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10/1/2025Rx.01.184CommercialVanHorn, LynnseyQ2-2025
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 medically necessary when both of the following are met:

  1. Diagnosis of an FDA approved, or compendia supported, indication; and
  2. Inadequate response or inability to tolerate BOTH of the following (when available):
    1. One generic alternative with the same indication; and
    2. One preferred brand with the same indication

Authorization duration: 1 year

A new authorized generic/authorized brand alternative is medically necessary when all of the following are met:

  1. Diagnosis of an FDA approved, or compendia supported, indication; and
  2. 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
  3. Submission of documentation (e.g., chart note) confirming BOTH of the following:
    1. The brand product has not been effective; and
    2. 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

None
None
106/5/20256/4/202610/1/2025 1:15 AMNo presence informationsrv_ppsgw_P
Rx. 01.33 ​Off-Label Use 
Applicable drugs will vary as new products are released to market.
N/AN/A
525
  
1/1/2025Rx.01.297CommercialVanHorn, LynnseyQ3-2024
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:

  1. Diagnosis of generalized pustular psoriasis (GPP) as defined by both of the following:
    1. Primary, sterile, macroscopically visible pustules on non-acral skin (excluding cases where pustulation is restricted to psoriatic plaques); and
    2. Disease is relapsing (>1 episode) or persistent (>3 months); and
  2. Subcutaneous formulation will not be used to treat GPP flare; and
  3. Both of the following:
    1. Member is 12 years of age or older; and
    2. Member weighs at least 40 kg; and
  4. 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


None

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. 


19/12/20249/11/20251/1/2025 1:19 AMNo presence informationsrv_ppsgw_P
​Off-Label Use Rx.01.33
​Brand Name​Generic Name
​Spevigo® SQ​Spesolimab-sbzo

SPEVIGO      INJ 150/1MLSPESOLIMAB-SBZO SUBCUTANEOUS SOLN PREF SYR 150 MG/ML
485
  
1/1/2025Rx.01.87CommercialVanHorn, LynnseyQ3-2024

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:

  1. The member is 18 years of age or older; and
  2. ONE of the following:
    1. Primary or hypogonadal osteoporosis in men; or
    2. Glucocorticoid-induced osteoporosis in men or women (daily dose greater than or equal to 5mg prednisone or equivalent for at least 3 months); and
  3. ONE of the following:
    1. Member is high risk for fracture defined by ONE of the following:
      1. History of osteoporotic fractures (low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm); or
      2. 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
      3. Member has a T score of at least -2.5 standard deviations below the young adult mean (T-score ≤ -2.5); or
    2. Inadequate response or inability to tolerate ONE of the following osteoporosis therapies:
      1. Bisphosphonates; or
      2. Hormone replacement therapy; or
      3. Selective estrogen receptor modulators (SERMs); or
      4. Calcitonin salmon (Miacalcin); or
      5. Denosumab (Prolia); and
  4. 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:

  1. Documentation of positive clinical response; and
  2. ONE of the following:
    1. Cumulative lifetime therapy does not exceed 2 years; or
    2. 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:

  1. The member is 18 years of age or older; and
  2. Diagnosis of postmenopausal osteoporosis; and
  3. ONE of the following:
    1. Member is high risk for fracture defined by ONE of the following:
      1. Member has a T score of at least -2.5 standard deviation below the young adult mean (T-score ≤ -2.5); or
      2. History of osteoporotic fractures (low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm); or
      3. 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
    2. Inadequate response or inability to tolerate ONE of the following osteoporosis therapies:
      1. Bisphosphonates; or
      2. Hormone replacement therapy; or
      3. Selective-estrogen receptor modulators (SERMs); or
      4. Calcitonin-salmon (Miacalcin®); or
      5. Denosumab (Prolia®); and
  4. 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:

  1. Documentation of positive clinical response; and
  2. ONE of the following:
    1. Cumulative lifetime therapy does not exceed 2 years; or
    2. 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:

  1. Diagnosis of primary or hypogonadal osteoporosis; and
  2. The member is 18 years of age or older; and
  3. Both of the following:
    1. 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
    2. One of the following:
      1. History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm; or
      2. 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:
  1. Documentation of positive clinical response; and
  2. 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.)

