e.g., alendronate, zoledronic acid, Prolia [denosumab])
Initial authorization duration: 12 months REAUTHORIZATION CRITERIA: Abaloparatide (Tymlos®) is medically necessary when BOTH of the following are met: - Documentation of positive clinical response; and
- Cumulative lifetime therapy does not exceed 2 years
Reauthorization duration: 12 months
* Coverage duration of Teriparatide and Tymlos™ is limited to 730-day supply max per lifetime. All other treatment durations are considered Experimental/Investigational.
**Osteoporosis defined as T score of the individual's bone mineral density (BMD) is at least -2.5 standard deviations below the young adult mean OR history of osteoporotic fracture (i.e. hip, spine, etc.)
| | | | 18 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:11 AM | srv_ppsgw_P | | | Brand Name | Generic Name
| Tymlos™
| abaloparatide | | Forteo® | teriparatide |
| Tymlos™, Forteo® | abaloparatide, teriparatide | | 486 | | | 1/1/2025 | Rx.01.148 | Commercial | VanHorn, Lynnsey | Q3-2024 | Actinic keratoses (AKs or solar keratoses) are keratotic macules, papules, or plaques resulting from the intraepidermal proliferation of atypical keratinocytes in response to prolonged exposure to ultraviolet radiation. AKs are a concern because the majority of cutaneous squamous cell carcinoma (SCCs) arise from pre-existing AKs, and AKs that will progress to SCC cannot be distinguished from AKs that will spontaneously resolve or persist. Cutaneous T cell lymphoma (CTCL) describes a heterogeneous group of neoplasms of skin-homing T cells. CTCL represent approximately 75 to 80 percent of all primary cutaneous lymphomas. Mycosis fungoides (MF) and primary cutaneous CD30+ lymphoproliferative disorders (LPD) account for approximately 90 percent of CTCL. Ingenol mebutate (Picato®) is indicated for the topical treatment of actinic keratosis (AK). Ingenol mebutate (Picato®) is an inducer of cell death. The mechanism of action by which ingenol mebutate gel induces cell death in treating AK lesions is unknown. Diclofenac 3% gel (Solaraze®) is indicated for the topical treatment of AK. The mechanism of action of diclofenac 3% gel (Solaraze®) in the treatment of AK is unknown. Tirbanibulin (Klisyri™) is indicated for the topical treatment of actinic keratosis on the face or scalp. Tirbanibulin is a microtubule inhibitor. The mechanism of action of KLISYRI for the topical treatment of actinic keratosis is unknown. Imiquimod (Zyclara™) is indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or baling scalp in immunocompetent adults and the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.
Imiquimod is a Toll-like receptor 7 agonist. The mechanism of action of Zyclara™ in treating AK and EGW lesions is unknown. | The intent of this policy is to communicate the medical necessity criteria for ingenol mebutate (Picato®) diclofenac 3% (Solaraze®) tirbanibulin (Klisyri®), and imiquimod (Zyclara™) as provided under the member's prescription drug benefit.
| Actinic Keratosis
INITIAL CRITERIA Ingenol mebutate (Picato®), diclofenac 3% (Solaraze®) gel, imiquimod (Zyclara®) 3.75%, 2.5%, or tirbanibulin (Klisyri®) is medically necessary when BOTH of the following are met: - Diagnosis of actinic keratosis; and
- Member is 18 years of age or older; and
- ONE of the following:
- For imiquimod (Zyclara®) 3.75%, 2.5% only, inadequate response or inability to tolerate imiquimod 5%; or
- For tirbanibulin (Klisyri®) only, inadequate response or inability to tolerate BOTH of the following generics:
- Fluorouracil; and
- Imiquimod
Initial authorization duration: - 30 days for tirbanibulin (Klisyri®), ingenol mebutate (Picato®) imiquimod (Zyclara®) 3.75%, 2.5%.
- 3 months for diclofenac 3% (Solaraze®)
REAUTHORIZATION CRITERIA Ingenol mebutate (Picato®), diclofenac 3% (Solaraze®) gel, imiquimod (Zyclara®) 3.75%, 2.5%, or tirbanibulin (Klisyri®) is medically necessary when there is documentation of a diagnosis of actinic keratosis at a different site.
Reauthorization duration: - 30 days for tirbanibulin (Klisyri®), ingenol mebutate (Picato®) imiquimod (Zyclara®) 3.75%, 2.5%.
- 3 months for diclofenac 3% (Solaraze®)
Genital warts INITIAL CRITERIA Imiquimod (Zyclara®) 3.75% is medically necessary when BOTH of the following are met: - Diagnosis of genital warts; and
- Member is 12 years of age or older; and
- Inadequate response or inability to tolerate imiquimod 5%
Initial authorization duration: 30 days
REAUTHORIZATION CRITERIA Imiquimod (Zyclara®) 3.75% is medically necessary when there is documentation of positive clinical response to therapy.
Reauthorization duration: 30 days
| Solaraze® (diclofenac 3%): Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial and stroke, which can be fatal. This risk may occur in treatment and may increase with duration of use. Solaraze® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
| | Berman B. Treatment of actinic keratosis. UpToDate. July 2024. Available at: https://www.uptodate.com/contents/treatment-of-actinic-keratosis?source=search_result&search=actinic%20keratosis&selectedTitle=1~46. Accessed October 09, 2024. Picato® (ingenol mebutate) [package insert]. Parsippany, NJ. Leo Pharma Inc. March 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5accc7a5-8209-4680-b0ae-2a6963500419&type=display. Accessed October 09, 2024. Solaraze® (diclofenac 3%) [package insert]. Melville, NY. PharmaDerm. April 2016. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=89a7bfbd-051f-4d87-a642-96b0df81b8e2&type=display. Accessed October 09, 2024. Willemze R. Classification of primary cutaneous lymphomas. UpToDate. August 2024. Available at: https://www.uptodate.com/contents/classification-of-primary-cutaneous-lymphomas?source=machineLearning&search=CTCL&selectedTitle=7~106§ionRank=1&anchor=H474649238#H474649238. Accessed October 09, 2024. Klisyri™ (tirbanibulin) [package insert]. Exton, PA: Almirall; June 2024. Available from: https://klisyrihcp.com/assets/klisyri-prescribing-information.pdf. Accessed October 09, 2024.
Zyclara™ (imiquimod) [package insert]. Bridgewater, NJ: Bausch Health US, LLC; October 2024. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=28cd9b5b-680b-480f-b33d-9c5b52bbf03d. Accessed October 09, 2024.
| 14 | 9/12/2024 | 9/12/2025 | 1/1/2025 1:12 AM | srv_ppsgw_P | Off-Label Use policy Rx.01.33
| | Brand Name | Generic Name | | Picato® | ingenol mebutate | Solaraze® Klisyri™ | diclofenac 3% Tirbanibulin | | Zyclara™ | Imiquimod |
| Picato®, Solaraze®,Klisyri®, and Zyclara™ | ingenol mebutate, diclofenac 3%, tirbanibulin, and imiquimod | | 487 | | | 1/1/2025 | Rx.01.267 | Commercial | VanHorn, Lynnsey | Q3-2024 | Testing for genetic mutations in the PIK3CA gene is done at initial MBC diagnosis if tumor is HR+/HER2- following progression on or after an endocrine-based regimen. This gene effects cell growth and development and can contribute to a worse prognosis for patients. Knowledge of the presence of this mutation can inform providers in their treatment selection for these patients.
Alpelisib is a small-molecule phosphatidylinositol-3-kinase (PI3K) inhibitor with selective (and strong) activity against PI3Kα (André 2019). Mutations in the gene encoding the catalytic α-subunit of PI3K (PI3KCA) lead to activation of PI3Kα and Akt-signaling, cellular transformation, and tumor generation. Alpelisib inhibits phosphorylation of PI3K downstream targets (including Akt) and demonstrated activity in cell lines harboring a PIK3CA mutation. When compared with either agent alone, the combination of alpelisib with fulvestrant has synergistic antitumor activity in PIK3CA-mutated, estrogen receptor-positive models.
Activating mutations in PIK3CA may induce a spectrum of overgrowths/malformations comprising clinically recognizable disorders commonly known as PIK3CA-related overgrowth spectrum (PROS). In an animal model PROS phenotype (congenital lipomatous overgrowth, vascular malformations, epidermal nevi, scoliosis/skeletal and spinal syndrome [CLOVES]), alpelisib inhibited the PI3K pathway, resulting in prevention or improvement of organ abnormalities associated with the disease; findings were reversed following alpelisib withdrawal
Breast cancer, advanced or metastatic: Treatment (in combination with fulvestrant) of HR-positive, HER2-negative, PIK3CA-mutated (as detected by an approved test), advanced or metastatic breast cancer in males and postmenopausal females following progression on or after an endocrine-based regimen.
PIK3CA-related overgrowth spectrum: Treatment of severe manifestations of PIK3CA-related overgrowth spectrum in patients ≥2 years of age who require systemic therapy.
| The intent of this policy is to communicate the medical necessity criteria for Alpelisib (Vijoice®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Alpelisib (Vijoice) is medically necessary when ALL of the following are met: - Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS); and
- Documentation of mutation in the PIK3CA gene; and
- Member is 2 years of age or older; and
- Documentation of severe clinical manifestations (e.g., Congenital Lipomatous Overgrowth, Vascular malformations, Epidermal nevi, Scoliosis/skeletal and spinal [CLOVES], Facial Infiltrating Lipomatosis [FIL], Klippel-Trenaunay Syndrome [KTS], Megalencephaly-Capillary Malformation Polymicrogyria [MCAP]); and
- Prescribed by or in consultation with a provider who specialized in the treatment of PROS
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA Alpelisib (Vijoice®) is medically necessary when ALL of the following are met: - Documentation of positive clinical response to therapy (e.g., radiological response defined as a ≥ 20% reduction from baseline in the sum of target lesion volume); and
- Prescribed by or in consultation with a provider who specializes in the treatment of PROS
Reauthorization duration: 12 months
| | | André F, Ciruelos E, Rubovszky G, et al; SOLAR-1 Study Group. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019;380(20):1929-1940.[PubMed 31091374] Venot Q, Blanc T, Rabia SH, et al. Targeted therapy in patients with PIK3CA-related overgrowth syndrome. Nature. 2018;558(7711):540-546. doi:10.1038/s41586-018-0217-9[PubMed 29899452] Vijoice® (alpelisib) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2024. Available from: https://www.novartis.com/us-en/sites/novartis_us/files/vijoice.pdf. Accessed October 09, 2024.
| 3 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:12 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand Name | Generic Name | | Vijoice® | Alpelisib |
| Vijoice® | Alpelisib | | 488 | | | 1/1/2025 | Rx.01.256 | Commercial | VanHorn, Lynnsey | Q3-2024 | Graft-versus-host disease (GVHD) can develop after allogeneic hematopoietic cell transplant (HCT), when immune cells from a non-identical donor (the graft) initiate an immune reaction against a transplant recipient (the host). Chronic GVHD is a syndrome of variable clinical features that resembles autoimmune and other immunologic disorders (eg, scleroderma, Sjögren's syndrome, primary biliary cirrhosis, bronchiolitis obliterans). Clinical manifestations may be widespread, or they may be restricted to a single organ or site. The primary clinical manifestations are skin involvement (resembling lichen planus or cutaneous scleroderma), dry oral mucosa, gastrointestinal tract ulcerations and sclerosis, elevated serum bilirubin, and bronchiolitis obliterans. Chronic GVHD is a major cause of morbidity and mortality after allogeneic HCT, which worsen with increasing disease severity. Patients have impaired physical, social, and psychological well-being and impaired quality of life. Belumosudil is an inhibitor of rho-associated, coiled-coil containing protein kinase (ROCK) which inhibits ROCK2 and ROCK1 with IC50 values of approximately 100 nM and 3 μM, respectively. Belumosudil down- regulated proinflammatory responses via regulation of STAT3/STAT5 phosphorylation and shifting Th17/Treg balance in ex-vivo or in vitro-human T cell assays. Belumosudil also inhibited aberrant pro-fibrotic signaling, in vitro. In vivo, belumosudil demonstrated activity in animal models of chronic GVHD. REZUROCK is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
| The intent of this policy is to communicate the medical necessity criteria for Belumosudil (Rezurock™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Belumosudil (Rezurock™) is medically necessary when ALL of the following are met: - Diagnosis of chronic graft-versus-host disease; and
- Member is 12 years of age or older; and
- Inadequate response or inability to tolerate two or more lines of systemic therapy (e.g., corticosteroids, mycophenolate, etc.); and
- Prescribed by or in consultation with one of the following:
- Hematologist; or
- Oncologist; or
- Physician experienced in the management of transplant patients
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA Belumosudil (Rezurock™) is medically necessary if member does not show evidence of progressive disease while on therapy
Reauthorization duration: 2 years
| | | Rezurock™ [package insert]. Warrendale, PA: Kadmon Pharmaceuticals. April 2024. Available at: https://www.rezurock.com/full-prescribing-information.pdf. Accessed October 09, 2024.
Zeiser R. Clinical manifestations and diagnosis of chronic graft-versus-host disease. UpToDate website. Last updated February 2024. Available at http://www.uptodate.com/. Accessed October 09, 2024.
| 4 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:12 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | RezurockTM | Belumosudil |
| Rezurock™ | Belumosudil | | 489 | | | 1/1/2025 | Rx.01.10 | Commercial | VanHorn, Lynnsey | Q3-2024 | Hyperammonemia is a urea cycle disorder due to a deficiency of an enzyme in the pathway that can cause life-threatening metabolic decompensations in infancy. Survivors frequently have severe neurologic injury. Frequent vomiting and poor appetite with food refusal and protein aversion are common in patients with UCD. In newborns, central hyperventilation leading to respiratory alkalosis is an early sign of hyperammonemia. Infants become symptomatic after feeding in which initial signs include somnolence, inability to maintain normal body temperature, poor feeding followed by vomiting lethargy and coma.
N-acetylglutamate synthetase (NAGS) deficiency is a rare, autosomal, recessive genetic disorder in which lack of NAGS enzyme leads to hyperammonemia (excess ammonia). NAGS deficiency is one of several urea cycle disorders.
Carglumic acid (Carbaglu®) is a synthetic structural analogue of N-acetylglutamate (NAG), which is produced from glutamate and acetyl-CoA in a reaction catalyzed by N-acetylglutamate synthase (NAGS), a mitochondrial liver enzyme. NAG acts as an essential allosteric activator of carbamoyl phosphate synthetase 1 (CPS 1) in liver mitochondria. CPS 1 catalyzes the first reaction of the urea cycle, . NAG is the product of NAGS, a mitochondrial liver enzyme. Carglumic acid acts as a CPS 1 activator in NAGS deficiency patients , thereby facilitating ammonia detoxification and urea production by removing the block in the urea cycle Carglumic Acid (Carbaglu®) is indicated for adjunctive therapy in the treatment of acute hyperammonemia due to NAGS deficiency, propionic acidemia (PA) or methylmalonic acidemia (MMA), and maintenance therapy of chronic hyperammonemia due to the deficiency of the hepatic enzyme NAGS.
| The intent of this policy is to communicate the medical necessity criteria for carglumic acid (Carbaglu®) as provided under the member's prescription drug benefit.
| Acute Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency APPROVAL CRITERIA: Carglumic Acid (Carbaglu®) is medically necessary when all of the following are met: - Diagnosis of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency; and
- Medication will be used as adjunctive therapy to other ammonia lowering therapies (e.g., protein restriction, ammonia scavengers, dialysis)
- Prescribed by or in consultation with a provider who specializes in the treatment of metabolic disorders
Authorization duration: 3 months
Acute Hyperammonemia due to Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA) APPROVAL CRITERIA: Carglumic Acid (Carbaglu®) is medically necessary when all of the following are met: - Diagnosis of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA); and
- Medication will be used as adjunctive therapy to other ammonia lowering therapies (e.g., intravenous glucose, insulin, protein restriction, dialysis); and
- Patient's plasma ammonia level is greater than or equal to 50 micromol/L; and
- Medication will be used for a maximum duration of 7 days; and
- Prescribed by or in consultation with a provider who specializes in the treatment of metabolic disorders
Authorization duration: 3 months Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency INITIAL CRITERIA: Carglumic Acid (Carbaglu®) is medically necessary when all of the following are met: - Diagnosis of chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency; and
- NAGS deficiency has been confirmed by genetic/mutational analysis; and
- Medication will be used as maintenance therapy; and
- Prescribed by or in consultation with a provider who specializes in the treatment of metabolic disorders
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Carglumic acid (Carbaglu®) is medically necessary when there is documentation of positive clinical response to therapy (e.g., plasma ammonia level within the normal range).
Reauthorization duration: 2 years
| | | Carbaglu® [package insert]. Lebanon NJ. Recordati Rare Diseases, Inc. January 2024. Available at: hhttps://www.carbaglu.com/wp-content/uploads/Carbaglu-Prescribing-Information-Current.pdf. Accessed October 10, 2024. N-acetylglutamate synthetase deficiency. National organization for rare disorders. Available at: http://rarediseases.org/rare-diseases/n-acetylglutamate-synthetase-deficiency/. Accessed October 10, 2024. Lee B. Urea cycle disorders: clinical features and diagnosis. UpToDate website. October 2023. Available at http://www.uptodate.com/. Accessed Accessed October 10, 2024.
| 15 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:12 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Carbaglu® | Carglumic Acid |
| Carbaglu® | Carglumic acid | | 490 | | | 1/1/2025 | Rx.01.22 | Commercial | VanHorn, Lynnsey | Q3-2024 | Individuals, who are transfusion-dependent, receive excess iron with each transfusion. In non-transfusion-dependent thalassemia (NTDT), elevated iron levels are related to suppression of hepcidin levels, increased intestinal iron absorption, and increased release of recycled iron from the reticuloendothelial system. The excess iron accumulates in various tissues, including cardiac, liver, pulmonary, and endocrine glands, due to lack of an active mechanism to excrete iron. The goal of iron chelation therapy in iron overload is to reduce iron levels, prevent complications, and reduce morbidity.
Deferasirox (Exjade®/ Jadenu®) is indicated for the treatment of transfusional hemosiderosis (chronic iron overload due to blood transfusions) in individuals who are 2 years of age or older and for the treatment of chronic iron overload in patients 10 years of age and older with NTDT syndromes and with a liver iron concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/ g dw) and a serum ferritin greater than 300 mcg/L.
Deferiprone (Ferriprox®) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
Deferasirox (Exjade®/Jadenu®) is an orally active chelator that is selective for iron (as Fe3+). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper, there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.
Deferiprone (Ferriprox®) is a chelating agent with an affinity for ferric ion (iron III). Deferiprone binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable over a wide range of pH values.
| The intent of this policy is to communicate the medical necessity criteria for deferasirox (Exjade®/ Jadenu®) and deferiprone (Ferriprox®) as provided under the member's prescription drug benefit.
| Chronic iron overload in blood transfusions dependent anemia INITIAL CRITERIA: Deferasirox (Exjade®/Jadenu®) is medically necessary when ALL of the following are met: - Diagnosis of chronic iron overload due to blood transfusions; and
- Member is 2 years of age or older; and
- Serum ferritin levels are consistently greater than 1000 mcg/L (as demonstrated with at least two lab values within two months prior to treatment)
- For Brand Exjade and Brand Jadenu only, inadequate response or inability to tolerate generic deferasirox
Initial authorization duration: 12 months
CONTINUATION CRITERIA: Deferasirox (Exjade®/Jadenu®) is medically necessary there is documentation of a decreased serum ferritin level compared with baseline level for transfusion dependent anemia.
Continuation duration: 2 years INITIAL CRITERIA: Deferiprone (Ferriprox®) is medically necessary when all of the following are met: - Diagnosis of transfusional iron overload due to Sickle Cell disease or other transfusion-dependent anemia; and
- Member is 3 years of age or older; and
- Inadequate response or inability to tolerate one of the following chelation therapy:
- Generic deferoxamine; or
- generic deferasirox; and
- For Brand Ferriprox tablets only, Inadequate response or inability to tolerate generic deferiprone tablets; and
- Current chelation therapy is inadequate
Initial authorization duration: 12 months
CONTINUATION CRITERIA: Deferiprone (Ferriprox®) is medically necessary when there is documentation of positive clinical response to therapy (e.g., decline in serum ferritin levels from baseline).