N/A

Forteo® (teriparatide) [package insert]. Indianapolis, IN. Lilly USA, LLC. April 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=aae667c5-381f-4f92-93df-2ed6158d07b0&type=display. Accessed October 14, 2024.

Prolia® (denosumab) [package insert]. Thousand Oaks, CA. Amgen Inc. January 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88&type=display. Accessed October 14, 2024.

Rosen CJ. Parathyroid hormone/parathyroid hormone-related protein analog for osteoporosis. UpToDate. January 2023. Available at: https://www.uptodate.com/contents/parathyroid-hormone-therapy-for-osteoporosis?source=search_result&search=teriparatide&selectedTitle=4~150. Accessed October 14, 2024.

Tymlos™ (abaloparatide) [package insert]. Waltham, MA: Radius Health, Inc. December 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8&type=display. Accessed October 14, 2024.


189/12/20249/11/20251/1/2025 1:11 AMNo presence informationsrv_ppsgw_P
Rx.01.33 Off-Label Use

​Brand Name​​Generic Name
​Tymlos™
​abaloparatide
​Forteo®​teriparatide

Tymlos™, Forteo®abaloparatide, teriparatide
486
  
1/1/2025Rx.01.148CommercialVanHorn, LynnseyQ3-2024

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:

  1. Diagnosis of actinic keratosis; and
  2. Member is 18 years of age or older; and 
  3. ONE of the following:
    1. For imiquimod (Zyclara®) 3.75%, 2.5% only, inadequate response or inability to tolerate imiquimod 5%; or
    2. For tirbanibulin (Klisyri®) only, inadequate response or inability to tolerate BOTH of the following generics:
      1. Fluorouracil; and
      2. 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:

  1. Diagnosis of genital warts; and
  2. Member is 12 years of age or older; and
  3. 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&sectionRank=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.​

149/12/20249/12/20251/1/2025 1:12 AMNo presence informationsrv_ppsgw_P
Off-Label Use policy Rx.01.33
Brand NameGeneric Name
Picato®ingenol mebutate

Solaraze®

Klisyri™

diclofenac 3%

Tirbanibulin

Zyclara™Imiquimod

Picato®, Solaraze®,Klisyri®, and Zyclara™ingenol mebutate, diclofenac 3%, tirbanibulin, and imiquimod
597
  
7/1/2025Rx.01.226CommercialVanHorn, LynnseyQ1-2025

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 medically necessary when ALL of the following are met:

  1. 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
  2. ONE of the following:
    1. For midazolam (Nayzilam®) only, member is 12 years of age or older; or
    2. For diazepam (Libervant™) only, member is 2 to 5 years of age; or
    3. For diazepam (Valtoco®) only, member is 6 years of age or older; and
  3. 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 medically necessary when there is documentation of positive clinical response to therapy.

Reauthoriztion 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 February 20, 2025.

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 February 20, 2025.

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 February 20, 2025.

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. Accessed February 20, 2025.

73/20/20253/19/20267/1/2025 1:11 AMNo presence informationsrv_ppsgw_P

Rx.01.33 Off-Label Use 

Rx.01.76​ Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit

Brand nameGeneric name
Nayzilam®Midazolam
Valtoco®Diazepam
Libervant™Diazepam

N/AN/A
431
  
7/1/2024Rx.01.219CommercialOyenusi, OluwadamilolaQ1-2024

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:

  1. Diagnosis of Parkinson's disease and member is experiencing intermittent off episodes; and
  2. Member is 18 years of age or older; and
  3. Concurrent use of carbidopa/levodopa containing product at maximally tolerated dose; and
  4. Prescribed by or in consultation with a neurologist; and
  5. Member had inadequate response or inability to tolerate TWO of the following:
    1. MAO-B Inhibitor (e.g., rasagiline, selegiline); or
    2. Dopamine Agonist (e.g., pramipexole, ropinirole); or
    3. 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:

  1. Documentation of positive clinical response to therapy; and
  2. 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: 

  1. Diagnosis of advanced Parkinson's disease and member is experiencing intermittent "off" episodes; and
  2. Member is 18 years of age or older; and
  3. One of the following:
    1. 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
    2. Member has a contraindication or intolerance to other medications for the treatment of Parkinson's disease; and
  1. Member is not using the medication with any 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron); and
  2. For Apomorphine (Apokyn®) inadequate response or inability to tolerate apomorphine (Kynmobi™); and
  3. 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


None

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.



113/14/20243/14/20257/1/2024 1:31 AMNo presence informationsrv_ppsgw_P
​Rx.01.33 Off-Label Use
​
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit
Brand NameGeneric Name
Inbrija™Levodopa inhalation
Nourianz™Istradefylline
Apokyn®Apomorphine
Kynmobi™Apomorphine


NANA
695
  
10/1/2025Rx.01.158CommercialVanHorn, LynnseyQ2-2025

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 individuals 5 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 medically necessary when ALL of the following are met:

  1. FDA approved indication; and
  2. Member has a positive skin test or in vitro test for ONE of the listed pollen-specific IgE antibodies:
    1. Timothy Grass or cross-reactive grass pollens (GRASTEK® only); or
    2. Any of the five grass species including sweet vernal, orchard perennial rye, timothy or Kentucky blue grass mixed pollens (ORALAIR® only); or
    3. Short ragweed pollen (RAGWITEK® only); or
    4. Dermatophagoides farina or Dermatophagoides pteronyssinus house dust mites (ORDACTRA™ only); and
  3. Prescribed by or in consultation with allergist or immunologist and
  4. ONE of the following:
    1. For Grastek, member is between 5 to 65 years of age; or
    2. For Odactra, member is between 5 to 65 years of age; or
    3. For Oralair, member is between 5 to 65 years of age; or
    4. For Ragwitek, member is between 5 to 65 years of age; and
  5. Member does not have any of the following:
    1. Severe, unstable or uncontrolled asthma; or
    2. History of eosinophilic esophagitis; and
  6. Member has had an inadequate response or inability to tolerate BOTH of the following:
    1. Intranasal corticosteroid; and
    2. Antihistamine

Initial Authorization duration: 1 year 

REAUTHORIZATION CRITERIA: Odactra™, Oralair®, Grastek® or Ragwitek® is medically necessary when ALL of the following are met:

  1. Use in the age group supported by FDA labeling; and
  2. Prescribed by or in consultation with allergist or immunologist; and
  3. Member 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 May 28, 2025.

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 May 28, 2025.

Grastek® (Timothy grass pollen allergen extract) [package insert]. Whitehouse Station NJ. Merck and Co, Inc. December 2019. Accessed May 28, 2025.

Odactra™ (and house dust mite allergen extract) [package insert]. Whitehouse Station NJ. Merck and Co, Inc. February 2025. Available from: https://www.odactra.com/assets/pdf/odactra-full-pi.pdf. Accessed May 28, 2025.

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 May 28, 2025.

Ragwitek® (short ragweed pollen allergen extract) [package insert]. Whitehouse Station NJ. Merck and Co, Inc. April 2021. Accessed May 28, 2025. 


166/5/20253/19/202610/1/2025 1:26 AMNo presence informationsrv_ppsgw_P
Rx.01.33  Off- Label Use 
Brand NameGeneric 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

Odactra® Dermatophagoides farinae and Dermatophagoides pteronyssinus
487
  
1/1/2025Rx.01.267CommercialVanHorn, LynnseyQ3-2024
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:

  1. Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS); and
  2. Documentation of mutation in the PIK3CA gene; and
  3. Member is 2 years of age or older; and
  4. 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
  5. 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:

  1. 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
  2. Prescribed by or in consultation with a provider who specializes in the treatment of PROS