Continuation duration: 2 years
Chronic iron overload in non-transfusion-dependent Thalassemia Syndrome INITIAL CRITERIA: Deferasirox (Exjade®/Jadenu®) is medically necessary when ALL of the following are met: - Diagnosis of chronic iron overload in Non-Transfusion-Dependent Thalassemia Syndromes; and
- Member is 10 years of age or older; and
- Serum ferritin levels are consistently greater than 300 mcg/L and liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) (as demonstrated with at least two lab values within 2 months prior to treatment)
Initial authorization duration: 12 months
CONTINUATION CRITERIA: Deferasirox (Exjade®/Jadenu®) is medically necessary when there is documentation of a decreased serum ferritin level compared with the baseline level or reduction in LIC (liver iron concentration) for non-transfusion dependent Thalassemia Syndrome
Continuation duration: 2 years
INITIAL CRITERIA: Deferiprone (Ferriprox®) is medically necessary when ALL of the following are met: - Diagnosis of transfusional iron overload due to Thalassemia Syndrome; and
- Member is 3 years of age or older; and
- Inadequate response or inability to tolerate one of the following chelation therapy:
- Generic deferoxamine; or
- Generic deferasirox; and
- For Brand Ferriprox tablets only, Inadequate response or inability to tolerate generic deferiprone tablets; and
- Current chelation therapy is inadequate
Initial authorization: 12 months
CONTINUATION CRITERIA: Deferiprone (Ferriprox®) is medically necessary when there is documentation of positive clinical response to therapy (e.g., greater than or equal to 20% decline in serum ferritin levels from baseline).
Continuation duration: 2 years
| Deferasirox (Exjade/ Jadenu) Renal failure: Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Deferasirox is contraindicated in adults and pediatric patients with eGFR less than 40 ml/min/1.73m2. Use caution in pediatric patients with eGFR between 40 and 60 ml/min/1.3m2. For patients with renal impairment (eGFR 40-60 ml/min/1.73m2) reduce starting dose by 50%. Measure serum creatinine and determine creatinine clearance (CrCl)prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly thereafter. Monitor serum ferritin monthly to evaluate for overchelation. Use the minimum dose to establish and maintain a low iron burden. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine. Interrupt deferasirox therapy when acute kidney injury is suspected and during volume depletion. Hepatic failure: Deferasirox can cause hepatic injury including hepatic failure and death. Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter. Avoid use of deferasirox in patients with severe (Child-Pugh class C) hepatic impairment and reduce the dose in patients with moderate (Child-Pugh class B) hepatic impairment. Interrupt deferasirox therapy when acute liver injury is suspected and during volume depletion. GI hemorrhage: Deferasirox can cause GI hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts. Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage. Deferiprone (Ferriprox) Agranulocytosis/Neutropenia: Deferiprone can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. Measure the absolute neutrophil count (ANC) before starting deferiprone therapy and monitor the ANC weekly during therapy. Interrupt deferiprone therapy if neutropenia develops. If infection develops, interrupt deferiprone and monitor the ANC more frequently. Advise patients taking deferiprone to report immediately any symptoms indicative of infection. For neutropenia, instruct the patient to immediately discontinue deferiprone and all other medications with potential to cause neutropenia. Obtain a complete blood count (CBC), white blood count (WBC corrected for the presence of nucleated red blood cells, ANC and a platelet count daily until recovery. For agranulocytosis, consider hospitalization and other clinically appropriate management.
| | | 16 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:12 AM | srv_ppsgw_P | Off-Label Use policy Rx.01.33
| | Brand Name | Generic Name | | Exjade | Deferasirox | | Jadenu | Deferasirox | Ferriprox
| Deferiprone |
| Exjade®/Jadenu® and Ferriprox® | deferasirox and deferiprone | | 491 | | | 1/1/2025 | Rx.01.218 | Commercial | VanHorn, Lynnsey | Q3-2024 | The Continuous Glucose Monitors (CGMs) are indicated for use in individuals with type 1 diabetes who require insulin and need to be monitored for unexplained glycemic fluctuations and hypoglycemic unawareness. Hypoglycemic unawareness is the inability of an individual to notice and recognize symptoms of hypoglycemia while they are experiencing them.
CGMs devices are considered an adjunct to be used with a traditional blood glucose monitor. These adjunctive devices allow individuals to track glucose levels and detect episodes of high and low blood sugar in real-time on an ongoing basis. The device consists of a disposable subcutaneous sensor, an external transmitter, and an external receiver (monitor), which can be a stand-alone device or built into an insulin pump. Sensors are worn as indicated by the device manufacturer in accordance with US Food and Drug Administration (FDA) labeling and are replaced on an ongoing basis.
Depending on the device sensor longevity capability, a CGMs sensor measures interstitial glucose levels for 6 to 14 days. Use of this device requires the glucose sensor to be implanted subcutaneously, usually in the abdomen or in an area above the buttocks. The transmitter is connected to the sensor by an adhesive patch, and glucose signals are sent from the sensor to the receiver every five minutes. Interstitial glucose values appear on the receiver or mobile device, where they can be read and reviewed by the individual. This data may be stored and downloaded for analysis. CGMs devices also allow for customization of threshold settings, such as alarms, to detect high and low glucose levels.
The FDA has approved several CGMs devices to assist in analyzing glycemic trends in the ongoing evaluation and management of individuals with diabetes. The FDA requires that alterations to an individual's insulin dosage or therapy are made only after confirmation of blood glucose levels with a traditional blood glucose monitor.
| The intent of this policy is to communicate the medical necessity criteria for Continuous Glucose Monitors (Dexcom®, Medtronic®, Freestyle Libre) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Continuous glucose monitor (CGM) products (receivers, transmitters and sensors) are medically necessary when ALL of the following are met: - Diagnosis of diabetes; and
- Member is adherent to current diabetes treatment plan and participates in ongoing diabetes education and support; and
- One of the following:
- Member is treated with insulin; or
- Member is non-insulin treated and experiences significant hypoglycemia (e.g., recurrent, unexplained, severe [generally blood glucose levels <50 mg/dL] hypoglycemia or hypoglycemic unawareness); and
- For Freestyle Libre only, submission of documentation (e.g., chart notes) or paid claim history showing member had a minimum 90-day trial of Dexcom within the last 180 days
Initial authorization duration: 2 years.
REAUTHORIZATION CRITERIA: Continuous glucose monitor (CGM) products (receivers, transmitters and sensors) are medically necessary when ALL of the following are met: - Documentation that of a positive clinical response as evidenced by ONE of the following:
- Improvement in glycemic control (e.g., lower and/or maintain A1C levels); or
- Reduction or improvement in hypoglycemic events; and
- For Freestyle Libre only, submission of documentation (e.g., chart notes) or paid claim history showing member had a minimum 90-day trial of Dexcom within the last 180 days
Reauthorization duration: 2 years
| | | Dexcom® CGM. Available at: https://www.dexcom.com/continuous-glucose-monitoring. Accessed April 17, 2024. Freestyle Libre® CGM. Available at: https://www.freestyle.abbott/us-en/home.html. Accessed April 17, 2024. Medtronic® CGM. Available at: https://www.medtronicdiabetes.com/treatments/continuous-glucose-monitoring. Accessed April 17, 2024. Weinstock, R. Management of blood glucose in adults with type 1 diabetes mellitus. UpToDate website. Updated February 2021 www.uptodate.com. Accessed April 17, 2024.
| 8 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:13 AM | srv_ppsgw_P | Rx.01.33 Off-Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Dexcom® line of products | Medtronic® line of products | Freestyle® line of products | Dexcom® G5 Receivers
Dexcom® G6 Receivers
Dexcom® G7 Receiver
Dexcom® G5 Sensors
Dexcom® G6 Sensors
Dexcom® G7 Sensor
Dexcom® G5 Transmitter Kit
Dexcom® G6 Transmitter Kit | Guardian™ Connect Transmitter
Guardian™ Sensor
Enlite® Sensor
Eversense® Sensor/Holder | Freestyle Libre® 14 Day Reader
Freestyle Libre® 14 Day Sensor
Freestyle Libre® 2 Reader
Freestyle Libre® 2 Sensor
Freestyle Libre® 3 Sensor |
| Dexcom®, Medtronic®, Freestyle Libre | Continuous Glucose Monitors | | 492 | | | 1/1/2025 | Rx.01.291 | Commercial | VanHorn, Lynnsey | Q3-2024 | The Company utilizes a tiered cost-sharing structure for medications covered under the pharmacy benefit. Members should refer to their benefit booklet for more information.
Cost Share Exceptions for Women's Preventive Services The services listed in this policy are considered preventive care services when the criteria in this policy are met, when they are identified as preventive services in the Company's benefit contracts and when they are mandated by state or federal law. This policy supports the Women's Preventive Services (WPS) provision of Patient Protection and Affordable Care Act (PPACA). These products are available without cost-sharing with a prescription when provided by a participating retail or mail-order pharmacy. Based on the Women's Preventive Services (WPS) provision of Patient Protection and Affordable Care Act (PPACA) recommendation the following products are available at zero-dollar cost-share. All medications refer to generic, single ingredient products unless otherwise noted.
Category | Recommendation | Medication | CONTRACEPTIVES | The contraceptive methods for women currently identified by the FDA include: (1) sterilization surgery for women; (2) surgical sterilization implant for women; (3) implantable rod; (4) IUD copper; (5) IUD with progestin; (6) shot/injection; (7) oral contraceptives (combined pill); (8) oral contraceptives (progestin only); (9) oral contraceptives extended/continuous use; (10) patch; (11) vaginal contraceptive ring; (12) diaphragm; (13) sponge; (14) cervical cap; (15) condom; (16) spermicide; (17) emergency contraception; and (18) emergency contraception (Ella) | injection/shot, oral contraceptives, etonogestrel-ethinyl estradiol vaginal ring, diaphragms, sponge, cervical cap, condom, spermicide, emergency contraceptive, Ella®, Phexxi®. [Note: IUDs and implantable products are covered under the medical benefit. See referenced policy] |
Certain contraceptives have additional indications that are not addressed by the preventative care measure or have generic alternatives. Thus, the plan employs medical management to administer the requirements. The policy below outlines the process by which an exception can be obtained for medications that may apply to the WPS provision of the PPACA but are not coded as $0 at the point-of-sale.
|
| The intent of this policy is to communicate the medical necessity criteria for contraceptives formulary exception requests as provided under the member's prescription drug benefit.
| Non-formulary Exceptions: A non-formulary contraceptive is medically necessary for $0 cost-share when BOTH of the following are met: - The drug is described as a preventative medication identified by the Women's Preventive Services provision of the Patient Protection and Affordable Care Act (PPACA); and
- The prescriber has provided documentation indicating the requested product is medically necessary
Authorization duration: 1 year
$0 Cost-Share Override An exception to allow $0 cost-share for contraceptives covered on the formulary is medically necessary when BOTH of the following are met: - The drug is described as a preventative medication identified by the Women's Preventive Services provision of the Patient Protection and Affordable Care Act (PPACA); and
- The prescriber has provided documentation indicating the requested product is medically necessary
Authorization duration: 1 year
*This policy does not apply to the Premium Formulary.
| Cigarette Smoking and Serious Cardiovascular Events
Women over 35 years old who smoke should not use combination oral contraceptives.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. |
| | | 2 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:13 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.76 Quantity Level Limits for Pharmaceutical Covered under the Pharmacy Benefit 00.06.02 Preventive Care Services Medical Policy | | N/A | N/A | | 493 | | | 1/1/2025 | Rx.01.132 | Commercial | VanHorn, Lynnsey | Q3-2024 | Cushing's disease is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary tumor. Surgical intervention is required for optimal treatment of Cushing's disease. When surgery is delayed, contraindicated, or unsuccessful, medical therapy may be required. Cabergoline and pasireotide are medications that target the tumor and may help normalize urinary free cortisol. Pasireotide (Signifor®) exerts its pharmacological activity via binding to somatostation receptors (SSTRs). Pasireotide binds and activates the SSTRs, resulting in inhibition of ACTH secretion, which leads to decreased cortisol secretion. Osilodrostat (Isturisa®) is a cortisol synthesis inhibitor. It inhibits 11beta-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland.
Mifepristone (Korlym®) is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor. In addition, mifepristone appears to have little or no affinity for estrogen, muscarinic, histaminic, or monoamine receptors.
Levoketoconazole (Recorlev®) inhibits key steps in the synthesis of cortisol and testosterone, principally those mediated by CYP11B1 (11β hydroxylase), CYP11A1 (the cholesterol side-chain cleavage enzyme, the first step in the conversion of cholesterol to pregnenolone), and CYP17A1 (17α-hydroxylase).
Pasireotide (Signifor®) is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. Osilodrostat (Isturisa®) is indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
Mifepristone (Korlym®) indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.
Levoketoconazole (Recorlev®) is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative
| The intent of this policy is to communicate the medical necessity criteria for pasireotide (Signifor®), osilodrostat (Isturisa®), mifepristone (Korlym®), and levoketoconazole (Recorlev®) as provided under the member's prescription drug benefit.
| Cushing's Disease INITIAL CRITERIA Pasireotide (Signifor®) or osilodrostat (Isturisa®) is medically necessary when ALL of the following are met: - Diagnosis of Cushing's disease; and
- Member has failed surgery or is not a candidate for surgery; and
- Member is 18 years of age or older; and
- Prescribed by or in consultation with an endocrinologist; and
- For osilodrostat (Isturisa®) only, inadequate response or inability to tolerate pasireotide (Signifor® [LAR]); and
- For osilodrostat (Isturisa®) only, inadequate response or inability to tolerate oral ketoconazole
Initial Authorization duration: 6 months
REAUTHORIZATION CRITERIA Pasireotide (Signifor®) or osilodrostat (Isturisa®) is medically necessary when ALL of the following are met: - Documentation of positive clinical response to therapy (i.e., reduction in cortisol levels, improvement in signs or symptoms of the disease); and
- Prescribed by or in consultation with an endocrinologist
Reauthorization duration: 2 years
INITIAL CRITERIA Levoketoconazole (Recorlev®) is medically necessary when ALL of the following are met: - Diagnosis of Cushing's syndrome; and
- Member is 18 years of age or older; and
- Member is being treated for endogenous hypercortisolemia (e.g., pituitary adenoma, ectopic tumor, adrenal adenoma); and
- One of the following:
- Member is not a candidate for surgery; or
- Surgery has not been curative; and
- Inadequate response or inability to tolerate oral ketoconazole; and
- Prescribed by or in consultation with an endocrinologist
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA Levoketoconazole (Recorlev®) is medically necessary when ALL of the following are met: - Documentation of positive clinical response to therapy (i.e., decrease or normalization of urinary free cortisol (UFC) level, improvement in signs or symptoms of the disease); and
- Prescribed by or in consultation with an endocrinologist
Reauthorization duration: 2 years
Hyperglycemia secondary to Cushing's Syndrome INITIAL CRITERIA Mifepristone (Korlym®) is medically necessary when ALL of the following are met: - Hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance; and
- Member has failed surgery or is not a candidate for surgery; and
- Prescribed by or in consultation with an endocrinologist; and
- Member is not pregnant; and
- Member is 18 years of age or older
Initial Authorization duration: 6 months
REAUTHORIZATION CRITERIA Mifepristone (Korlym®) is medically necessary when ALL of the following are met: - Documentation of positive clinical response to therapy (e.g., improved, or stable glucose tolerance while on therapy); and
- Prescribed by or in consultation with an endocrinologist
Reauthorization duration: 2 years
| TERMINATION OF PREGNANCY
Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with KORLYM and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.
Levoketoconazole (Recorlev®)
HEPATOTOXICITY AND QT PROLONGATION
Cases of hepatotoxicity with fatal outcome or requiring liver transplantation have been reported with oral ketoconazole. Some patients had no obvious risk factors for liver disease.RECORLEV is associated with serious hepatotoxicity. Evaluate liver enzymes prior to and during treatment.
RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may result in life threatening ventricular dysrhythmias such as torsades de pointes. Perform ECG prior to and during treatment.
| | Nieman LK. Medical therapy of hypercortisolism (Cushing's syndrome). UpToDate. August 2022. Available at: https://www.uptodate.com/contents/medical-therapy-of-hypercortisolism-cushings-syndrome?source=search_result&search=cushings%20disease&selectedTitle=8~100#H1. Accessed October 11, 2024. Nieman LK. Overview of the treatment if Cushing's syndrome. UpToDate. November 2021. Available at: https://www.uptodate.com/contents/overview-of-the-treatment-of-cushings-syndrome?source=search_result&search=cushings%20disease%20management&selectedTitle=1~100#H4. Accessed October 11, 2024. Isturisa® (osilodrostat) [prescribing information]. Lebanon, NJ: Recordati Rare Disease, Inc.; March 2020. Available from: https://www.isturisa.com/pdf/isturisa-prescribing-information.pdf. Accessed October 11, 2024. Korlym® (mifepristone) [prescribing information]. Menlo Park, CA: Corcept Therapeutics Inc.; November 2019. Available from: https://www.korlym.com/wp-content/uploads/2018/01/K-00017-NOV-2019_electronic-PI_r8_FINAL.pdf. Accessed October 11, 2024. Recorlev® (levoketoconazole) [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc.; December 2021. Available from: https://www.recorlev.com/full-prescribing-information.pdf. Accessed October 11, 2024. Signifor® (pasireotide) [package insert]. East Hanocer, NJ. Novartis Pharmaceuticals Corporation. June 2020. Available at: https://www.signiforlar.com/pdf/signifor-lar-pi.pdf. Accessed October 11, 2024.
| 13 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:13 AM | srv_ppsgw_P | Off-Label Use policy Rx.01.33 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit Rx.01.76
|
| Brand name | Generic name | | Signifor® | PasireotideIsturisa | | Isturisa® | Osilodrostat | | Korlym® | Mifepristone | | Recorlev® | Levoketoconazole |
| Signifor®, Isturisa®, Korlym®, and Recorlev® | Pasireotide, Osilodrostat, Mifepristone, and Levoketoconazole | | 494 | | | 1/1/2025 | Rx.01.181 | Commercial | VanHorn, Lynnsey | Q3-2024 | Cells that rapidly divide such as bone marrow and myeloid cells require vitamin B12 to mature and proliferate. Vitamin B12 is necessary for hematopoiesis, nucleoprotein synthesis, and myelin synthesis. Additionally, it is required for fat and carbohydrate breakdown and protein synthesis. Vitamin B12 is bound to protein rich foods and comes from the diet. Hydrochloric acid and gastric protease break it down into its free form. The free form of vitamin B12 must be combined with intrinsic factor, which is produced by gastric parietal cells, in order to be absorbed in the distal ileum. Pernicious anemia is an autoimmune disease that is associated with the destruction of the parietal cells that secrete intrinsic factor. The inability to absorb vitamin B12 results in a severe deficiency which, if left untreated, can lead to megaloblastic anemia, GI lesions, or neurologic defects. Cyanocobalamin is the most widely used form of vitamin B12 to treat and maintain normal hematologic status in patients with pernicious anemia. It has identical hematopoietic activity to the anti-anemic factor that is present in the liver. Cyancobalamin is also indicated as a supplement for other vitamin B12 deficiencies, such as dietary deficiency and malabsorption of vitamin B12, Cyanocobalamin is available in oral, sublingual, and injection dosage forms. Cyanocobalamin nasal spray, a new route of administration, provides an alternative route of administration for vitamin B12 deficiency.
Cyanocobalamin inhalation (Nascobal®) is indicated for: - Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.
- Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia.
- Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal.
| The intent of this policy is to communicate the medical necessity criteria for cyanocobalamin inhalation (Nascobal®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Cyanocobalamin inhalation (Nascobal®) is medically necessary when ALL of the following are met: - Diagnosis of ONE of the following:
- Pernicious anemia in members requiring maintenance therapy who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement; or
- Dietary deficiency of vitamin B12 due to strict vegetarian diet; or
- Malabsorption of vitamin B12 due to a structural or functional damage to the stomach or ileum; or
- Inadequate secretion of intrinsic factor; or
- Competition for vitamin B12 by intestinal parasites or bacteria (e.g., tapeworm, blind loop syndrome); or
- Inadequate utilization of vitamin B12 (e.g., antimetabolites are employed in treatment of neoplasia); and
- Member is 18 years of age or older; and
- Inadequate response or inability to tolerate oral and sublingual cyanocobalamin or member has a documented diagnosis of trypanophobia (i.e., needle-phobia)
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA Cyanocobalamin inhalation (Nascobal®) is medically necessary when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
| | | Nascobal (cyanocobalamin inhalation) prescribing information. Spring Valley (NY). Par Pharmaceutical Companies, Inc. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021642Orig1s015lbl.pdf. Revised November 2018. Accessed October 11, 2024. National Institutes of Health: Vitamin B12 Dietary Supplement Fact Sheet [Internet]. Bethesda (MD):National Institutes of Health; [updated 2020 March 30]. Available from: https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/. Accessed October 11, 2024. Schrier SL. Clinical manifestations and diagnosis of vitamin B12 and folate deficiency. UpToDate website. Last updated September 29, 2022. Available at: http://www.uptodate.com/. Accessed October 11, 2024. Schrier SL. Causes and pathophysiology of vitamin B12 and folate deficiencies. UpToDate website. Last updated June 16, 2021. Available at http://www.uptodate.com/ Accessed October 11, 2024.
| 10 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:13 AM | srv_ppsgw_P | | Brand Name | Generic Name | Nascobal | Cyanocobalamin
|
| Nascobal® | Cyanocobalamin inhalation | | 495 | | | 1/1/2025 | Rx.01.211 | Commercial | VanHorn, Lynnsey | Q3-2024 | Endometriosis is defined as endometrial glands and stroma that occur outside the uterine cavity. Lesions are typically in the pelvis; however, they can occur at multiple sites. It affects many women throughout their lifetime and although it is considered nonmalignant, the pain and discomfort associated with the condition can be severe and debilitating.
Elagolix (Orilissa™) is a gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.
Elagolix (Orilissa™) is indicated for the management of moderate to severe pain associated with endometriosis.
| The intent of this policy is to communicate the medical necessity criteria for elagolix (Orilissa™) as provided under the member's prescription drug benefit.
| Elagolix (Orilissa™) is medically necessary when all of the following are met: - Diagnosis of moderate to severe pain associated with endometriosis; and
- Member is 18 years of age or older; and
- ONE of the following:
- Inadequate response or inability to tolerate BOTH of the following:
- One non-steroidal anti-inflammatory drug; and
- Contraceptives; or
- Member has had surgical ablation to prevent recurrence
Authorization duration: 2 years Coverage duration is limited to: - 24 months/ lifetime for 150mg tablet
- 6 months/ lifetime for 200mg tablet
All other treatment durations are considered Experimental/ Investigational.
| | | Elagolix (Orilissa™) [package insert]. North Chicago, IL. AbbVie, Inc. June 2023. Available from: https://www.rxabbvie.com/pdf/orilissa_pi.pdf. Accessed October 10, 2024.
Schenken, R. MD. Endometriosis: Pathogenesis, clinical features, and diagnosis. September 2024. UpToDate. Accessed October 10, 2024.
| 7 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:13 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Orilissa™ | Elagolix |
| Orilissa™ | Elagolix sodium | | 496 | | | 1/1/2025 | Rx.01.61 | Commercial | Oyenusi, Oluwadamilola | Q3-2024 | The Company utilizes a tiered cost-sharing structure for medications covered under the pharmacy benefit. Members should refer to their benefit booklet for more information.
Formulary Tier Exceptions The following tier exceptions requests will be considered:
Select Drug Formulary - Non-preferred drug to be covered at the:
- Preferred brand tier if the product is a brand medication; or
- Generic tier if the product is generic medication
- All other tiers are restricted to the benefit design and thus are not eligible for a tier exception
Value Formulary - Non-formulary medication to be covered at the highest level of cost share. These exceptions are not eligible for tier reduction.
- Non-preferred drug to be covered at the:
- Preferred brand tier if the product is a brand medication; or
- Generic tier if the product is generic medication
- All other tiers are restricted to the benefit design and thus are not eligible for a tier exception.
CHIP
- Non-preferred drug medication to be covered at the:
- Preferred brand tier if the product is a brand; or
- Generic tier if the product is generic
- Brand medication to be covered at the generic benefit level
The following tiers are defined by the benefit and are not eligible for a tier exception: - Specialty tier
- Preferred brand tier
- Generic tier
Definitions: - Biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product. A biosimilar may be used in patients who have previously been treated with the reference product (treatment-experienced), as well as in patients who have not previously received the reference product (treatment-naïve).
- Generic Equivalence is a term used for the generic drug which is created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine.
- Formulary alternative is a formulary covered drug alternative in the same pharmacological class as the requested drug.
Cost Share Exceptions for Preventive Care Services The services listed in this policy are considered preventive care services when the criteria in this policy are met, when they are identified as preventive services in the Company's benefit contracts and when they are mandated by state or federal law. This policy supports the preventative care services listed in the US Preventive Services Task Force (USPSTF) as A or B Recommendations. These products are available without cost-sharing with a prescription when provided by a participating retail or mail-order pharmacy. Based on the USPSTF recommendation the following products are available at zero-dollar cost-share. All medications refer to generic, single ingredient products unless otherwise noted.
| Category | Recommendation | Medication | | ASPIRIN | Pregnant Women Who Are At High Risk for Preeclampsia: The USPSTF recommends the use of low-dose aspirin (81 mg/d) as preventive medication after 12 weeks of gestation in pregnant females who are at high risk for preeclampsia. | aspirin 81mg or less | | TOBACCO CESSATION MEDICATION | Tobacco cessation medication is covered as a preventive service for all adults who use tobacco products. | Chantix ®, bupropion, Nicotrol®, generic nicotine gums and patches | | FOLIC ACID | The USPSTF recommends that all females planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid. | folic acid 400 mcg to 800 mcg (including generic prenatal vitamins with the above listed folic acid dose) | | FLUORIDE | In accordance with the preventive exam age schedule set forth by American Academy of Pediatrics (AAP)/Bright Futures, oral fluoride, up to 0.5mg, is covered as a preventive service for children ages 6 months to 16 years whose water supply is deficient in fluoride. | fluoride up to 0.5mg for children 6 months to 16 years of age | | BREAST CANCER CHEMO-PREVENTION | The USPSTF recommends that clinicians engage in shared, informed decision making with individuals who are at increased risk for breast cancer about medications to reduce their risk. For asymptomatic females 35 years or older without a prior diagnosis of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ, who are at increased risk for breast cancer and at low risk for adverse medication effects from breast cancer chemoprevention, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen. | tamoxifen 20mg | | BOWEL PREP FOR COLONOSCOPY | The USPSTF recommends screening for colorectal cancer starting at age 45 years and continuing until age 75 years. | PEG 3350- electrolyte, Gavilyte-C, Gavilyte-G, Gavilyte-N, PEG-prep, PEG 3350 powder for solution | | STATIN PREVENTIVE MEDICATION | The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (i.e., dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year risk of a cardiovascular event of 10% or greater. | lovastatin 10, 20, 40 mg | | HIV PrEP | Preexposure prophylaxis (PrEP) with effective antiretroviral therapy for persons who are at high risk of HIV acquisition | emtricitabine/tenofovir disoproxil fumarate 200mg-300mg, tenofovir 300mg
Descovy 200mg/25mg
|
Certain medications have additional indications that are not addressed by the preventative care measure, such as raloxifene, or have formulary alternatives. Thus, the plan employs medical management to administer the requirements. The policy below outlines the process by which an exception can be obtained for medications that may apply to the USPSTF recommendation but are not coded as $0 at the point-of-sale.
Refer to Contraceptives Formulary Exception policy for contraceptives coverage criteria.
| The intent of this policy is to communicate the medical necessity criteria for formulary exception requests as provided under the member's prescription drug benefit.
| Tier Exceptions: A non-preferred drug will be covered at the preferred tier for brand medications as listed below when there is documentation of inadequate response or inability to tolerate at least three preferred or generic tier alternatives in the same pharmacological class*. Reasonably equivalent therapeutic class alternatives will be considered when there are limited pharmacological class alternatives available. - Brand medication to preferred brand tier or
- Generic medication to generic tier
Non-formulary Exceptions: A non-formulary drug is medically necessary when ONE of the following are met: - $0 cost-share will apply when BOTH of the following are met:
- The drug is described as either a preventative medication identified by the US Preventive Services Task Force (USPSTF) or Women's Preventive Services provision of the Patient Protection and Affordable Care Act (PPACA); and if applicable; and
- For branded products, ALL of the following:
- Inadequate response or inability to tolerate the generic equivalent, if available; and
- Inadequate response or inability to tolerate a formulary alternative; and
- The prescriber has provided documentation indicating the requested product is medically necessary; or
- Appropriate level of cost share will apply when BOTH of the following are met:
- FDA approved, or compendia supported use; and
- ONE of the following:
- If biosimilar of the requested reference product or generic equivalent of the requested brand is available, both of the following:
- There is documentation of inadequate response or inability to tolerate biosimilar of the requested reference product or generic equivalent of the requested brand; and
- There is documentation of inadequate response or inability to tolerate at least two formulary alternatives in the same pharmacological class*. Reasonably equivalent therapeutic class alternatives will be considered when there are limited pharmacological class alternatives available. Safety edits (age and quantity limits) will apply to non-formulary requests; or
- If biosimilar of the requested reference product or generic equivalent of the requested brand is NOT available: there is documentation of inadequate response or inability to tolerate at least three formulary alternatives in the same pharmacological class*. Reasonably equivalent therapeutic class alternatives will be considered when there are limited pharmacological class alternatives available. Safety edits (age and quantity limits) will apply to non-formulary requests
CHIP (IN Focus ID 10093453)A brand medication may be covered at the generic benefit level when there is documentation of an inadequate response or inability to tolerate at least three generic formulary alternatives in the same pharmacological class*. Reasonably equivalent therapeutic class alternatives will be considered when there are limited pharmacological class alternatives available. Compounded Products:A non-preferred compounded product may be covered at the preferred (formulary) tier when there is an inadequate response or inability to tolerate/use all other formulary alternatives. Note: Compounded products are specially made products to meet the needs of an individual member and are not considered generics and thus not eligible for an exception to the generic tier. $0 Cost-Share Override An exception to allow no-cost share is medically necessary when: - The drug is described as either a preventative medication identified by the US Preventive Services Task Force (USPSTF) or Women's Preventive Services provision of the Patient Protection and Affordable Care Act (PPACA); and if applicable
- For branded products, ALL of the following:
- Inadequate response or inability to tolerate the generic equivalent, if available
- Inadequate response or inability to tolerate a formulary alternative
- The prescriber has provided documentation indicating the requested product is medically necessary
*If there are fewer than three alternatives, all alternatives in the pharmacological class must be considered. Premium Formulary: This policy does not apply to the premium formulary. Authorization duration: 1 years
| Truvada® (emtricitabine and tenofovir disoproxil fumarate), tenofovir
Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued Truvada® and tenofovir. Hepatic function should be monitored closely in HBV-infected patients who discontinue Truvada® and tenofovir. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Truvada® (emtricitabine and tenofovir disoproxil fumarate)
Truvada® used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug resistant HIV-1 variants have been identified with the use of Truvada® for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate Truvada® for HIV-1 PrEP if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed.
| | Bright Futures Period Schedule. Available at: https://downloads.aap.org/AAP/PDF/periodicity_schedule.pdf. Accessed September 18, 2024.
USPSTF A and B Recommendations by Date. US Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-a-and-b-recommendations?SORT=D&DESC=1. Updated September 2022. Accessed September 18, 2024.
Truvada® (emtricitabine and tenofovir disoproxil fumarate) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; June 2020. Available from: https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf. Accessed September 18, 2024.
Viread® (tenofovir disoproxil fumarate) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; April 2019. Available from: https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/viread/viread_pi.pdf. Accessed September 18, 2024.
| 28 | 9/12/2024 | 9/12/2025 | 1/1/2025 1:14 AM | srv_ppsgw_P |
Rx.01.33 Off Label Use
Rx.01.2 Applicable Age Edits
Rx.01.134 Compounded Product
Rx.01.76 Quantity Level Limits for Pharmaceutical Covered under the Pharmacy Benefit
Rx.01.197 Opioid Policy
Rx.01.291 Contraceptive Formulary Exception Policy
00.06.02 Preventive Care Services Medical Policy
| | N/A | N/A | | 497 | | | 1/1/2025 | Rx.01.246 | Commercial | VanHorn, Lynnsey | Q3-2024 | Molybdenum cofactor deficiency (MoCD) is characterized by early, rapidly progressive postnatal encephalopathy and intractable seizures, leading to severe disability and early death. MoCD is an autosomal recessive disorder that results from one of several single gene defects in the biosynthetic pathway of molybdenum cofactor. Approximately two-thirds of patients have MoCD type A, in which pathogenic variants in molybdenum cofactor synthesis gene 1 (MOSC1) result in the inability to synthesize the first intermediate in the pathway, cyclic pyranopterin monophosphate (cPMP), and the toxic accumulation of sulfites in blood and urine. Most patients present during the first few days of life with exaggerated startle, lethargy, intractable seizures, and autonomic dysfunction, a complex of symptoms that may resemble hypoxic-ischemic encephalopathy. Patients with MoCD Type A have mutations in the MOCS1 gene leading to deficient synthesis of the intermediate substrate, cPMP. Substrate replacement therapy with fosdenopterin provides an exogenous source of cPMP, which is needed for the activation of molybdenum-dependent enzymes, including SOX, an enzyme that reduces levels of neurotoxic sulfites. Nulibry™ (fosdenopterin) is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with MoCD Type A.
| The intent of this policy is to communicate the medical necessity criteria for Fosdenopterin (Nulibry™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Fosdenopterin (Nulibry™) is medically necessary when ALL of the following are met: - One of the following:
- Presumed diagnosis of molybdenum cofactor (MoCD) Type A deficiency; or
- Diagnosis of molybdenum cofactor (MoCD) Type A deficiency confirmed by genetic test; and
- Prescribed by or in consultation with a physician who specializes in the treatment of inherited metabolic disorders
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA Fosdenopterin (Nulibry™) is medically necessary when ALL of the following are met: - Diagnosis of molybdenum cofactor (MoCD) Type A deficiency as confirmed by genetic test [if not previously confirmed]; and
- Prescribed by or in consultation with a physician who specializes in the treatment of inherited metabolic disorders; and
- Document of positive clinical response to therapy (e.g., reduction in urine concentrations of S-sulfocysteine (SSC))
Reauthorization duration: 2 years
| | | Food and Drug Administration (FDA). Nulibry summary review. June 29, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214018Orig1s000IntegratedR.pdf. Accessed October 10, 2024.
Nulibry™ (fosdenopterin) [package insert], Boston, MA: Origin Biosciences, Inc; October 2022. Available from: https://www.nulibry.com/pdfs/nulibry-prescribing-information-v2.pdf. Accessed October 10, 2024.
Shellhaas, R. Treatment of neonatal seizures. March 2024. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Accessed October 10, 2024.
| 4 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:14 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Nulibry® | Fosdenopterin |
| Nulibry™ | Fosdenopterin | | 498 | | | 1/1/2025 | Rx.01.275 | Commercial | VanHorn, Lynnsey | Q3-2024 | Exenatide is a GLP-1 receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.
Byetta® (exenatide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Bydureon®/Bydureon BCise® (exenatide extended release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It is a 39-amino-acid modified peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. Tirzepatide enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose-dependent manner.
Mounjaro™ (tirzepatide) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated, and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.
Ozempic®, Rybelsus® (semaglutide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
Dulaglutide is a human GLP-1 receptor agonist. Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.
Trulicity® (dulaglutide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
Liraglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase by the stimulatory G-protein, Gs, in pancreatic beta cells. Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a delay in gastric emptying.
Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
Lixisenatide is a GLP-1 receptor agonist. Lixisenatide increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.
Adlyxin® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Medical claim history may be used to allow coverage.
| The intent of this policy is to communicate the medical necessity criteria for exenatide (Byetta®), exenatide extended release (Bydureon®/Bydureon BCise®), tirzepatide (Mounjaro™), semaglutide (Ozempic®, Rybelsus®), dulaglutide (Trulicity®), and liraglutide (Victoza®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Exenatide (Byetta®), exenatide ER (Bydureon®/Bydureon BCise®), tirzepatide (Mounjaro™), semaglutide (Ozempic®), semaglutide (Rybelsus®), dulaglutide (Trulicity®), liraglutide is medically necessary when ONE of the following are met:
- Submission of medical records (e.g., chart notes) confirming diagnosis of type 2 diabetes mellitus; or
- Submission of medical records (e.g., chart notes) confirming diagnosis of type 2 diabetes mellitus as evidenced by one of the following laboratory values:
- A1c greater than or equal to 6.5%; or
- Fasting plasma glucose (FPG) greater than or equal to 126mg/dL; or
- 2-hour plasma glucose (PG) greater than or equal to 200mg/dL during OGTT (oral glucose tolerance test); or
- Random plasma glucose greater than or equal to 200mg/dL
Initial authorization duration: 1 year INITIAL CRITERIA Brand Victoza® is medically necessary when ALL of the following are met:- ONE of the following:
- Submission of medical records (e.g., chart notes) confirming diagnosis of type 2 diabetes mellitus; or
- Submission of medical records (e.g., chart notes) confirming diagnosis of type 2 diabetes mellitus as evidence by one of the following laboratory values:
- A1c greater than or equal to 6.5%; or
- Fasting plasma glucose (FPG) greater than or equal to 126mg/dL; or
- 2-hour plasma glucose (PG) greater than or equal to 200mg/dL during OGTT (oral glucose tolerance test); or
- Random plasma glucose greater than or equal to 200mg/dL; and
- Submission of documentation (e.g., chart note) confirming inadequate response or inability to tolerate a minimum 90-day supply of TWO of the following:
- Bydureon/Bydureon BCise
- Byetta
- Ozempic
- Trulicity
- Rybelsus
- Mounjaro
Initial authorization duration: 1 year REAUTHORIZATION CRITERIA Exenatide (Byetta), exenatide ER (Bydureon/Bydureon BCise), tirzepatide (Mounjaro), semaglutide (Ozempic), semaglutide (Rybelsus), dulaglutide (Trulicity), liraglutide (Victoza) , is medically necessary when ALL of the following are met:- Documentation of positive clinical response to therapy (e.g., reduction in A1c); and
- For Brand Victoza only, submission of documentation (e.g., chart note) confirming inadequate response or inability to tolerate a minimum 90-day supply of TWO of the following:
- Bydureon/Bydureon BCise
- Byetta
- Ozempic
- Trulicity
- Rybelsus
- Mounjaro
Reauthorization duration: 1 year | Bydureon®/Bydureon BCise®, Mounjaro™, Ozempic®, Rybelsus®, Trulicity®, Victoza®
WARNING: RISK OF THYROID C-CELL TUMORS
GLP-1 receptor agonists and tirzepatide cause thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether it causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined. It is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.
| | Byetta® (exenatide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. December 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53d03c03-ebf7-418d-88a8-533eabd2ee4f. Accessed October 15, 2024. Bydureon BCise® (exenatide extended-release) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. May 2023. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d18cfc4-e0de-4814-a712-c1b7c504bff5. Accessed October 15, 2024. Mounjaro™ (tirzepatide) [prescribing information]. Indianapolis, IN: Lilly USA, LLC. May 2024. Available from: https://uspl.lilly.com/mounjaro/mounjaro.html#pi. Accessed October 15, 2024. Ozempic® (semaglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc. September 2023. Available from: https://www.novo-pi.com/ozempic.pdf. Accessed October 15, 2024. Rybelsus® (semaglutide) [prescription information]. Plainsboro, NJ: Novo Nordisk Inc. January 2024. Available from: Rybelsus PI (novo-pi.com). Accessed July 11, 2024
Trulicity® (dulaglutide) [prescribing information]. Indianapolis, IN: Eli Lilly and Company. January 2024. Available from: https://uspl.lilly.com/trulicity/trulicity.html#pi. Accessed October 15, 2024. Victoza® (liraglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc. July 2023. Available from: https://www.novo-pi.com/victoza.pdf. Accessed October 15, 2024.
| 6 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:14 AM | srv_ppsgw_P | Rx.01.33 Off Label Use
Rx.01.76 Quantity level limits for pharmaceuticals covered under the prescription drug benefit
| Brand Name | Generic Name | Byetta® | Exenatide | Bydureon®/Bydureon BCise® | Exenatide extended release | Mounjaro™ | Tirzepatide | Ozempic®; Rybelsus® | Semaglutide | Trulicity® | Dulaglutide | Victoza® | liraglutide | | |
| N/A | N/A | | 499 | | | 1/1/2025 | Rx.01.40 | Commercial | VanHorn, Lynnsey | Q3-2024 | Growth hormones are indicated for several disorders including growth failure associated with chronic renal insufficiency, Noonan syndrome, Prader-Willi Syndrome, Turner Syndrome, growth failure in children due to inadequate secretion of endogenous growth hormone, growth hormone deficiency in adults, growth failure in children born small for gestational age, idiopathic short stature, short bowel syndrome, short stature homeobox containing gene deficiency, and HIV wasting.
Biosynthetic growth hormone is used to replace natural growth hormone and is produced by recombinant DNA technology using either E coli bacteria or mammalian cell lines. Biosynthetic growth hormone goes by the generic name somatropin and has an amino acid sequence identical to human growth hormone from the pituitary gland. Somatropin is available under several different brand names.
| The intent of this policy is to communicate the medical necessity criteria for growth hormones as provided under the member's prescription drug benefit.
| A. Children with idiopathic short stature INITIAL CRITERIA Somatropin (Omnitrope®, Humatrope®, Genotropin®, Nutropin®[AQ], Norditropin®, or Zomacton®) is medically necessary when all of the following are met:
- Prescribed by an endocrinologist; and
- Height less than or equal to 2.25 standard deviations from the mean (1.2 percentile); and
- Documentation of growth velocity; and
- Epiphyses are not closed; and
- For Humatrope®, Genotropin®, Zomacton® only, inadequate response or inability to tolerate ONE of the following:
- Nutropin®/Nutropin AQ®; or
- Norditropin®; or
- Omnitrope®
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Omnitrope®, Humatrope®, Genotropin®, Nutropin®[AQ], Norditropin®, or Zomacton®) is medically necessary when all of the following are met:
- Growth velocity increased by at least 50 percent from baseline; and
- For Humatrope®, Genotropin®, Zomacton® only, inadequate response or inability to tolerate ONE of the following:
- Nutropin®/Nutropin AQ®; or
- Norditropin®; or
- Omnitrope®; and
- Yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
B. Turner Syndrome INITIAL CRITERIA Somatropin (Humatrope®, Genotropin®, Norditropin®, Nutropin®[AQ], Omnitrope® or Zomacton®) is medically necessary when all of the following are met:
- Diagnosis of Turner syndrome (Gonadal Dysgenesis); and
- Prescribed by an endocrinologist; and
- Height is below the 5th percentile on growth charts for age and gender; and
- For Humatrope®, Genotropin®, Zomacton® only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Nutropin®/Nutropin AQ®; or
- Omnitrope®
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Humatrope®, Genotropin®, Norditropin®, Nutropin®[AQ], Omnitrope® or Zomacton®) is medically necessary when all of the following are met:
- Growth velocity greater than or equal to 2.5 cm/year; and
- For Humatrope®, Genotropin®, Zomacton® only, inadequate response or inability to tolerate ONE of the following:
- Nutropin®/Nutropin AQ®; or
- Norditropin®; or
- Omnitrope®; and
- Yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
C. Growth Hormone deficiency in children
INITIAL CRITERIA: Somatropin (Omnitrope, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin® [AQ], Zomacton®) somapacitan-beco (Sogroya®), somatrogon-ghla (Ngenla®) or lonapegsomatropin-tcgd (Skytrofa™) is medically necessary when all of the following are met: - Prescribed by an endocrinologist; and
- Growth velocity less than or equal to 5 cm/year after 2 years of age; and
- Bone age determination documented; and
- Either ONE of the following responses from provocative testing:
- Abnormal response on insulin-induced hypoglycemia test (less than 5 ng/ml); or
- Abnormal response of less than 10 ng/ml to any other two provocative tests (performed sequentially, not simultaneously), such as but not limited to levodopa and clonidine; and
- For Genotropin®, Humatrope®, Saizen®, Zomacton®, somapacitan-beco (Sogroya®) only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Nutropin®/Nutropin AQ®; or
- Omnitrope®; and
- For somapacitan-beco (Sogroya®) only, inadequate response or inability to tolerate BOTH of the following:
- somatrogon-ghla (Ngenla®); and
- lonapegsomatropin-tcgd (Skytrofa™)
Initial authorization duration: 1 year
CONTINUATION CRITERIA: Somatropin (Omnitrope®, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin®[AQ], Zomacton®), somapacitan-beco (Sogroya®), somatrogon-ghla (Ngenla®) or lonapegsomatropin-tcgd (Skytrofa™) is medically necessary when all of the following are met: - Growth velocity greater than or equal to 2.5cm/year; and
- For Genotropin®, Humatrope®, Saizen®, Zomacton®, somapacitan-beco (Sogroya®) only, inadequate response or inability to tolerate ONE of the following:
- Nutropin®/Nutropin AQ®; or
- Norditropin®; or
- Omnitrope®; and
- For somapacitan-beco (Sogroya®) only, inadequate response or inability to tolerate BOTH of the following:
- somatrogon-ghla (Ngenla®); and
- lonapegsomatropin-tcgd (Skytrofa™); and
- Yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
D. Growth hormone deficiency in adults with adult-onset hypothalamic or pituitary disease OR Replacement of endogenous growth hormone (GH) deficiency
INITIAL CRITERIA: Somatropin (Omnitrope®, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin®[AQ], Zomacton®), somapacitan-beco (Sogroya®) is medically necessary when all of the following are met: - Prescribed by an endocrinologist; and
- Clinical history of adult-onset hypothalamic or pituitary disease of organic origin or known causes (e.g., damage from surgery, cranial irradiation, head trauma, or subarachnoid hemorrhage); and
- Deficiency in any two of the following:
- Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) (demonstrated by a low early morning serum testosterone concentration or a low serum estradiol concentration while FSH and LH concentrations are not elevated); or
- Thyroid-stimulating hormone (TSH) (demonstrated by a low serum T4 concentration and TSH concentration that is not elevated); or
- Adrenocorticotropic hormone (ACTH) (demonstrated by a low early morning serum cortisol and an ACTH that is not elevated); an
- GH response of less than 5 ng/ml to insulin-induced hypoglycemia; and
- For Genotropin®, Humatrope®, Saizen®, Zomacton®, Sogroya® only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Nutropin®/Nutropin AQ®; or
- Omnitrope®
Initial authorization duration: 1 year
CONTINUATION CRITERIA: Somatropin (Omnitrope®, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin®[AQ], Zomacton®), somapacitan-beco (Sogroya®) is medically necessary when all of the following are met: - For Genotropin®, Humatrope®, Saizen®, Zomacton®, Sogroya® only, inadequate response or inability to tolerate ONE of the following:
- Nutropin®/Nutropin AQ®; or
- Norditropin®; or
- Omnitrope®; and
- Yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
E. Growth Hormone deficiency in adults with childhood onset hypothalamic or pituitary disease INITIAL CRITERIA Somatropin (Omnitrope®, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin® [AQ] is medically necessary when all of the following are met: - Prescribed by an endocrinologist; and
- One of the following:
- Clinical history of organic or idiopathic panhypopituitarism as a child; and
- History of idiopathic, isolated GH deficiency in childhood requiring documentation of GH response of less than 5 ng/ml to Insulin-induced hypoglycemia
- For Genotropin®, Humatrope®, Saizen®, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Nutropin®/Nutropin® AQ; or
- Omnitrope®
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Omnitrope®, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin® [AQ] is medically necessary when all of the following are met: - For Genotropin®, Humatrope®, Saizen® only, inadequate response or inability to tolerate ONE of the following:
- Nutropin®/Nutropin® AQ; or
- Norditropin®; or
- Omnitrope®; and
- Yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
F. Dwarfism-Noonan syndrome INITIAL CRITERIA Somatropin (Norditropin®) is medically necessary when ALL of the following are met: - Diagnosis of Noonan syndrome; and
- Prescribed by an endocrinologist
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Norditropin®) is medically necessary when there is yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
G. Dwarfism short stature homeobox containing gene (SHOX) deficiency INITIAL CRITERIA Somatropin (Humatrope® or Zomacton®) is medically necessary when ALL of the following are met: - Diagnosis of short stature or growth failure in children with short stature homeobox containing gene (SHOX) deficiency; and
- Epiphyses are not closed; and
- Prescribed by an endocrinologist
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Humatrope® or Zomacton®) is medically necessary when there is yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
H. Small for gestational age INITIAL CRITERIA Somatropin (Humatrope®, Genotropin®, Norditropin®, Omnitrope®, or Zomacton®) is medically necessary when all of the following are met: - Failure to reach the third percentile for length/height by 2 years of age (Genotropin®, Omnitrope®) or 2 to 4 years of age (Norditropin®, Humatrope®); and
- Prescribed by an endocrinologist; and
- One of the following:
- Birth length and/or weight less than the third percentile for gestational age
- Birth weight less than 2500 grams and gestational age greater than 37 weeks
- For Humatrope®, Genotropin®, and Zomacton® only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Omnitrope®
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Humatrope®, Genotropin®, Norditropin®, Omnitrope®, or Zomacton®) is medically necessary when all of the following are met: - Growth velocity greater than or equal to 2.5cm/year; and
- For Humatrope®, Genotropin®, and Zomacton® only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Omnitrope: and
- Yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
I. Hypopituitarism in childhood
INITIAL CRITERIA Somatropin (Omnitrope®, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin® [AQ] is medically necessary when all of the following are met: - Clinical evidence of a pituitary lesion or midline central nervous system defect; and
- Prescribed by an endocrinologist; and
- Growth velocity less than or equal to 5 cm/year after 2 years of age; and
- Documentation of one of the following:
- Provocative testing, such as but not limited to the following:
- Levadopa
- Clonidine
- Insulin-induced hypoglycemia
- Deficiencies in two or more other hypothalamic-pituitary axes; and
- For Genotropin®, Humatrope®, Saizen® only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Nutropin®/Nutropin AQ®; or
- Omnitrope®
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Omnitrope®, Norditropin®, Genotropin®, Humatrope®, Saizen®, Nutropin® [AQ] is medically necessary when all of the following are met: - For Genotropin®, Humatrope®, Saizen® only, inadequate response or inability to tolerate ONE of the following:
- Nutropin®/Nutropin AQ®; or
- Norditropin®; or
- Omnitrope®; and
- Yearly evaluation by an endocrinologist
Continuation authorization duration: 1 year
J. Prader-Willi syndrome INITIAL CRITERIA Somatropin (Omnitrope®, Genotropin®, or Norditropin®) is medically necessary when all of the following are met: - Diagnosis of Prader-Willi syndrome; and
- Prescribed by an endocrinologist; and
- For Genotropin® only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Omnitrope®
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Omnitrope®, Genotropin®, or Norditropin®) is medically necessary when BOTH of the following are met: - Yearly evaluation by an endocrinologist; and
- For Genotropin® only, inadequate response or inability to tolerate ONE of the following:
- Norditropin®; or
- Omnitrope®
Continuation authorization duration: 1 year
K. Chronic Kidney Disease (CKD) INITIAL CRITERIA Somatropin (Nutropin® [AQ]) is medically necessary when all of the following are met: - Diagnosis of growth failure associated with CKD; and
- Height below the third percentile on standardized growth charts; and
- Member is not a renal transplant recipient; and
- Prescribed by an endocrinologist or nephrologist
Initial authorization duration: 1 year
CONTINUATION CRITERIA Somatropin (Nutropin® [AQ]) is medically necessary when all of the following are met: - No documentation of a renal transplant; and
- Yearly evaluation by an endocrinologist or nephrologist; and
- Growth velocity greater than or equal to 2.5 cm/year
Continuation authorization duration: 1 year
L. Short bowel syndrome INITIAL CRITERIA Somatropin (Zorbtive®) is medically necessary when all of the following are met: - Diagnosis of short bowel syndrome; and
- Member is currently receiving specialized nutritional support (e.g., intravenous parenteral nutrition, fluid, and micronutrient supplements); and
- Member has not previously received 4 weeks of treatment with Zorbtive
Authorization duration: 6 weeks
M. AIDS wasting syndrome INITIAL CRITERIA Somatropin (Serostim®) is medically necessary when all of the following are met: - Diagnosis of wasting (cachexia) associated with HIV; and
- Concomitant antiretroviral therapy that has been optimized to decrease the viral load; and
- Current weight less than 90 percent of ideal body weight; and
- Nutritional evaluation since onset of wasting first occurred
Initial authorization duration: 12 weeks
CONTINUATION CRITERIA Somatropin (Serostim®) is medically necessary when there is documentation of positive response to therapy (i.e., greater than or equal to 2% increase in body weight and/or body cell mass)
Continuation authorization duration: 36 weeks (for 48 weeks of total treatment)
| | | Genotropin® (somatoropin) [package insert]. New York, NY. Pharmacia and Upjohn Company. April 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ffebf88b-d257-4542-9808-74d9b7167765&type=display. Accessed October 14, 2024. Humatrope® (somatoropin) [package insert]. Indianapolis, IN. Eli Lilly and Company. December 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a774e1ae-3997-49ee-8b0e-99a2b315d409&type=display. Accessed October 14, 2024. Ngenla (somatrogon-ghla) [prescribing information. New York, NY: Pfizer Labs. June 2023. Available at: labeling.pfizer.com/ShowLabeling.aspx?id=19642. Accessed October 14, 2024. Norditropin® (somatoropin) [package insert]. Plainsboro, NJ. Novo Nordisk. March 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1058e17c-9261-459c-a3e6-fae38d196c14&type=display. Accessed October 14, 2024. Nutropin® AQ (somatoropin) [package insert]. San Francisco, CA. Genentech, Inc. December 2016. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=139d2038-e6a9-4ab1-ab00-aa7d8aa8df5f&type=display. Accessed October 14, 2024. Omnitrope® (somatoropin) [package insert]. Princeton, NJ. Novartis. June 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=58d84ffa-4056-4e36-ad67-7bd4aef444a5&type=display. Accessed October 14, 2024. Saizen® (somatoropin) [package insert]. Rockland, MA. EMD Serono, Inc. February 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ab750de2-3eda-411a-924e-00c499eda39b&type=display. Accessed October 14, 2024. Serostim® (somatoropin) [package insert]. Rockland, MA. EMD Serono, Inc. June 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=62b01d29-90f0-45b2-a0c4-3a750ba36c8a&type=display. Accessed October 14, 2024. Sogroya® (somapacitan-beco) [package insert]. Plainsboro, NJ. Novo Nordisk Inc. April 2023. Available at: https://www.novo-pi.com/sogroya.pdf. Accessed October 14, 2024. Skytrofa® (lonapegsomatropin-tcgd) [package insert]. Princeton, NJ. Ascendis Pharma Endocrinology, Inc.; October 2022. Available at: https://ascendispharma.us/products/pi/skytrofa/skytrofa_pi.pdf. Accessed October 14, 2024. Zomacton® (somatoropin) [package insert]. Parsippany, NJ. Ferring Pharmaceuticals Inc. April 2024. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886&type=display. Accessed October 14, 2024. Zorbtive® (somatoropin) [package insert]. Rockland, MA. EMD Serono, Inc. November 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c04b1b2c-5484-4a5d-887a-3f7ace8388a1&type=display. Accessed October 14, 2024.
| 20 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:14 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Genotropin® | Somatropin | | Humatrope® | Somatropin | | Norditropin® | Somatropin | | Nutropin®/Nutropin® AQ | Somatropin | | Omnitrope® | Somatropin | | Saizen® | Somatropin | | Serostim® | Somatropin | | Zomacton® | Somatropin | | Zorbtive® | Somatropin | | Skytrofa® | Lonapegsomatropin-tcgd | | Sogroya® | Somapacitan-beco | | Ngenla® | Somatrogon-ghla
|
| Growth Hormones | Growth Hormones | | 500 | | | 1/1/2025 | Rx.01.250 | Commercial | VanHorn, Lynnsey | Q3-2024 | Tyrosine is an aromatic amino acid important in the synthesis of thyroid hormones, catecholamines, and melanin. Impaired catabolism of tyrosine is a feature of several acquired and genetic disorders that may result in elevated plasma tyrosine concentrations. Tyrosinemia is a genetic disorder characterized by disruptions in the break down of the amino acid tyrosine, a building block of most proteins. If untreated, tyrosine and its byproducts build up in tissues and organs. Hereditary tyrosinemia type 1 (HT1; MIM# 276700), also known as hepatorenal tyrosinemia, is the most severe disorder of tyrosine metabolism. Nitisinone (Nityr®, Orfadin®) is a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of fumarylacetoacetate hydrolase (FAH) in the tyrosine catabolic pathway. By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the catabolic intermediates maleylacetoacetate and fumarylacetoacetate. In patients with HT-1, these catabolic intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate, which are responsible for the observed liver and kidney toxicity. Succinylacetone can also inhibit the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate, a neurotoxin responsible for the porphyric crises characteristic of HT-1.
| The intent of this policy is to communicate the medical necessity criteria for Nitisinone (Nityr®, Orfadin®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Nitisinone (Nityr®, Orfadin®) is medically necessary when all of the following are met: - Diagnosis of hereditary tyrosinemia type 1; and
- Will be used in combination with dietary restriction of tyrosine and phenylalanine; and
- Diagnosis confirmed by the presence of succinylacetone in the plasma or urine; and
- Prescribed by or in consultation with one of the following:
- Gastroenterologist
- Hepatologist
- Other specialist with experience in treating inborn errors of metabolism; and
- For Nitisinone (Nityr®) only, inadequate response or inability to tolerate Orfadin®
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA Nitisinone (Nityr®, Orfadin®) is medically necessary when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
| | | Nityr® (nitisinone) [package insert] Cambridge, UK: Cycle Pharmaceuticals Ltd. October 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209449s000lbl.pdf. Accessed October 14, 2024. Orfadin® (nitsinone) [package insert] Stockholm, Sweden: Swedish Orphan Biovitrum. November 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206356s000lbl.pdf. Accessed October 14, 2024. Tyrosinemia: MedlinePlus Genetics. Medlineplus.gov. Available from: https://medlineplus.gov/genetics/condition/tyrosinemia/. Accessed October 14, 2024. Grompe M. Disorders of tyrosine metabolism. UpToDate. November 2020. Available at: https://www.uptodate.com/contents/disorders-of-tyrosine metabolism?search=orfadin&source=search_result&selectedTitle=2~3&usage_type=default&display_rank=1. Accessed October 14, 2024.
| 4 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:14 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Nityr®, Orfadin® | Nitisinone |
| Nityr® and Orfadin® | Nitisinone | | 501 | | | 1/1/2025 | Rx.01.169 | Commercial | VanHorn, Lynnsey | Q3-2024 | Insulin stimulates peripheral glucose uptake by inhibiting hepatic glucose production and glucose uptake by skeletal muscle and fat.
Afrezza® is a rapid-acting insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
| The intent of this policy is to communicate the medical necessity criteria for insulin human, inhalation (Afrezza®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Afrezza® is medically necessary when ALL of the following are met: - Member is 18 years of age or older; and
- One of the following:
- Both of the following:
- Diagnosis of type I diabetes mellitus; and
- Used in combination with a long-acting insulin (e.g., Lantus)
- Diagnosis of type II diabetes mellitus; and
Spirometry (FEV1) completed prior to initiation of therapy to identify potential lung disease (must provide the result); and Member is a non-smoker for a minimum of 6 months; and Absence of chronic lung disease such as asthma or chronic obstructive pulmonary disease; and Prescribed by or in consultation with an endocrinologist
Initial authorization duration: 6 months REAUTHORIZATION CRITERA: Afrezza® is medically necessary when the following are met: - There is documentation of spirometry value (FEV1) has not declined ≥ 20% from baseline; and
- There is documentation of positive clinical response to therapy
Reauthorization duration: 2 years
| WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza®. Afrezza® is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating Afrezza®, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
| | Afrezza® (insulin human, inhalation) [package insert].Bridgewater, NJ: Sanofi-aventis US LLC. February 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=29f4637b-e204-425b-b89c-7238008d8c10&type=display. Accessed October 10, 2024.
Insulin human inhalation. Micromedex. Available from: http://www.micromedexsolutions.com. Accessed October 10, 2024.
| 11 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:14 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Afrezza® | Insulin human, inhalation |
| Afrezza® | Insulin human | | 502 | | | 1/1/2025 | Rx.01.270 | Commercial | VanHorn, Lynnsey | Q3-2024 | Type 1 diabetes mellitus (T1DM) is characterized by absolute insulin deficiency due to autoimmune βcell destruction. Insulin is the mainstay of therapy for T1DM. Childhood type 1 diabetes mellitus can present with chronic polydipsia, polyuria, weight loss with hyperglycemia and ketonemia or ketonuria, diabetic ketoacidosis or asymptomatic incidental discovery.
Type 2 diabetes mellitus (T2DM) is characterized by insulin resistance and usually relative (rather than absolute) insulin deficiency. Patients with T2DM may have insulin levels that appear normal or elevated. However, the higher blood glucose levels in these patients would be expected to result in even higher insulin values with normally functioning beta cells. Hence, insulin secretion is defective and insufficient to compensate for insulin resistance. Adults with type 2 diabetes are at risk for obesity, hypertension, dyslipidemia, fatty liver disease, sleep apnea, as well as periodontal disease.
Insulin and its analogs lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis. Insulin, secreted by the beta cells of the pancreas, is the principal hormone required for proper glucose use in normal metabolic processes.
| The intent of this policy is to communicate the medical necessity criteria for Humalog TMPO®, Lyumjev TMPO®, Novolog Relion or Novolin Relion, Insulin aspart, Basaglar TMPO®, Levemir®, Tresiba® (insulin degludec), Insulin glargine, and Semglee® (insulin glargine-YFGN) as provided under the member's prescription drug benefit.
| Humalog TMPO®, Lyumjev TMPO®, Novolog Relion, Novolin Relion or Insulin aspart is medically necessary when ALL of the following are met: - Diagnosis of diabetes mellitus; and
- Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
- Novolin®
- Novolog®
- Humalog®/Insulin lispro
- Lyumjev®
- Fiasp®
- Apidra®
- Admelog®
- Humulin®
Authorization duration: 2 years
Basaglar TMPO®, Levemir®, Tresiba®, Insulin Degludec, Insulin glargine-YFGN/Semglee®, or Insulin Glargine is medically necessary when ALL of the following are met: - Diagnosis of diabetes mellitus; and
- Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate THREE of the following:
- Lantus®
- Toujeo®
- Basaglar®
- Rezvoglar®
Authorization duration: 2 years
| | | American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2018; 41 (suppl 1): S13-S27. DOI: 10.2337/dc18-S002.
American Diabetes Association. Pharmacologic approaches to glycemic treatment. Diabetes Care. 2018;41 (suppl 1): S73-S85. DOI: 10.2337/dc18-S008.
Levitsky LL, Misra M. Epidemiology, presentation, and diagnosis of type 1 diabetes mellitus in children and adolescents. UpToDate website. January 2023. Available at: http://www.uptodate.com/. Accessed October 10, 2024.
Wexler Deborag. Overview of general medical care in nonpregnant adults with diabetes mellitus. UpToDate website. August 2024. Available at: http://www.uptodate.com/. Accessed October 10, 2024.
Basaglar TMPO® [package insert]. Indianapolis, IN 46285. Lilly USA, LLC. July 2021. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/2050692lbl.pdf. Accessed October 10, 2024.
Humalog TMPO® [package insert]. Indianapolis, IN 46285. Lilly USA LLC. November 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf . Accessed October 10, 2024.
Levemir® [package insert]. Denmark, Bagsvaerd 2880. Novo Nordisk A/S. 2019. Available from: https:///www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s054lbl.pdf . Accessed October 10, 2024.
Lyumjev TMPO® [package insert]. Indianapolis, IN 46285, USA. Eli Lilly and Company. October 2022. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761109s000lbl.pdf . Accessed October 10, 2024.
Semglee® [package insert]. Morgantown, WV 26505 U.S.A. Mylan Pharmaceutical Inc. July 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761201Orig1s000lbl.pdf . Accessed October 10, 2024.
Tresiba® [package insert]. Denmark, Bagsvaerd 2880. Novo Nordisk A/S. September 2015. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf . Accessed October 10, 2024.
| 6 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:15 AM | srv_ppsgw_P | Off-Label Use Policy Rx.01.33 Quantity level limits for pharmaceuticals covered under the prescription drug benefit Rx.01.76
| | Brand Name | Generic Name | | Basaglar TMPO® | Insulin Glargine | | Humalog TMPO® | Insulin Lispro | | Insulin aspart | | | Insulin glargine | | | Levemir® | Insulin Detemir | | Lyumjev TMPO® | Insulin Lispro-aabc | | Novolin® Relion | Insulin Regular | | Novolog® Relion | Insulin aspart | | Semglee® | Insulin Glargine-yfgn | | Tresiba® | Insulin Degludec | | Insulin Degludec | |
| Basaglar TMPO®, Humalog TMPO®, Insulin aspart, Insulin glargine, Levemir®, Lyumjev TMPO®, Novolin® Relion, Novolog® Relion, Insulin glargine-YFGN/Semglee®, Tresiba®, and Insulin Degludec | Insulin Glargine, Insulin Lispro, Insulin Detemir, Insulin Lispro-aabc, Insulin Regular, Insulin aspart, Insulin Glargine-yfgn, and Insulin Degludec | | 503 | | | 1/1/2025 | Rx.01.230 | Commercial | VanHorn, Lynnsey | Q3-2024 | Chronic Granulomatous Disease (CGD) is a disorder that causes the immune system to malfunction, resulting in immunodeficiency in patients. CGD is a genetically heterogeneous condition characterized by recurrent, life-threatening bacterial and fungal infections and granuloma formation. These defects result in the inability of phagocytes (neutrophils, monocytes, and macrophages) to destroy certain microbes. Patients with CGD are susceptible to infections from foreign invaders such as bacteria and fungi. Severe Malignant osteopetrosis is a disease where osteoclasts do not function the right way, and abnormal bone development occurs. This abnormal bone development can cause anemia, bleeding, and immunodeficiency. Interferons bind to specific cell surface receptors and initiate a sequence of intracellular events that lead to the transcription of interferon-stimulated genes. The three major groups of interferons (alpha, beta, gamma) have partially overlapping biological activities that include immunoregulation such as increased resistance to microbial pathogens and inhibition of cell proliferation. Type 1 interferons (alpha and beta) bind to the alpha/ beta receptor. Interferon gamma binds to a different cell surface receptor and is classified as Type 2 interferon. Specific effects of interferon gamma include the enhancement of the oxidative metabolism of macrophages, antibody dependent cellular cytotoxicity (ADCC), activation of natural killer (NK) cells, and the expression of Fc receptors and major histocompatibility antigens. Actimmune® is an interferon gamma indicated for reducing the frequency and severity of infections associated with Chronic Granulomatous Disease (CGD) and delaying the time to disease progression in patients with severe, malignant osteopetrosis.
| The intent of this policy is to communicate the medical necessity criteria for Interferon gamma-1b (Actimmune®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Interferon gamma-1b (Actimmune®) is medically necessary when ONE of the following is met: - Diagnosis of chronic granulomatous disease (CGD); or
- Diagnosis of severe, malignant osteopetrosis (SMO)
Initial authorization duration: 2 years REAUTHORIZATION CRITERIA: Interferon gamma-1b (Actimmune®) is medically necessary when there is documentation of positive clinical response to therapy (i.e., delay of malignant osteopetrosis disease progression; reduction in the frequency and severity of serious infections associated with Chronic Granulomatous Disease)
Reauthorization duration: 2 years
| | | Actimmune® (interferon gamma) [package insert]. Rosewell, GA; HZNP Inc.: March 2021. Available from: https://www.hzndocs.com/ACTIMMUNE-Prescribing-Information.pdf. Accessed October 10, 2024.
Chronic granulomatous disease. US National Library of Medicine website. Accessed October 10, 2024 Medlineplus.gov/genetics/condition/chronic-granulomatous-disease/#:~:text=Chroninc%20granulomatous%20disease%20is%20a,such%20bacteria%20and%20fungi.
| 5 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:15 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.221 Drugs Exceeding Claim Dollar Limit Threshold
| | Brand Name | Generic Name | Actimmune®
| Interferon gamma-1b |
| Actimmune® | Interferon gamma-1b | | 504 | | | 1/1/2025 | Rx.01.54 | Commercial | VanHorn, Lynnsey | Q3-2024 | Mecasermin (Increlex®) is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Mecasermin is a recombinant form of human insulin-like growth factor I (rhIGF-I) that mediates anabolic and growth-promoting effects of growth hormone. Endogenous Insulin Growth Factor1 (IGF-1) is required for normal growth and brain development. IGF-1 is in part directed towards stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues. Mecasermin increases in insulin sensitivity by mimicking some actions of insulin. | The intent of this policy is to communicate the medical necessity criteria for mescasermin (Increlex®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Mecasermin (Increlex®) is medically necessary when all of the following are met: - Diagnosis of growth failure in children with ONE of the following:
- All of the following:
- Severe primary insulin-like growth factor-1 deficiency (IGF-D); and
- Height standard deviation (SD) score of less than or equal to 3.0 SD scores below normal (growing at below the third percentile for age and sex); and
- Baseline IGF-1 (SD) score of less than or equal to 3.0 SD scores below normal (based on age- and sex-related reference ranges); and
- Normal or elevated GH level (based on GH stimulation testing); or
- Both of the following:
- Growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH; and
- Measured titers of GH-neutralizing antibodies; and
- Member is 2 years of age or older; and
- Open epiphyses (bone growth plates) (bone age less than 14 years for girls and less than 16 years for boys); and
- Prescribed by or in consultation with an endocrinologist
Initial Authorization duration: 12 months CONTINUATION CRITERIA: Continuation of mecasermin (Increlex®) is medically necessary when all of the following are met: - Growth velocity greater than or equal to 2 cm/year; and
- Yearly evaluation by an endocrinologist; and
- BOTH of the following
- Expected adult height is not obtained; and
- Documentation of expected adult height goal
Continuation duration: 12 months
| | | Increlex® (mecasermin) [prescribing information]. Basking Ridge, NJ. Ipsen Biopharmaceuticals, Inc. March 2024. Available online at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a8b27a1b-a611-4f91-ad22-76d4b390c3ae&type=display#section-10.1. Accessed on October 10, 2024.
Mecasermin. Micromedex Solutions [Internet database]. Available at: www.micromedexsolutions.com. Accessed October 10, 2024.
| 14 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:15 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Increlex® | mecasermin |
| Increlex® | mecasermin | | 505 | | | 1/1/2025 | Rx.01.157 | Commercial | VanHorn, Lynnsey | Q3-2024 | Generalized lipodystrophy is a disorder characterized by the absence or diffuse deficiency of adipose tissue, resulting in deficiency of the hormone, leptin. Leptin is important for appetite suppression, and deficiency results in uncontrolled intake of calories and subsequent deposit in areas such as the liver or muscle. Patients with generalized lipodystrophy often develop metabolic disorders such as insulin resistance and/or elevation in serum triglycerides.
Metreleptin is a recombinant human leptin analog that binds to and activates the human leptin receptor (ObR), which belongs to the class I cytokine family of receptors that signals through the JAK/STAT transduction pathway. Activation of the leptin receptor by metreleptin mimics native leptin, which is responsible for signaling the CNS with the status of energy stores in the body.
Metreleptin (Myalept®) is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
| The intent of this policy is to communicate the medical necessity criteria for metreleptin (Myalept®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Metreleptin (Myalept®) is medically necessary when ALL of the following are met: - Diagnosis of congenital or acquired generalized lipodystrophy (excluding other forms of lipodystrophy); and
- Prescribed as adjunct to diet as replacement therapy; and
- Member is refractory to current standards of care for lipid and diabetic management; and
- Prescribed by or in consultation with an endocrinologist; and
- Documentation demonstrates that member has at least one of the following metabolic abnormalities:
- Insulin resistance (defined as requiring more than 200 units per day)
- Hypertriglyceridemia
- Diabetes
Initial Authorization duration: 12 months
CONTINUATION CRITERIA: Continuation of metreleptin (Myalept®) is medically necessary when there is documentation of positive clinical response to metreleptin (Myalept®) therapy (e.g., sustained reduction in Hemoglobin A1c or triglycerides from baseline)
Continuation authorization duration: 2 years
| WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with metreleptin. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of metreleptin efficacy. Severe infection and/or worsening metabolic control have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of metreleptin efficacy during treatment.
T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with metreleptin. Carefully consider the benefits and risks of treatment with metreleptin in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy.
Because of these risks associated with the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or metreleptin and the risk for lymphoma, metreleptin is available only through a restricted risk evaluation and mitigation strategy (REMS) program. | | Metreleptin. Micromedex Solutions [database on the Internet]. Available at: www.micromedexsolutions.com. Accessed October 10, 2024.
Myalept® (metreleptin) [prescribing information]. Cambridge, MA. Aegerion Pharmaceuticlas, Inc. February 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c986f93b-855d-4ef0-b620-5d41a0513e48&type=display. Accessed October 10, 2024.
Mantzoros, MD. Lipodystrophic syndromes Post TW, ed. October 10, 2024.
| 11 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:15 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Myalept® | metreleptin |
| Myalept® | metreleptin | | 506 | | | 1/1/2025 | Rx.01.193 | Commercial | VanHorn, Lynnsey | Q3-2024 | The Company utilizes a tiered cost-sharing structure for medications covered under the pharmacy benefit. Members should refer to their benefit booklet for more information.
Formulary Tier Exceptions The following tier exceptions requests will be considered:
A. Select Drug Formulary Non-preferred drug to be covered at the: - Preferred brand tier if the product is a brand medication; or
- Generic tier if the product is generic medication
All other tiers are restricted to the benefit design and thus are not eligible for a tier exception B. Value Formulary Non-formulary medication to be covered at the highest level of cost share. These exceptions are not eligible for tier reduction. Non-preferred drug to be covered at the: - Preferred brand tier if the product is a brand medication; or
- Generic tier if the product is generic medication
All other tiers are restricted to the benefit design and thus are not eligible for a tier exception. The following tiers are defined by the benefit and are not eligible for a tier exception: - Specialty tier
- Preferred brand tier
- Generic tier
Definitions: - Biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product. A biosimilar may be used in patients who have previously been treated with the reference product (treatment-experienced), as well as in patients who have not previously received the reference product (treatment-naïve).
- Generic Equivalence is a term used for the generic drug which is created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine.
- Formulary alternative is a formulary covered drug alternative in the same pharmacological class as the requested drug.
Cost Share Exceptions for Preventive Care Services The services listed in this policy are considered preventive care services when the criteria in this policy are met, when they are identified as preventive services in the Company's benefit contracts and when they are mandated by state or federal law. This policy supports the preventative care services listed in the US Preventive Services Task Force (USPSTF) as A or B Recommendations. These products are available without cost-sharing with a prescription when provided by a participating retail or mail-order pharmacy. Based on the USPSTF recommendation the following products are available at zero-dollar cost-share. All medications refer to generic, single ingredient products unless otherwise noted. | Category | Recommendation | Medication | | ASPIRIN | Pregnant Women Who Are At High Risk for Preeclampsia: The USPSTF recommends the use of low-dose aspirin (81 mg/d) as preventive medication after 12 weeks of gestation in pregnant females who are at high risk for preeclampsia. | aspirin 81mg or less | | TOBACCO CESSATION MEDICATION | Tobacco cessation medication is covered as a preventive service for all adults who use tobacco products. | Chantix ®, bupropion, Nicotrol®, generic nicotine gums and patches | | FOLIC ACID | The USPSTF recommends that all females planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid. | folic acid 400 mcg to 800 mcg (including generic prenatal vitamins with the above listed folic acid dose) | | FLUORIDE | In accordance with the preventive exam age schedule set forth by American Academy of Pediatrics (AAP)/Bright Futures, oral fluoride, up to 0.5mg, is covered as a preventive service for children ages 6 months to 16 years whose water supply is deficient in fluoride. | fluoride up to 0.5mg for children 6 months to 16 years of age | | BREAST CANCER CHEMO-PREVENTION | The USPSTF recommends that clinicians engage in shared, informed decision making with individuals who are at increased risk for breast cancer about medications to reduce their risk. For asymptomatic females 35 years or older without a prior diagnosis of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ, who are at increased risk for breast cancer and at low risk for adverse medication effects from breast cancer chemoprevention, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen. | tamoxifen 20mg | | BOWEL PREP FOR COLONOSCOPY | The USPSTF recommends screening for colorectal cancer starting at age 45 years and continuing until age 75 years. | PEG 3350- electrolyte, Gavilyte-C, Gavilyte-G, Gavilyte-N, PEG-prep, PEG 3350 powder for solution | | STATIN PREVENTIVE MEDICATION | The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (i.e., dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year risk of a cardiovascular event of 10% or greater. | lovastatin 10, 20, 40 mg | | HIV PrEP | Preexposure prophylaxis (PrEP) with effective antiretroviral therapy for persons who are at high risk of HIV acquisition | emtricitabine/tenofovir disoproxil fumarate 200mg-300mg, tenofovir 300mg
Descovy 200mg/25mg
|
Certain medications have additional indications that are not addressed by the preventative care measure, such as raloxifene, or have formulary alternatives. Thus, the plan employs medical management to administer the requirements. The policy below outlines the process by which an exception can be obtained for medications that may apply to the USPSTF recommendation but are not coded as $0 at the point-of-sale.
Refer to Contraceptives Formulary Exception policy for contraceptives coverage criteria.
| The intent of this policy is to communicate the medical necessity criteria for formulary exception requests as provided under the member's prescription drug benefit.
| Tier Exceptions: A non-preferred drug will be covered at the preferred tier for brand medications as listed below when there is documentation of inadequate response or inability to tolerate at least three preferred or generic tier alternatives in the same pharmacological class*. Reasonably equivalent therapeutic class alternatives will be considered when there are limited pharmacological class alternatives available. - Brand medication to preferred brand tier or
- Generic medication to generic tier
Non-formulary Exceptions: A non-formulary drug is medically necessary when ONE of the following are met: - $0 cost-share will apply when BOTH of the following are met:
- The drug is described as either a preventative medication identified by the US Preventive Services Task Force (USPSTF) or Women's Preventive Services provision of the Patient Protection and Affordable Care Act (PPACA); and if applicable; and
- For branded products, ALL of the following:
- Inadequate response or inability to tolerate the generic equivalent, if available; and
- Inadequate response or inability to tolerate a formulary alternative; and
- The prescriber has provided documentation indicating the requested product is medically necessary; or
- Appropriate level of cost share will apply when BOTH of the following are met:
- FDA approved, or compendia supported use; and
- ONE of the following:
- If biosimilar of the requested reference product or generic equivalent of the requested brand is available, both of the following:
- There is documentation of inadequate response or inability to tolerate biosimilar of the requested reference product or generic equivalent of the requested brand; and
- There is documentation of inadequate response or inability to tolerate at least two formulary alternatives in the same pharmacological class*. Reasonably equivalent therapeutic class alternatives will be considered when there are limited pharmacological class alternatives available. Safety edits (age and quantity limits) will apply to non-formulary requests; or
- If biosimilar of the requested reference product or generic equivalent of the requested brand is NOT available: there is documentation of inadequate response or inability to tolerate at least three formulary alternatives in the same pharmacological class*. Reasonably equivalent therapeutic class alternatives will be considered when there are limited pharmacological class alternatives available. Safety edits (age and quantity limits) will apply to non-formulary requests
Compounded ProductsA non-preferred compounded product may be covered at the preferred (formulary) tier when there is an inadequate response or inability to tolerate/use all other formulary alternatives.Note: Compounded products are specially made products to meet the needs of an individual member and are not considered generics and thus not eligible for an exception to the generic tier.
$0 Cost-Share Override An exception to allow no-cost share is medically necessary when: - The drug is described as either a preventative medication identified by the US Preventive Services Task Force (USPSTF) or Women's Preventive Services provision of the Patient Protection and Affordable Care Act (PPACA); and if applicable
- For branded products, ALL of the following:
- Inadequate response or inability to tolerate the generic equivalent, if available
- Inadequate response or inability to tolerate a formulary alternative
- The prescriber has provided documentation indicating the requested product is medically necessary
*If there are fewer than three alternatives, all alternatives in the pharmacological class must be considered. Authorization duration: 1 years
| Truvada® (emtricitabine and tenofovir disoproxil fumarate), tenofovir
Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued Truvada® and tenofovir. Hepatic function should be monitored closely in HBV-infected patients who discontinue Truvada® and tenofovir. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Truvada® (emtricitabine and tenofovir disoproxil fumarate)
Truvada® used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug resistant HIV-1 variants have been identified with the use of Truvada® for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate Truvada® for HIV-1 PrEP if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed.
| | Bright Futures Period Schedule. Available at: periodicity_schedule.pdf (aap.org). Accessed October 14, 2024 USPSTF A and B Recommendations by Date. US Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-a-and-b-recommendations Updated September 2022. Accessed October 14, 2024 Biosimilars - Overview for Health Care Professionals. August 1, 2024. Available at: Overview for Health Care Professionals | FDA. Accessed September 3, 2024. Generic Drugs: Questions and Answers. March 2021. Available at: Generic Drugs: Questions & Answers | FDA. Accessed October 14, 2024. Truvada® (emtricitabine and tenofovir disoproxil fumarate) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; June 2020. Available from: https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf. Accessed October 14, 2024 Viread® (tenofovir disoproxil fumarate) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; April 2019. Available from: https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/viread/viread_pi.pdf. Accessed October 14, 2024
| 18 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:15 AM | srv_ppsgw_P | Rx.01.33 Off Label Use
Rx.01.2 Applicable Age Edits
Rx.01.134 Compounded Product
Rx.01.76 Quantity Level Limits for Pharmaceutical Covered under the Pharmacy Benefit
Rx.01.197 Opioid Policy
Rx.01.291 Contraceptives Formulary Exception Policy
00.06.02 Preventive Care Services Medical Policy
| | New Jersey Formulary Exception Policy | New Jersey Formulary Exception Policy | | 507 | | | 1/1/2025 | Rx.01.231 | Commercial | VanHorn, Lynnsey | Q3-2024 | Acromegaly is a disease usually caused by a benign tumor on the pituitary gland, causing increased release of growth hormone. Increased release of growth hormone causes an increase in release of insulin-like growth factor I (IGF-I), causing the signs and symptoms of acromegaly.
Cutaneous flushing and diarrhea are commonly associated with carcinoid syndrome. Most flushing episodes primarily involves the face, neck, upper chest, which become red to violaceous or purple, and is associated with a mild burning sensation. Secretory diarrhea is often debilitating where stools may vary from few to more than 30 per day, are typically watery and non-bloody, can be explosive and accompanied by abdominal cramping. Diarrhea is usually unrelated to flushing episodes, though both can be minimized by pretreatment with octreotide.
Vasoactive intestinal peptide tumor (VIPoma) is suspected in patients with unexplained high-volume secretory diarrhea. Treatment of VIPoma starts with replacement of fluid losses and correction of electrolyte abnormalities. Somatostatin analogs inhibit the secretion of vasoactive intestinal polypeptide and are the treatment of choice to control diarrhea in VIPoma.
Octreotide exerts pharmacologic actions similar to the natural hormone somatostatin. It is a potent inhibitor of growth hormone, insulin like growth factor-1 (IGF-I), glucagon, and insulin. It suppresses luteinizing hormone response to gonadotropin releasing hormone. Since it releases growth hormone and IGF-I levels, it is beneficial in patients with acromegaly.
Octreotide acetate pen is indicated for: - Reduction of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adult patients with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
- Treatment of severe diarrhea/flushing episodes associated with metastatic carcinoid tumors in adult patients.
- Treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) in adult patients.
Mycapssa™ (octreotide) is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
| The intent of this policy is to communicate the medical necessity criteria for octreotide acetate, and octreotide (Mycapssa®) as provided under the member's prescription drug benefit.
| ACROMEGALY INITIAL CRITERIA: Octreotide acetate or octreotide (Mycapssa™) is medically necessary when ALL the following are met: - Member is 18 years of age or older; and
- Diagnosis of acromegaly; and
- Prescribed by or in conjunction with an endocrinologist; and
- One of the following:
- Inadequate response to surgery or pituitary irradiation; or
- Not a candidate for surgical resection or pituitary irradiation; and
- Inadequate response or inability to tolerate a dopamine agonist (e.g., bromocriptine or cabergoline) at maximally tolerated doses; and
- For Mycapssa™ only, member has responded to and tolerated treatment with Octreotide or Lanreotide products (e.g., Somatulline Depot, Sandostatin, Sandostatin LAR depot).
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Octreotide aetate or octreotide (Mycapssa™) is medically necessary with documentation of positive clinical response to therapy (e.g., reduction or normalization of IFG-I or Growth Hormone level for same age and sex)
Reauthorization duration: 2 years
CARCINOID TUMORS, FOR SYMPTOMATIC TREATMENT OF DIARRHEA OR FLUSHING
INITIAL CRITERIA: Octreotide acetate is medically necessary when ALL the following are met: - Diagnosis of metastatic carcinoid tumor; and
- Member requires symptomatic treatment of severe diarrhea or flushing episodes; and
- Member is 18 years of age or older
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Octreotide acetate is medically necessary with documentation of an improvement in the number of diarrhea or flushing episodes.
Reauthorization duration: 2 years
VASOACTIVE INTESTINAL PEPTIDE TUMORS, FOR SYMPTOMATIC TREATMENT OF DIARRHEA
INITIAL CRITERIA: Octreotide acetate is medically necessary when ALL the following are met: - Diagnosis of vasoactive intestinal peptide tumor; and
- Member requires the treatment of profuse watery diarrhea, and
- Member is 18 years of age or older
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Octreotide acetate is medically necessary with documentation of an improvement in the number of diarrhea episodes.
Reauthorization duration: 2 years
| | | Strosberg, J. Clinical features of carcinoid syndrome. December 2023. UpToDate. Available from: https://www.uptodate.com/contents/clinical-features-of-carcinoid-syndrome?search=carcinoid%20tumor&topicRef=2622&source=see_link#H11. Accessed Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951.
Mycapssa® (octreotide) [prescribing information]. Scotland, UK: MW Encap Ltd.; August 2024. Available from: https://label.mycapssa.com/wp-content/uploads/sites/4/2020/06/prescribinginformation.pdf. Accessed October 10, 2024. | 5 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:16 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Mycapssa | Octreotide |
| Mycapssa | Octreotide | | 510 | | | 1/1/2025 | Rx.01.210 | Commercial | VanHorn, Lynnsey | Q3-2024 | Phenylketonuria is a disorder affecting the aromatic amino acid, phenylalanine. It results from a deficiency of phenylalanine hydroxylase (PAH) and if untreated is characterized by intellectual disability.
Pegvaliase-pqpz (Palynziq™) is a PEGylated phenylalanine ammonia lyase (PAL) enzyme that converts phenylalanine to ammonia and trans-cinnamic acid. It substitutes for the deficient phenylalanine hydroxylase (PAH) enzyme activity in patients with PKU and reduces blood phenylalanine concentrations.
Pegvaliase-pqpz (Palynziq™) is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.
| The intent of this policy is to communicate the medical necessity criteria for Pegvaliase-pqpz (Palynziq™) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Pegvaliase-pqpz (Palynziq™) is medically necessary when ALL of the following are met: - Member is 18 years of age or older, and
- Member has diagnosis of phenylketonuria with uncontrolled blood phenylalanine concentration of greater than 600 micromol/L on existing management (e.g., medical foods, Kuvan®); and
- Member will continue to have phenylalanine blood levels measured every 4 weeks until a maintainance dose is established and periodically thereafter; and
- ONE of the following:
- Member has had an inadequate response or inability to tolerate the generic sapropterin; or
- Member is not a candidate for generic sapropterin therapy due to the presence of two null mutations in trans
Initial Authorization duration: 6 months
CONTINUATION CRITERIA: Pegvaliase-pqpz (Palynziq™) is medically necessary when there is documentation of a positive clinical response to Pegvaliase-pqpz (Palynziq™) therapy (i.e., reduction in blood phenylalanine concentrations).
Continuation authorization duration: 2 years
| WARNING: RISK OF ANAPHYLAXIS
See full prescribing information for complete boxed warning. - Anaphylaxis has been reported after administration of Palynziq and may occur at any time during treatment.
- Administer the initial dose of Palynziq under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self-injection, confirm patient competency with self-administration, and patient’s and observer’s (if applicable) ability to recognize signs and symptoms of anaphylaxis and to administer auto-injectable epinephrine, if needed.
- Prescribe auto-injectable epinephrine. Prior to first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry auto-injectable epinephrine with them at all times during Palynziq treatment.
- Palynziq is available only through a restricted program called the Palynziq REMS.
| | | 7 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:16 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Palynziq™ | Pegvaliase-pqpz |
| Palynziq™ | Pegvaliase-pqpz | | 511 | | | 1/1/2025 | Rx.01.232 | Commercial | VanHorn, Lynnsey | Q3-2024 | Acromegaly is a disease usually caused by a benign tumor on the pituitary gland, causing increased release of growth hormone (GH). Increased release of growth hormone causes an increase in release of insulin-like growth factor I (IGF-I), causing the signs and symptoms of acromegaly. Excess GH and IGF-1 have both somatic and metabolic effects. The somatic effects include stimulation of growth of many tissues, such as skin, connective tissue, cartilage, bone, viscera, and many epithelial tissues. The metabolic effects include nitrogen retention, insulin antagonism, and lipolysis.
Pegvisomant (Somavert®) is an analog of human growth hormone that has been structurally altered to act as a growth hormone antagonist. It blocks the binding of endogenous growth hormone, interfering with growth hormone signal transduction, causing a decreased serum concentration of IGF-I.
Pegvisomant (Somavert®) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels. | The intent of this policy is to communicate the medical necessity criteria for Pegvisomant (Somavert®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Pegvisomant (Somavert®) is medically necessary when ALL the following are met: - Diagnosis of acromegaly; and
- One of the following:
- Inadequate response to surgery or pituitary irradiation; or
- Not a candidate for surgical resection or pituitary irradiation; and
- Inadequate response or inability to tolerate a dopamine agonist (e.g., bromocriptine or cabergoline) at maximally tolerated doses; and
- Prescribed by or in consultation with an endocrinologist; and
- Member is 18 years of age or older
Initial authorization duration: 12 months
REAUTHORIZATION CRITERA: Pegvisomant (Somavert®) is medically necessary when there is documentation of positive clinical response to Somavert® therapy (i.e., reduction or normalization of IGF-1)
Reauthorization duration: 2 years
| | | Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951. Melmed, S. Causes and clinical manifestations of acromegaly. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Accessed October 14, 2024 Somavert® (pegvisomant) for injection [prescribing information]. New York, NY: Pfizer Inc.; July 2023. Available from: labeling.pfizer.com/ShowLabeling.aspx?id=3213. Accessed October 14, 2024.
| 5 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:16 AM | srv_ppsgw_P | Rx.01.33 Off Label Use
Rx.01.221 Drugs Exceeding Claim Dollar Limit Threshold | | Brand Name | Generic Name | | Somavert® | Pegvisomant
|
| Somavert® | Pegvisomant | | 512 | | | 1/1/2025 | Rx.01.190 | Commercial | VanHorn, Lynnsey | Q3-2024 | Pheochromocytomas are rare catecholamine secreting tumors, usually located within the adrenal glands, which may result in life-threatening hypertension or arrhythmias. Pheochromocytomas reportedly occur in 0.05-0.2% of hypertensive individuals. This is likely an underestimate, since some patients are asymptomatic. Approximately 10% of pheochromocytomas are discovered incidentally and 50% had diagnosis made on autopsy. Unlike catecholamine release from healthy adrenal tissue, catecholamine release from pheochromocytomas is not regulated and the triggers for their release are unclear. Additionally, most pheochromocytomas predominantly release norepinephrine compared to predominantly epinephrine release from healthy adrenal tissue. Surgical resection is the treatment of choice, usually resulting in cure of the hypertension. Medical therapy is used preoperatively, for hypertensive crises, and as primary therapy for individuals with metastatic pheochromacytomas. Alpha adrenergic blockade is the cornerstone of pharmacologic therapy for pheochromocytomas. In the perioperative setting, phenoxybenzamine is initiated 10-14 days prior to surgery, in conjunction with volume expansion. Beta blockade is initiated only after adequate alpha blockade has been achieved. Selective alpha 1 blocking agents (doxazosin, terazosin, prazosin) may be used when long term therapy is required, but are not recommended for the preoperative management. Phenoxybenzamine is a long acting alpha adrenergic receptor antagonist, which produces and maintains a "chemical sympathectomy" when orally administered. Phenoxybenzamine (Dibenzyline®) is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating.
| The intent of this policy is to communicate the medical necessity criteria for phenoxybenzamine (Dibenzyline®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Phenoxybenzamine (Dibenzyline®) is medically necessary when ALL of the following are met:
- Diagnosis of pheochromocytoma; and
- Member is 18 years of age or older; and
- Prescribed by or in consultation with a nephrologist, endocrinologist or endocrine surgeon; and
- For brand Dibenzyline® only, inadequate response or inability to tolerate generic phenoxybenzamine; and
- Medication is being used for preoperative preparation; and
- Treatment will also include a high-sodium diet and fluid intake; and
- Inadequate response or inability to tolerate to one of the following
- Doxazosin; or
Terazosin; or Prazosin.
Initial Authorization duration: 6 months
REAUTHORIZATION CRITERIA: Phenoxybenzamine (Dibenzyline®) is medically necessary when both of the following are met: - Documentation of positive clinical response; and
- Yearly evaluation by prescriber for long-term use
Reauthorization duration: 12 months
| | | Blake MA. Pheochromocytoma. Available from:http://emedicine.medscape.com/article/124059-overview. Accessed October 09, 2024.
Dibenzyline® (phenoxybenzamine) [package insert]. St. Michael, Barbados. Concordia Pharmaceuticals. Dec 2018. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8852dd44-098c-4d99-88e0-a092a8e08e11&type=display. Accessed October 09, 2024.
Farrugia F, Martikos G, Tzanetis P, et al. Pheochromocytoma, diagnosis and treatment:
Review of the literature. Endocrine Regulations. 2017;51(3):168-181. Accessed October 09, 2024.
Lenders JWM, Duh Q-Y, Eisenhofer G, et al. Pheochromocytoma and Paraganglioma:
An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology
& Metabolism. 2014;99(6):1915-1942. Accessed October 09, 2024
| 9 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:16 AM | srv_ppsgw_P | | | Brand name | Generic name | | Dibenzyline® | phenoxybenzamine |
| Dibenzyline® | Phenoxybenzamine | | 513 | | | 1/1/2025 | Rx.01.234 | Commercial | VanHorn, Lynnsey | Q3-2024 | Phenylketonuria (PKU) is an inherited disorder that causes elevated blood levels of phenylalanine. PKU is caused by mutations of the PAH gene, which encodes for the enzyme phenylalanine hydroxylase. Phenylalanine hydroxylase converts phenylalanine to tyrosine. Patients with PKU cannot appropriately process phenylalanine from the diet, thus building up to potentially toxic levels in the blood. Excessive amounts of phenylalanine can cause brain and nerve damage if left untreated.
Kuvan®, Javygtor® (sapropterin dihydrochloride) is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria when used in combination with a low phenylalanine diet. | The intent of this policy is to communicate the medical necessity criteria for Kuvan®, Javygtor® (sapropterin dihydrochloride) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Sapropterin dihydrochloride (Kuvan®, Javygtor®) is medically necessary when ALL the following are met: - Diagnosis of phenylketonuria (PKU); and
- Used in conjunction with phenylalanine (Phe)-restricted diet; and
- Prescribed by or in consultation with a specialist with expertise in diagnosis and management of phenylketonuria; and
- For Brand Kuvan® and Javygtor® only: inadequate response or inability to tolerate generic sapropterin dihydrochloride; and
- Member will have Phe blood levels measured after 1 week of therapy (new starts to therapy only) and periodically for up to a month of therapy to determine response.
Initial authorization duration: 6 months
CONTINUATION CRITERIA: Sapropterin dihydrochloride (Kuvan®, Javygtor®) is medically necessary when ALL the following are met: - Member has had a positive clinical response to therapy (i.e. there is a reduction of phenylalanine (Phe) blood levels from baseline); and
- Used in conjunction with phenylalanine (Phe)-restricted diet
Reauthorization duration: 2 years
| | | Phenylketonuria. US National Library of Medicine website. Updated April 25, 2023. Medlineplus.gov/genetics/condition/phenylketonuria/#causes. Accessed October 09, 2024. Javygtor® (sapropterin dihydrochloride) [package insert]. Princeton, NJ: Dr. Reddy's Laboratories Inc.; January 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4. Accessed October 09, 2024. Kuvan® (sapropterin dihydrochloride) [package insert]. Novato, CA: BioMartin Pharmaceutical Inc.; February 2021. Available from: https://www.kuvan.com/hcp/wp-content/file/KUVAN_Prescribing_Information1.pdf. Accessed October 09, 2024.
| 5 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:17 AM | srv_ppsgw_P | Rx.01.33 Off Label Use Rx.01.221 Drugs Exceeding Claim Dollar Limit Threshold
| | Brand Name | Generic Name | Kuvan, Javygtor®
| Sapropterin dihydrochloride |
| Kuvan® and Javygtor® | Sapropterin dihydrochloride | | 514 | | | 1/1/2025 | Rx.01.244 | Commercial | VanHorn, Lynnsey | Q3-2024 | In a very small percentage of individuals, obesity may occur due to changes in a single gene. The most commonly implicated gene encodes melanocortin 4 (MC4) receptors (the MC4R gene).
Melanocortins are a family of melanocyte stimulating hormones (MSHs), some of which regulate hunger, caloric intake, energy expenditure, and bodyweight primarily thorough the MC4 receptor. Impairment in the MC4 receptor pathway leads to hyperphagia and early-onset severe obesity.
In normal physiology, leptin receptors (LEPRs) are expressed on proopiomelanocortin (POMC) neurons in the brain. The hormone leptin (from adipose tissue in the periphery) activates the LEPRs causing the POMC neurons to release MSH. The proprotein convertase subtilisin/kexin type 1 (PCSK1) gene codes for enzymes that also generate MSH from POMC-producing neurons. MSH binds to and activates MC4 receptors on MC4 receptor-expressing neurons. This binding stimulates a cascade of neurological signaling that ultimately leads to suppression of hunger, decreased food intake, and increased energy expenditure (FDA clinical review 2020, FDA summary review 2020).
Obesity due to POMC, PCSK1, or LEPR deficiency is due to variants in the POMC, PCSK1, or LEPR genes. These are very rare causes of obesity, with approximately 150 reported cases in medical literature for all three causes combined. A defect to one or more of these genes affects hunger levels, satiety, and energy output (metabolism). Individuals are usually a normal weight at birth but hyperphagia leads to progressive weight gain and early-onset obesity, which causes early-onset insulin resistance, hyperlipidemia, cardiovascular disease and other obesity-associated comorbidities. Patients with POMC, PCSK1, or LEPR deficiencies have progressive weight gain, which occurs at an average of 7 to 10 kg per year (Clement et al 2020, FDA press release 2020, FDA clinical review 2020).
Obesity in individuals can also be caused by Bardet-Biedl syndrome (BBS). BBS is an autosomal recessive disorder characterized by obesity and several other abnormalities, including microorchidism in men, intellectual disability, retinal dystrophy, polydactyly, renal malformations (particularly calyceal abnormalities), and polyuria and polydipsia. Mutations in at least 15 genes have been described in patients with this syndrome.
Setmelanotide (Imcivree™) is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS), and Bardet-Biedl syndrome (BBS).
Guidelines for general obesity have not yet been updated to include setmelanotide or treatment algorithms for genetic causes of obesity. There is no data to support traditional therapies for obesity would work in these patients such as FDA approved medications, bariatric surgery, or standard-of-care diet and exercise, since the cause of their obesity is genetic.
| The intent of this policy is to communicate the medical necessity criteria for Setmelanotide (Imcivree) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Setmelanotide (Imcivree™) is medically necessary when ALL of the following are met: - One of the following:
- Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), leptin receptor (LEPR) deficiency by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, or of uncertain significance (VUS); or
- Diagnosis of Bardet-Biedl syndrome; and
- Other causes or types of obesity have been ruled out (e.g., obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 or LEPR variants classified as benign or likely benign; obesity associated with other genetic syndromes; polygenic obesity; obesity due to Bardet-Biedl syndrome); and
- Member is obese as defined by BMI of ≥30kg/m2 in adults or ≥95th percentile in pediatric patients using growth chart assessments; and
- Prescribed by or in consultation with ONE of the following:
- Endocrinologist; or
- Medical geneticist; or
- Specialist in the diagnosis and treatment of obesity; and
- Member is 6 years of age or older
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA: Setmelanotide (Imcivree™) is medically necessary with documentation of positive clinical response to therapy (e.g. 5% weight loss based on baseline body weight or BMI) Reauthorization duration: 12 months
| | | Setmelanotide (Imcivree) [prescribing information]. Rhythm Pharmaceuticals, Inc. June 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213793s000lbl.pdf. Accessed October 14, 2024. Food and Drug Administration (FDA). Clinical Review: Imcivree. 2020. Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213793Orig1s000MedR.pdf. Accessed October 14, 2024. Clement K, van den Akker E, Argente J, et al. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicenter, phase 3 trials. Lancet Diabetes and Endocrinol. 2020;8(12):960-970. Perreault, L. Obesity: Genetic contribution and pathophysiology. In: UpToDate. Available from: https://www.uptodate.com/contents/obesity-genetic-contribution-and-pathophysiology?search=imcivree&source=search_result&selectedTitle=1~2&usage_type=default&display_rank=1#H2744130704. Accessed October 14, 2024.
| 4 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:17 AM | srv_ppsgw_P | | Brand Name
| Generic Name
| Imcivree
| Setmelanotide |
| Imcivree™ | Setmelanotide | | 515 | | | 1/1/2025 | Rx.01.206 | Commercial | VanHorn, Lynnsey | Q3-2024 | Sickle cell disease (SCD) is caused by a point mutation in the beta-globin gene, resulting in defective hemoglobin, which is less soluble than normal fetal or adult hemoglobin. The red blood cells become sickled in shape causing hemolytic anemia and vaso-occlusion, which can lead to acute and chronic pain, and tissue ischemia. SCD refers to any of the syndromes in which the sickle mutation is co-inherited with a mutation at the other beta globin allele that reduces normal beta globin production. It includes sickle cell anemia, sickle beta thalassemia, and hemoglobin sickle cell disease. Endari® is an amino acid indicated to reduce the acute complications of sickle cell disease in adults and pediatric patients 5 years of age and older. The mechanism of action of the amino acid L-glutamine in treating sickle cell disease (SCD) is not fully understood. Oxidative stress phenomena are involved in the pathophysiology of SCD. Sickle red blood cells (RBCs) are more susceptible to oxidative damage than normal RBCs, which may contribute to the chronic hemolysis and vaso-occlusive events associated with SCD. The pyridine nucleotides, NAD+ and its reduced form NADH, play roles in regulating and preventing oxidative damage in RBCs. L-glutamine may improve the NAD redox potential in sickle RBCs through increasing the availability of reduced glutathione. Voxelotor (Oxbryta®) is a hemoglobin S polymerization inhibitor that binds to HbS with a 1:1 stoichiometry and exhibits preferential partitioning to red blood cells (RBCs). By increasing the affinity of Hb for oxygen, voxelotor demonstrates dose-dependent inhibition of HbS polymerization. Nonclinical studies suggest that voxelotor may inhibit RBC sickling, improve RBC deformability, and reduce whole blood viscosity. Oxbryta® is indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older.
| The intent of this policy is to communicate the medical necessity criteria for L-glutamine (Endari®) and voxelotor (Oxbryta®) as provided under the member's prescription drug benefit.
| INITIAL CRITERIA L-glutamine (Endari®) is medically necessary when ALL of the following are met: - Diagnosis of sickle cell disease; and
- Member is 5 years of age or older; and
- Member has had 2 or more painful sickle cell crises within the past 12 months; and
- Prescribed by or in consultation with a hematologist/oncologist or specialist with expertise in the diagnosis and management of sickle cell disease, and
- Documentation of ONE of the following:
- Concurrent hydroxyurea therapy; or
- Inadequate response or inability to tolerate hydroxyurea
Initial authorization duration: 12 months
CONTINUATION CRITERIA L-glutamine (Endari®) is medically necessary when there is documentation of positive clinical response to therapy from baseline (e.g., reduction in the number of sickle cell crises, fewer hospitalizations due to sickle cell pain, etc.).
Continuation authorization duration: 2 years
INITIAL CRITERIA Voxelotor (Oxbryta®) is medically necessary when ALL of the following are met: - Diagnosis of sickle cell disease; and
- No concurrent therapy with crizanlizumab-tmca (Adakveo®); and
- Member is 4 years of age or older; and
- Member had at least one vaso-occlusive crisis (VOC) event within the past 12 months (e.g., acute painful crisis, acute chest syndrome); and
- Hemoglobin level that is between 5.5g/dL and 10.5g/dL prior to therapy initiation; and
- Inadequate response or inability to tolerate hydroxyurea (i.e. Siklos, Droxia); and
- Prescribed by or in consultation with a hematologist/oncologist or specialist with expertise in the diagnosis and management of sickle cell disease.
Initial authorization duration: 12 months CONTINUATION CRITERIA Voxelotor (Oxbryta®) is medically necessary when both of the following are met:
- Documentation of positive clinical response to Oxbryta® therapy (e.g., an increase in hemoglobin level of greater than or equal to 1 g/dL from baseline, decreased annualized incidence rate of VOCs); and
Member demonstrates hemoglobin level that does not exceed 10.5 g/dL
Continuation authorization duration: 2 years
| | | | 9 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:17 AM | srv_ppsgw_P | | Brand Name
| Generic Name
| | Endari® | L-glutamine | | Oxbryta® | Voxelotor |
| Endari® and Oxbryta® | L-glutamine and voxelotor | | 516 | | | 1/1/2025 | Rx.01.89 | Commercial | VanHorn, Lynnsey | Q3-2024 | Hyponatremia is defined as a relative excess of water in relation to sodium. Treatment approaches depend on the duration, severity, and cause of hyponatremia. Tolvaptan (Samsca®) is a selective vasopressin V2 receptor antagonist. Tolvaptan antagonizes the effect of vasopressin and causes an increase in urine water excretion that results in an increase in free water clearance, a decrease in urine osmolality and a resulting increase in serum sodium concentrations. Tolvaptan (Samsca®) is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium < 125meq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormone. Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by the growth of numerous fluid filled cysts in the kidneys which progressively decreases kidney function and lead to permanent kidney damage. It is the most common inherited disorder of the kidneys. Symptoms usually develop between the ages of 30 and 40, but they can begin earlier, even in childhood. Tolvaptan (Jynarque®) is a selective vasopressin (V2) receptor antagonist. Patients with autosomal dominant polycystic kidney disease have elevated levels of vasopressin. Tolvaptan works by preventing vasopressin from binding to its receptor which then decreases the rate of cell proliferation and fluid secretion into the cystic lumen, ultimately inhibiting the growth of the fluid filled cysts in the kidneys and slows the worsening of kidney function. Tolvaptan (Jynarque®) is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
| The intent of this policy is to communicate the medical necessity criteria for tolvaptan (Samsca®, Jynarque®) as provided under the member's prescription drug benefit.
| Hyponatremia INITIAL CRITERIA Tolvaptan (Samsca®) is medically necessary when ALL of the following are met: - Member is 18 years of age or older; and
- Clinically significant hypervolemic or euvolemic hyponatremia and ONE of the following:
- Serum sodium less than 125meq/L; or
- Serum sodium 125-134meq/L with symptoms (i.e., nausea, vomiting, headache, lethargy, confusion, etc.); and
- Inadequate response or inability to tolerate therapies to control hyponatremia (i.e., fluid restriction, diuretics, demeclocycline, etc.); and
- Prescribed by or in consultation with a cardiologist, nephrologist, or endocrinologist; and
- Brand Samsca only, inadequate response or inability to tolerate generic tolvaptan; and
- Treatment has been initiated or re-initiated in a hospital setting prior to discharge within the past 30 days
Initial authorization duration: 30 days REAUTHORIZATION CRITERIA Tolvaptan (Samsca®) is medically necessary when ALL of the following are met: - Documentation of positive clinical response; and
- Liver function is monitored and there are no signs or symptoms of liver injury; and
- Prescriber is aware of the risk of liver injury with use beyond 30 days
Reauthorization duration: 12 months
Autosomal dominant polycystic kidney disease INITIAL CRITERIA Tolvaptan (Jynarque®) is medically necessary when ALL of the following are met: - Member is 18 years of age or older; and
- Diagnosis of autosomal dominant polycystic kidney disease with risk of rapidly progressing kidney disease; and
- Baseline serum transaminases and bilirubin obtained prior to initiation of therapy; and
- Prescribed by or in consultation with nephrologist or kidney transplant specialist
Initial authorization duration: 3 months
REAUTHORIZATION CRITERIA Tolvaptan (Jynarque®) is medically necessary when ALL of the following are met: - ONE of the following
- Decline in kidney function has slowed; or
- Kidney pain has improved; and
- Serum transaminase less than 3 times the upper limit of normal; and
- Bilirubin less than 2 times upper limit of normal
Reauthorization duration: 12 months
| Tolvaptan (Samsca®)
INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM
Tolvaptan (Samsca®) should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely.
Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.
Tolvaptan (Jynarque®) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported.
Measure ALT, AST and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months and every 3 months or symptoms indicative of hepatic injury can mitigate, but not eliminate, the risk of serious hepatotoxicity.
Because of the risks of serious liver injury, Jynarque® is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the JYNARQUE REMS Program
| | Jynarque® (tolvaptan) [package insert] Tokyo, Japan. Otsuka Pharmaceutical Co, Ltd. -October 2020. Available at: https://www.otsuka-us.com/media/static/JYNARQUE-PI.pdf. Accessed - October 09, 2024.
Samsca® (tolvaptan) [package insert]. Tokyo, Japan. Otsuka Pharmaceutical Co, Ltd. -April 2021. Available at:https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5526617c-c7b9-4556-886d-729bbabbc566&type=display. Accessed October 09, 2024.
Sterns RH. Overview of the treatment of hyponatremia in adults. UpToDate. June 2021. Available at: https://www.uptodate.com/contents/overview-of-the-treatment-of-hyponatremia-in-adults?source=search_result&search=hyponatremia&selectedTitle=2~150#H25. Accessed October 09, 2024.
Tolvaptan (Kidney Disease): MedlinePlus Drug Information." MedlinePlus, U.S. National Library of Medicine, 15 July 2018, medlineplus.gov/druginfo/meds/a609033.html. Accessed October 09, 2024.
| 15 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:17 AM | srv_ppsgw_P | Off-Label Use Policy Rx.01.33
| | Brand Name | Generic Name | | Samsca® | Tolvaptan | | Jynarque® | Tolvaptan |
| Samsca®, Jynarque® | Tolvaptan | | 517 | | | 1/1/2025 | Rx.01.135 | Commercial | VanHorn, Lynnsey | Q3-2024 | Urea Cycle disorders are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH3, NH4+). Absence of these enzymes or transporters results in the accumulation of toxic levels of ammonia in the blood and brain of affected patients.
Glycerol phenylbutyrate binds to nitrogen waste product and allows excretion via the urine. Glycerol phenylbutyrate is a triglyceride containing 3 molecules of phenylbutyrate (PBA). Phenylacetate (PAA), the major metabolite of PBA, is the active moiety of glycerol phenylbutyrate. PAA conjugates with glutamine (which contains 2 molecules of nitrogen) via acetylation in the liver and kidneys to form phenylacetylglutamine (PAGN), which is excreted by the kidneys. On a molar basis, PAGN, like urea, contains 2 moles of nitrogen and provides an alternate vehicle for waste nitrogen excretion
Glycerol phenylbutyrate (Ravicti®) is indicated for long-term management of urea cycle disorder in patients who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Sodium phenylbutyrate (Buphenyl®) is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.
Sodium phenylbutyrate (Olpruva™) is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
Sodium phenylbutyrate (Pheburane®) is indicated as adjunctive terapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS). | The intent of this policy is to communicate the medical necessity criteria for Buphenyl® tablet and powder, sodium phenylbutyrate oral suspension (Olpruva™), Pheburane®, glycerol phenylbutyrate (Ravicti®), generic sodium phenylbutyrate tablet and powder as provided under the member's prescription drug benefit.
| INITIAL CRITERIA Brand Buphenyl® tablet and powder, sodium phenylbutyrate oral suspension (Olpruva™), Pheburane®, glycerol phenylbutyrate (Ravicti®), generic sodium phenylbutyrate tablet and powder are medically necessary when ALL of the following are met: - Diagnosis of Urea Cycle Metabolism Disorder; and
- Member has one of the following deficiencies:
- Carbamylphosphate synthetase (CPS), or
- Ornithine transcarbamylase (OTC), or
- Argininosuccinic acid synthetase (AS); and
- Molecular genetic testing confirms mutations in the CPS1, OTC, or ASS1 gene; and
- Member cannot be managed by dietary protein restriction and/or amino acid supplementation alone; and
- For brand Buphenyl tablet and powder, Olpruva, Ravicti only, ONE of the following:
- For members 18 years of age or older, inadequate response or inability to tolerate Pheburane and generic sodium phenylbutyrate tablet or powder; or
- For members less than 18 years of age, inadequate response or inability to tolerate Pheburane or generic sodium phenylbutyrate tablet or powder; and
- Will be used concomitantly with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, protein-free calorie supplements, arginine, etc.); and
- Prescribed by or in consultation with a specialist experienced with the treatment of metabolic disorders
Initial authorization duration: 6 months
REAUTHORIZATION CRITERIA Brand Buphenyl® tablet and powder, generic sodium phenylbutyrate tablet and powder, Pheburane®, Glycerol phenylbutyrate (Ravicti®) and sodium phenylbutyrate oral suspension (Olpruva™) is medically necessary when BOTH of the following are met: - Documentation of positive clinical response to therapy; and
- Will be used concomitantly with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, protein-free calorie supplements, arginine, etc.)
Reauthorization duration: 2 years
| | | Ah Mew N, Simpson KL, Gropman AL, et al. Urea Cycle Disorders Overview. 2003 [updated 2017]. In: Adam MP, Ardinger HH, Pagon RA, Wallace SE, Bean LJH, Gripp KW, Mirzaa GM, Amemiya A, eds. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993–2022. Urea Cycle Disorders Overview - GeneReviews® - NCBI Bookshelf (nih.gov). Accessed October 15, 2024
Buphenyl® (sodium phenylbutyrate) [prescribing information]. Deerfiedl, IL. Horizon Therapeutics USA, Inc. March 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463a36fa-3eb2-4326-8bd0-c8c7a11bca3a. Accessed October 15, 2024.
Häberle J, Burlina A, Chakrapani A, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders: First revision. J Inherit Metab Dis. 2019;42(6):1192-1230. doi: 10.1002/jimd.12100.
Olpruva® (sodium phenylbutyrate) [prescribing information]. Newton, MA: Acer Therapeutics Inc. December 2022. Available from: https://www.acertx.com/wp-content/uploads/2022/12/OLPRUVA-Prescribing-Information.pdf. Accessed October 15, 2024. Pheburane® (sodium phenylbutyrate) [prescribing information]. Princeton, NJ: Medunik USA, Inc. August 2023. Avaialable from: https://files.medunik.com/usa/pheburane/prescribing-information.pdf. Accessed October 15, 2024. Ravicti® (glycerol phenylbuterate) [package insert]. Lake Forest, IL. Horizon Therapeutics, LLC. September 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf#page=1. Accessed October 15, 2024.
UpToDate. Urea Cycle Disorders Management. Available
at:https://www.uptodate.com/contents/urea-cycle-disordersmanagement?search=urea%20cycle%20disorders&source=search_result&selectedTitle
=2~42&usage_type=default&display_rank=2. Accessed October 15, 2024
Urea cycle disorders. Available at: http://nordphysicianguides.org/urea-cycle-disorders/what-are-urea-cycle-disorders/. Accessed October 15, 2024.
| 13 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:17 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Ravicti® | Gylcerol Phenylbutrate | | Pheburane® | sodium phenylbutyrate oral pellets | | Buphenyl® | sodium phenylbutyrate tablet/powder |
| N/A | N/A | | 519 | | | 1/1/2025 | Rx.01.208 | Commercial | VanHorn, Lynnsey | Q3-2024 | Idiopathic thrombocytopenia purpura (ITP): ITP is an immune disorder in which the blood doesn't clot normally. ITP can cause excessive bruising and bleeding and can be characterized as an unusually low level of platelets, or thrombocytes, in the blood results in ITP. Thrombocytopenia in patients with hepatitis C: Thrombocytopenia can occur in patients with chronic hepatitis C virus (HCV) infection. The pathophysiology is multifactorial and includes direct bone marrow suppression, an overactive spleen, decreased production of thrombopoietin and therapeutic adverse effect all contributing to thrombocytopenia. Aplastic Anemia: A blood disorder caused by failure of the bone marrow to make enough new blood cells. Bone marrow is a sponge-like tissue inside the bones that makes stem cells that differentiate into red blood cells, white blood cells, and platelets. Thrombocytopenia in patients with chronic liver disease: Individuals with chronic liver disease have varying degree of thrombocytopenia which may be caused by impaired platelet production from decreased hepatic synthesis of thrombopoietin. In addition, individuals with advanced liver disease may have reduced platelet function due to coexisting uremia, infection, and/or endothelial abnormalities. These factors combined put the individuals with chronic liver disease at an increased risk for bleeding especially during procedures. Mechanism of Action: Eltrombopag olamine (Promacta®) tablets contain a thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor which initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells ultimately increasing platelet production. Eltrombopag olamine (Promacta®) is a thrombopoietin receptor agonist indicated for the treatment of: - Thrombocytopenia in adult and pediatric patients 1 year and older with chronic idiopathic thrombocytopenia purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
- Thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should only be used in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
- In combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
- Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Fostamatinib disodium (Tavalisse™) is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK). The major metabolite of fostamatinib, R406, inhibits signal transduction of Fc-activating receptors and B-cell receptor. The fostamatinib metabolite R406 reduces antibody-mediated destruction of platelets.
Fostamatinib disodium (Tavalisse™) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Avatrombopag (Doptelet®) and lusutrombopag (Mupleta®) tablets contain a thrombopoietin (TPO) receptor agonist for oral administration. They stimulate proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production. Lusutrombopag induces megakaryocyte maturation by interacting with the transmembrane domain of human TPO receptor expressed on megakaryocytes. Avatrombopag (Doptelet®) and Lusutrombopag (Mupleta®)are indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Doptelet® (avatrombopag) is also indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Alvaiz™ (eltrombopag choline) is a thrombopoietin receptor agonist indicated: - for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
- for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or
- limits the ability to maintain interferon-based therapy.
- for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
| The intent of this policy is to communicate the medical necessity criteria for eltrombopag choline (Alvaiz™), eltrombopag olamine (Promacta®), fostamatinib disodium (Tavalisse™), avatrombopag (Doptelet®), lusutrombopag (Mulpleta®) as provided under the member's prescription drug benefit.
| Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) INITIAL CRITERIA: Eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) is approved when ALL of the following are met: - Diagnosis of relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP) for greater than 6 months; and
- ONE of the following:
- For eltrombopag olamine (Promacta®) only, member is 1 year of age or older; or
- For eltrombopag choline (Alvaiz™) only, member is 6 years of age or older; and
- Baseline platelet count is less than 30,000/mcL; and
- Insufficient response to corticosteroids, immunoglobulins, or splenectomy; and
- Prescribed by or in consultation with a hematologist/oncologist ; and
- Member's degree of thrombocytopenia and clinical condition increase the risk of bleeding
INITIAL CRITERIA: Fostamatinib (Tavalisse™) is approved when all of the following are met: - Diagnosis of relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP); and
- Baseline platelet count is less than 30,000/mcL; and
- Member's degree of thrombocytopenia and clinical condition increase the risk of bleeding; and
- Documentation of an inadequate response or inability to tolerate ONE of the following:
- Corticosteroids; or
- Immunoglobulins; or
- Splenectomy; or
- Thrombopoietin receptor agonists (e.g., Nplate®, Promacta®); or
- Rituximab; and
- Prescribed by or in consultation with a hematologist/oncologist; and
- Member is 18 years of age or older
Initial authorization duration: 2 years
INITIAL CRITERIA: Avatrombopag (Doptelet®) is approved when ALL of the following are met: - Diagnosis of relapsed/refractory chronic immune thrombocytopenia purpura (ITP); and
- Baseline platelet count is less than 30,000mcL; and
- Inadequate response or inability to tolerate ONE of the following:
- corticosteroids; or
- immunoglobulins; or
- splenectomy; or
- Rituxan (rituximab); and
- Member's degree of thrombocytopenia and clinical condition increase the risk of bleeding; and
- Prescribed by or in consultation with a hematologist/oncologist; and
- Member is 18 years of age or older
Initial authorization duration: 2 years
CONTINUATION CRITERIA: Eltrombopag olamine (Promacta®), eltrombopag choline (Alvaiz™), Fostamatinib (Tavalisse™), avatrombopag (Doptelet®) is re-approved when ALL of the following are met: - Diagnosis of chronic immune (idiopathic) thrombocytopenic purpura; and
- Documentation of a positive clinical response to Promacta®, Alvaiz™, Tavalisse™, Doptelet® therapy as evidence by an increase in platelet count to a level sufficient to avoid clinically important bleeding; and
- Prescribed by or in consultation with a hematologist/oncologist
Continuation authorization duration: 2 years.
Aplastic anemia
INITIAL CRITERIA: Eltrombopag olamine (Promacta®) is approved when ALL of the following are met:
- Diagnosis of severe aplastic anemia; and
- Member is 2 years of age or older; and
- One of the following:
- Inadequate response or inability to tolerate immunosuppressive therapy with antithymocyte globulin (ATG) and cyclosporine; or
- Documentation that the requested drug will be used in combination with antithymocyte globulin (ATG) and cyclosporin and
- Member has thrombocytopenia defined as platelet count less than 30,000/mcL; and
- Prescribed by or in consultation with a hematologist/oncologist
Initial authorization duration: 2 years INITIAL CRITERIA: Eltrombopag choline (Alvaiz™) is approved when ALL of the following are met: - Diagnosis of refractory severe aplastic anemia; and
- Member is 18 years of age or older; and
- Inadequate response or inability to tolerate immunosuppressive therapy with antithymocyte globulin (ATG) and cyclosporine; and
- Member has thrombocytopenia defined as platelet count less than 30,000/mcL; and
- Prescribed by or in consultation with a hematologist/oncologist
Initial authorization duration: 16 weeks
CONTINUATION CRITERIA: Eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) is re-approved when ALL of the following are met: - Diagnosis of severe aplastic anemia; and
- Documentation of a positive clinical response to therapy as evidenced by an increase in platelet count; and
- Prescribed by or in consultation with a hematologist/oncologist
Continuation authorization duration: 2 years
Thrombocytopenia associated with hepatitis C
INITIAL CRITERIA: Eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) is approved when ALL of the following are met: - Diagnosis of thrombocytopenia associated with hepatitis C; and
- Member is 18 years of age or older; and
- ONE of the following:
- Member has thrombocytopenia defined as platelets less than 90,000/mcL for initiation (pre-treatment) of interferon-based therapy; or
- Member has thrombocytopenia defined as platelets less than 75,000/mcL for maintenance of optimal interferon-based therapy; and
- Prescribed by or in consultation with one of the following:
- Hematologist/ oncologist
- Gastroenterologist
- Hepatologist
- Infectious disease specialist
- HIV specialist
Initial authorization duration: 48 weeks
CONTINUATION CRITERIA: Eltrombopag olamine (Promacta®) or eltrombopag (Alvaiz®) is re-approved when ALL of the following are met: - Diagnosis of thrombocytopenia associated with hepatitis C; and
- ONE of the following:
- For members that started treatment with eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) prior to initiation of treatment with interferon, BOTH of the following:
- Member is currently on antiviral interferon therapy for treatment of chronic hepatitis C, and
- Member reached a threshold platelet count that allows initiation of antiviral interferon therapy with eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) treatment by week 9; or
- For members that started treatment with eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) while on concomitant treatment with interferon, member is currently on antiviral interferon therapy for treatment of chronic hepatitis C; and
- Prescribed by or in consultation with one of the following:
- Hematologist/ oncologist
- Gastroenterologist
- Hepatologist
- Infectious disease specialist
- HIV specialist
Continuation authorization duration: 48 weeks
Thrombocytopenia in Chronic Liver Disease Prior to Planned Procedure Lusutrombopag (Mulpleta®) or Avatrombopag (Doptelet®) is approved when ALL of the following are met: - Diagnosis of thrombocytopenia; and
- Member has chronic liver disease; and
- Member is scheduled to undergo a procedure; and
- Baseline platelet count is less than 50,000/mcL; and
- Member is 18 years of age or older; and
For Lusutrombopag (Mulpleta®) only, inadequate response or inability to tolerate avatrombopag (Doptelet®)
Approval duration: 1 month
| Promacta® (eltrombopag olamine): WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY
In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. PROMACTA may increase the risk of severe and potentially lifethreatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended.
Alvaiz™ (eltrombopag choline): WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY
In patients with chronic hepatitis C, ALVAIZ in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ALVAIZ may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended.
| | “Aplastic Anemia." Genetic and Rare Diseases Information Center, National Institute of Health, 5 July 2017, rarediseases.info.nih.gov/diseases/5836/aplastic-anemia. Accessed October 10, 2024.
Dahal, Sumit, et al. “Thrombocytopenia in Patients with Chronic Hepatitis C Virus Infection." Advances in Pediatrics., U.S. National Library of Medicine, 1 Mar. 2017, www.ncbi.nlm.nih.gov/pmc/articles/PMC5333732/. Accessed October 10, 2024.
Doptelet® (avatrombopag) [package insert]. Durham, NC. AkaRx, Inc. July 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e2d5960d-6c18-46cc-86bd-089222b09852&type=display. Accessed October 10, 2024.
Eltrombopag olamine (Promacta®) [package insert]. Basel, Switzerland. Novartis Pharmaceuticals Co. Ltd. March 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7714a0ed-34bb-46e6-a0a5-b363908b22c2&type=display. Accessed October 10, 2024.
Mulpleta® (lusutrombopag) [package insert]. Florham Park, NJ. Shionogi Inc., April 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f9fd0cfd-717d-4a87-99bc-de7b38807e55&type=display. Accessed October 10, 2024.
Shah, N. MD, Intagliata, N, MD. March 2024. Hemostatic abnormalities in patients with liver disease. UpToDate. Access October 10, 2024.
“Idiopathic Thrombocytopenic Purpura (ITP)." Mayo Clinic, Mayo Foundation for Medical Education and Research, June 2023, www.mayoclinic.org/diseases-conditions/idiopathic-thrombocytopenic-purpura/diagnosis-treatment/drc-20352330. Accessed October 10, 2024.
Tavalisse™ (fostamatinib) [package insert]. San Francisco, CA. Rigel Pharmaceutical, Inc. November 2020. Available from: https://tavalisse.com/downloads/pdf/Tavalisse-Full-Prescribing-Information.pdf. Accessed October 10, 2024.
| 11 | 9/12/2024 | 6/6/2025 | 1/1/2025 1:18 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Promacta® | Eltrombopag olamine | | Tavalisse™ | fostamatinib | | Doptelet® | avatrombopag | | Mulpleta® | lusutrombopag | | Alvaiz™ | eltrombopag choline
|
| N/A | N/A | | 525 | | | 1/1/2025 | Rx.01.297 | Commercial | VanHorn, Lynnsey | Q3-2024 | Generalized pustular psoriasis (GPP) is a rare and severe inflammatory skin condition that can be life-threatening if untreated. It is characterized by recurrent, widespread eruptions of painful, sterile pustules which is generally accompanied by fever, chills, headache, rapid pulse rate, loss of appetite, nausea and muscle weakness. The severity of GPP flares can vary, relapses are common. GPP is a distinct disease from other forms of psoriasis such as plaque psoriasis. Spesolimab-sbzo (Spevigo) is the first FDA approved treatment for GPP.
Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by its ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways. The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.
SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
Spevigo SQ in used for treatment of GPP when the patient is not experiencing a flare and it is given after IV loading dose. Only Spevigo IV is used for treatment of GPP flare.
| The intent of this policy is to communicate the medical necessity criteria for Spesolimab-sbzo (Spevigo®) as provided under the member's prescription drug benefit.
| INITIAL CRITIERIA: Spesolimab-sbzo (Spevigo®) is medically necessary when ALL of the following are met: - Diagnosis of generalized pustular psoriasis (GPP) as defined by both of the following:
- Primary, sterile, macroscopically visible pustules on non-acral skin (excluding cases where pustulation is restricted to psoriatic plaques); and
- Disease is relapsing (>1 episode) or persistent (>3 months); and
- Subcutaneous formulation will not be used to treat GPP flare; and
- Both of the following:
- Member is 12 years of age or older; and
- Member weighs at least 40 kg; and
- Prescribed by or in consultation with a dermatologist
Initial authorization duration: 12 months
REAUTHORIZATION CRITERIA: Spesolimab-sbzo (Spevigo®) is re-approved with documentation of positive clinical response to therapy (e.g., reduction in the number of flares)
Reauthorization duration: 12 months
| | | Genetic and Rare Disease Information Center. Generalized pustular psoriasis. Updated September 2024. Available at: https://rarediseases.info.nih.gov/diseases/12819/generalized-pustular-psoriasis. Assessed October 17, 2024
Spevigo (spesolimab-sbzo) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. March 2024. Available at: Prescribing Information (boehringer-ingelheim.com). Accessed October 17, 2024.
| 1 | 9/12/2024 | 9/11/2025 | 1/1/2025 1:19 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Spevigo® SQ | Spesolimab-sbzo |
| SPEVIGO INJ 150/1ML | SPESOLIMAB-SBZO SUBCUTANEOUS SOLN PREF SYR 150 MG/ML | | 526 | | | 1/1/2025 | Rx.01.226 | Commercial | VanHorn, Lynnsey | Q3-2024 | Seizures can result from a shift in the normal balance of excitation and inhibition within the CNS as well as abnormal brain function. Epilepsy is a chronic medical disorder when two or more unprovoked seizures occur that can't be explained by a medical condition. Abnormal, excessive, and hypersynchronous electrical discharge of neurons in the brain can manifest epileptic seizures. Seizure clusters, also known as acute repetitive seizures are frequent seizure activities that are distinct from a patient's usual seizure pattern. Benzodiazepines are used as a rescue medication for seizure clusters in an outpatient setting. Midazolam (Nayzilam®) nasal spray is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. Diazepam (Valtoco®) nasal spray is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.
Diazepam (Libervant™) buccal film is indicated for the acute treatment of intermittent, stereotypic episodes of
frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a
patient’s usual seizure pattern in patients with epilepsy 2 to 5 years of age. The exact mechanism of action for Nayzilam® and Valtoco® is not fully understood, but it is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor.
| The intent of this policy is to communicate the medical necessity criteria for midazolam (Nayzilam®) nasal spray, diazepam (Valtoco®) nasal spray, and diazepam (Libervant™) buccal film as provided under the member's prescription drug benefit.
| INITIAL CRITERIA: Midazolam (Nayzilam®), Diazepam (Libervant™) buccal film or Diazepam (Valtoco®) nasal spray is approved when ALL of the following are met: - Diagnosis of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern; and
- ONE of the following:
- For midazolam (Nayzilam®) only, member is 12 years of age or older; or
- For diazepam (Libervant™) only, member is 2 to 5 years of age; or
- For diazepam (Valtoco®) only, member is 6 years of age or older; and
- Prescribed by or in consultation with a neurologist/epilepsy specialist
Initial Authorization duration: 2 years
REAUTHORIZATION CRITERIA: Midazolam (Nayzilam®) nasal spray, Diazepam (Libervant™) buccal film or diazepam (Valtoco®) nasal spray is reapproved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
| Benzodiazepines (Nayzilam®, Valtoco®, Libervant): Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. The unapproved use benzodiazepines (Nazyilam, Valtoco, Libervant) exposes users
to risks of abuse, misuse, and addiction, which can lead to
overdose or death. Assess each patient’s risk for abuse,
misuse, and addiction.
Although benzodiazepine (Nayzilam, Valtoco, Libervant) is indicated only for intermittent use, if used more frequently than recommended, abrupt
discontinuation or rapid dosage reduction of benzodiazepine (Nayzilam, Valtoco, Libervant) may
precipitate acute withdrawal reactions, which can be life-threatening. For patients using benzodiazepine (Nayzilam, Valtoco, Libervant) more frequently
than recommended, to reduce the risk of withdrawal reactions,
use a gradual taper to discontinue benzodiazepine (Nayzilam, Valtoco, Libervant).
| | Libervant™ (diazepam buccal film) [prescribing information]. Warren, NJ: Aquestive Therapeutics, Inc.; April 2024. Available from libervant-2-to-5-years-of-age-pi-clean-pdf.pdf (aquestive.com). Accessed October 11, 2024.
Nayzilam® (midazolam nasal spray) [prescribing information]. Smyrna, GA: UCB Inc.; January 2023. Available from: https://www.ucb-usa.com/_up/ucb_usa_com_kopie/documents/Nayzilam_PI.pdf. Accessed October 11, 2024.
Valtoco® (diazepam nasal spray) [prescribing information]. San Diego, CA: Neurelis, Inc.; January 2023. Available from: https://www.valtoco.com/sites/default/files/Prescribing_Information.pdf. Accessed October 11, 2024.
Jafarpour, Saba & Hirsch, Lawrence & Gaínza-Lein, Marina & Kellinghaus, Christoph & Detyniecki, Kamil. (2018). Seizure cluster: Definition, prevalence, consequences, and management. Seizure. 68. 10.1016/j.seizure.2018.05.013. October 11, 2024.
| 6 | 9/12/2024 | 3/14/2025 | 1/1/2025 1:19 AM | srv_ppsgw_P | Rx.01.33 Off-Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
| | Brand name | Generic name | | Nayzilam® | Midazolam | | Valtoco® | Diazepam | | Libervant™ | Diazepam |
| LIBERVANT MIS | DIAZEPAM BUCCAL FILM 10 MG, 12.5 MG, 15 MG, 5 MG, 7.5 MG | | 527 | | | 1/1/2025 | Rx.01.88 | Commercial | VanHorn, Lynnsey | Q3-2024 | Huntington's disease (HD) is an inherited, progressive, neurodegenerative disease with no cure or disease modifying therapies currently available. The disease is characterized by choreiform movements, psychiatric problems, and dementia. Therapy focuses on management of symptoms and supportive care. There are approximately 30,000 Americans with symptomatic HD. Symptoms usually appear between the ages of 30 and 50 and progressively worsen.
Chorea is a hyperkinetic movement disorder that may manifest in association with Huntington's Disease. Chorea is characterized by involuntary brief, random, and irregular contractions. Anti-chorea medications such as tetrabenazine, deutetrabenazine and valbenazine may be useful for controlling chorea in the setting of Huntington's disease, especially milder forms of chorea. Other treatment options include atypical and typical neuroleptics, amantadine, and riluzole.
Tardive dyskinesia is a movement disorder that is characterized by random movement of various facial muscles, including the tongue and jaw. In more severe cases, it may also involve movements of the arms, legs, fingers, toes, trunk or hips. A common risk factor for developing tardive dyskinesia is long-term treatment with antipsychotic medications. It has particularly been associated with first-generation antipsychotic treatment, but there are reports of patients receiving second-generation antipsychotics developing tardive dyskinesia.
Tourette syndrome (TS) is a neurological disorder manifested by motor and phonic tics with onset during childhood. Tics are the clinical hallmark of TS. Tics are sudden, brief, intermittent movements (motor tics) or utterances (phonic tics). Tics have been considered involuntary, but tics can temporarily be voluntarily suppressed.
Mechanism of Action: Tetrabenazine,deutetrabenazine, and valbenazine reversibly inhibit the human vesicular monoamine transporter type 2 (VMAT2) resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monamine stores.
Tetrabenazine (Xenazine®), valbenazine (Ingrezza), and deutetrabenazine (Austedo® [XR]) are indicated for the treatment of chorea associated with Huntington's disease.
Deutetrabenazine (Austedo® [XR]) and valbenazine (Ingrezza®) are indicated for the treatment of adults with tardive dyskinesia.
| The intent of this policy is to communicate the medical necessity criteria for tetrabenazine (Xenazine®), deutetrabenazine (Austedo® [XR]) and valbenazine (Ingrezza®) as provided under the member's prescription drug benefit.
| Chorea associated with Huntington's disease INITIAL CRITERIA: Tetrabenazine (Xenazine®), Valbenazine (Ingrezza®) or deutetrabenazine (Austedo® [XR]) is approved when ALL of the following are met:
- Used for the treatment of chorea associated with Huntington's disease; and
- Member is 18 years of age or older; and
- Prescribed by or in consultation with a neurologist; and
- For brand Xenazine® only, inadequate response or inability to tolerate a minimum 30-day supply of generic tetrabenazine
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Tetrabenazine (Xenazine®), Valbenazine (Ingrezza®) or deutetrabenazine (Austedo® [XR]) is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
Tardive Dyskinesia INITIAL CRITERIA: Valbenazine (Ingrezza®) or deutetrabenazine (Austedo® [XR]) is approved when ALL of the following are met:
- Diagnosis of moderate to severe tardive dyskinesia; and
- Member is 18 years of age or older; and
- One of the following:
- Persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication; or
- Member is not a candidate for a trial of dose reduction, tapering, or discontinuation of the offending medication; and
- Prescribed by or in consultation with one of the following:
- Neurologist; or
- Psychiatrist
Initial Authorization duration: 3 months
REAUTHORIZATION CRITERIA: Valbenazine (Ingrezza®) or deutetrabenazine (Austedo® [XR]) is re-approved with documentation of positive clinical response to therapy.
Reauthorization
duration: 2 years
Tourette's syndrome
INITIAL CRITERIA: Tetrabenazine (Xenazine®) is approved when ALL of the following are met:
- Diagnosis of Tourette's Syndrome; and
- Member has tics associated with Tourette's syndrome; and
- Inadequate response or inability to tolerate haloperidol or risperidone; and
- Prescribed by or on consultation with a neurologist or a psychiatrist; and
- For brand Xenazine® only, inadequate response or inability to tolerate a minimum 30-day supply of generic tetrabenazine
Initial authorization duration: 2 years
REAUTHORIZATION CRITERIA: Tetrabenazine (Xenazine®) is re-approved when there is documentation of positive clinical response to therapy.
Reauthorization duration: 2 years
| TETRABENAZINE (Xenazine®), DEUTETRABENAZINE (Austedo® [XR]), and VALBENAZINE (Ingrezza®): DEPRESSION AND SUICIDALITY
Tetrabenazine, deutetrabenazine, and valbenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Balance risks of depression and suicidality with the clinical need for control of chorea when considering the use of tetrabenazine, deutetrabenazine, and valbenazine. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Inform patients, caregivers, and families of the risk of depression and suicidality, and instruct them to report behaviors of concern promptly to the treating physician.
Exercise caution in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington disease. Tetrabenazine and deutetrabenazine are contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression.
| | Austedo® [XR] (deutetrabenazine) [ package insert]. North Wales, PA. Teva Pharmaceuticals. September 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7ea3c60a-45c7-44cc-afc2-d87fa53993c0&type=display. Accessed October 10, 2024. Ingrezza® (valbenazine) [package insert]. San Diego, CA: Neurocrine Biosciences. April 2024. Available at: https://ingrezza.com/HCP/PI. Accessed October 10, 2024. Jankovic, J. Tourette Syndrome: Pathogenesis, clinical features, and diagnosis. UpToDate. December 2023. Available at: https://www.uptodate.com/contents/tourette-syndrome-pathogenesis-clinical-features-and-diagnosis?search=tourette%20syndrome&source=search_result&selectedTitle=1~23&usage_type=default&display_rank=1. Assessed October 10, 2024. Suchowersky O. Overview of chorea. UpToDate. March 2024. Available at: https://www.uptodate.com/contents/overview-of chorea?source=machineLearning&search=chorea&selectedTitle=1~102§ionRank=2&anchor=H29672870#H29672870. Accessed October 10, 2024. Suchowersky O. Huntington's disease: management. UpToDate. December 2023. Available at: https://www.uptodate.com/contents/huntington-disease-management?source=search_result&search=huntingtons&selectedTitle=2~50. Accessed October 10, 2024. Xenazine® (tetrabenazine) [package insert]. Deerfield, IL. Lundbeck. November 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ac768bab-8afa-4446-bc7f-caeeffec0cda&type=display. Accessed October 10, 2024. Tarditive Dyskinesia. National Alliance on Mental Illness Web Site. https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Tardive-Dyskinesia. Accessed October 10, 2024. What is Huntington's Disease? Huntington's Disease Society of America Web Site. https://hdsa.org/what-is-hd/overview-of-huntingtons-disease/. Accessed October 10, 2024. Wimalasena K. Vesicular monoamine transporters: Structure-function, pharmacology, and medicinal chemistry. Med Res Rev. 2010;31(4):483-519. doi:10.1002/med.20187. Accessed October 10, 2024.
| 18 | 9/12/2024 | 3/14/2025 | 1/1/2025 1:19 AM | srv_ppsgw_P | | | Brand Name | Generic Name | | Xenazine® | Tetrabenazine | Austedo® [XR]
| Deutetrabenazine
| Ingrezza®
| Valbenazine |
| INGREZZA CAP | VALBENAZINE TOSYLATE CAPSULE SPRINKLE 40 MG (BASE EQUIV), 60 MG, 80 MG |
|