Reauthorization duration: 12 months 


N/A

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.​


39/12/20249/11/20251/1/2025 1:12 AMNo presence informationsrv_ppsgw_P

Rx.01.33 Off Label Use

Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit​


Brand NameGeneric Name
Vijoice®Alpelisib

Vijoice®Alpelisib
599
  
7/1/2025Rx.01.216CommercialVanHorn, LynnseyQ1-2025

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 medically necessary when ALL of the following are met:

  1. Member has a diagnosis of Lambert-Eaton myasthenic syndrome; and
  2. Member is 6 years of age or older and
  3. Neurological symptoms persist after treatment of malignancy when malignancy is present; and
  4. Documentation of symptomatic LEMS that interfere with daily functions (e.g., difficulty climbing stairs, walking up steep hills); and
  5. Prescribed by or in consultation with a neurologist; and
  6. Member does not have history of seizures

Initial authorization duration: 3 months 

CONTINUATION CRITERIA: Amifampridine (Firdapse®) is medically necessary 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

None

Firdapse® (amifampridine) [prescribing information]. Coral Gables, FL: Catalyst Pharmaceuticals, Inc.  September 2022. Available at: https://www.firdapse.com/pdfs/firdapse-pi.pdf. Accessed February 21, 2025.

Titulaer MJ, Lang B, Verschuuren JJGM. Lambert-Eaton myasthenic syndrome: from clinical characteristics to therapeutic strategies. Lancet Neurol. 2011[a]; 10:1098-1107. Accessed February 21, 2025.

Weinberg DH. Lambert-Eaton myasthenic syndrome: Clinical features and diagnosis. UpToDate Web site. Updated March 2023. www.uptodate.com. Accessed February 21, 2025.

93/20/20253/19/20267/1/2025 1:12 AMNo presence informationsrv_ppsgw_P
Rx.01.33 Off-Label Use
Brand NameGeneric Name
Firdapse®amifampridine phosphate

Firdapse®Amifampridine
655
  
10/1/2025Rx.01.213CommercialVanHorn, LynnseyQ2-2025
​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 medically necessary when ALL of the following are met:

  1. Diagnosis of refractory Mycobacterium avium complex (MAC) lung disease; and
  2. Documentation that the medication will be used as part of a combination antibacterial regimen (e.g., clarithromycin, rifampin and ethambutol); and
  3. Member is 18 years of age or older; and
  4. Prescribed by or in consultation with a pulmonologist or infectious diseases specialist; and
  5. Both of the following:
    1. Patient has received a minimum of 6 consecutive months of a multidrug background regimen therapy (e.g., a macrolide, a rifamycin, ethambutol, etc.) before starting therapy with the requested drug; and
    2. Patient has not achieved at least two negative sputum cultures following this treatment regimen

Initial authorization duration: 6 months

REAUTHORIZATION CRITERIA: Arikayce® (amikacin liposome inhalation suspension) is medically necessary when both of the following are met:

  1. Documentation of positive clinical response to therapy; and
  2. 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 May 29, 2025.

Kasperbauer, S. Treatment of Mycobacterium avium complex pulmonary infections in adults. UpToDate Web site. December 2023. www.uptodate.com. Accessed May 29, 2025.

76/5/20256/4/202610/1/2025 1:11 AMNo presence informationsrv_ppsgw_P
Rx.01.33 Off-Label Use
Brand NameGeneric Name
Arikayce®Amikacin liposome inhalation suspension

Arikayce®Amikacin Liposome Inhalation Suspension
644
  
7/1/2025Rx.01.4CommercialVanHorn, LynnseyQ1-2025
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®, Azmiro™, Fortesta®, Jatenzo®, Tlando®, Natesto®,  Testim®, Vogelxo®, Xyosted™, Kyzatrex®, Undecatrex, 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™, Azmiro™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Undecatrex, Aveed®), or methyltestosterone (Methitest®) is approved when ALL of the following are met:

  1. Diagnosis of primary or secondary hypogonadism; and
  2. Member is 18 years of age or older; and
  3. ONE of the following:
    1. Negative history of prostate and breast cancer; or
    2. History of prostate cancer status post prostatectomy and documentation that the risk versus benefit has been assessed; and
  4. For Androgel®, Androderm®, Fortesta®, Natesto®, Testim®, Vogelxo®, Xyosted™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Undecatrex), methyltestosterone (Methitest®) only, inadequate response or inability to tolerate generic transdermal testosterone; and
  5. For Aveed® and Azmiro™ only, inadequate response or inability to tolerate generic testosterone injection in oil formulation; and
  6. New users only, low (morning) testosterone level

Initial authorization duration: 2 years

REAUTHORIZATION CRITERIA Androgel®, Androderm®, Fortesta®, Natesto®, Testim®, Vogelxo®, Xyosted™, Azmiro™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Undecatrex, 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™, Azmiro™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex® , Undecatrex, 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™, Azmiro™, testosterone undecanoate (Jatenzo®, Tlando®, Kyzatrex®, Undecatrex, 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.
WARNING: BLOOD PRESSURE INCREASES
See full prescribing information for complete boxed warning
  • Testosterone Undecanoate Capsules 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 Testosterone Undecanoate Capsules, 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 Testosterone Undecanoate Capsules outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
  • Due to this risk, use Testosterone Undecanoate Capsules only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

Androderm® (testosterone) [package insert]. Irvine, CA. Allergan USA, Inc. May 2020. Available from: https://www.allergan.com/assets/pdf/androderm_pi. Accessed March 3, 2025. 

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 March 3, 2025. 

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 March 3, 2025. 

AZMIRO (testosterone cypionate [package insert]. Princeton, NJ. Slayback Pharma LLC. February 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216318Orig1s002lbl.pdf. Accessed March 3, 2025. 

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. Accessed March 3, 2025.

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 March 3, 2025. 

Gooren L . Hormone treatment of the adult transsexual patient. Horm Res. 2005;64(Suppl 2):31–36. Accessed March 3, 2025.

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. Accessed March 3, 2025.

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 March 3, 2025. 

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. Accessed March 3, 2025.

Kaufman J, Graydon RJ. Androgen replacement after curative radical prostatectomy for prostate cancer in hypogonadal men. J Urol. 2004;172(3):920-922. Accessed March 3, 2025.

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 March 3, 2025. 

Matsumoto AM. Diagnosis and evaluation of male hypogonadism. Medscape CME. 2008. Available from: http://www.medscape.org/viewarticle/575491. Accessed March 3, 2025. 

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. Accessed March 3, 2025.

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 March 3, 2025. 

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. Accessed March 3, 2025.

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. Accessed March 3, 2025.

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 March 3, 2025. 

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 March 3, 2025. 

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. Accessed March 3, 2025.

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. Accessed March 3, 2025.

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 March 3, 2025. 

Testosterone. Micromedex. Available from: http://www.micromedexsolutions.com. Accessed March 3, 2025. 

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 March 3, 2025. 

Undecatrex™ (Testosterone Undecanoate) Capsules [package insert]. San Antonio, TX. Trifluent Pharma, LLC. September 2022. Available from: https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/0828e67d-8b53-4297-aab8-196ded3dba1f/spl-doc?hl=undecatrex. Accessed March 3, 2025. 

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 March 3, 2025. 

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. Accessed March 3, 2025.

Xyosted™ (testosterone enanthate) injection [package insert]. Ewing, NJ. Antares Pharma, Inc. August 2023. Available at: https://www.xyosted.com/PI.pdf. Accessed March 3, 2025. 

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 March 3, 2025. 

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Rx.01.33 Off-Label Use


Brand NameGeneric Name
Androgel®Testosterone
Androderm®Testosterone
Fortesta®Testosterone
Natesto®Testosterone
Striant®Testosterone
Testim®Testosterone
Vogelxo®Testosterone
Aveed®, Jatenzo®, Tlando®, Kyzatrex®, UndecatrexTestosterone undecanoate
Testred®, Android®, Methitest®Methyltestosterone
Xyosted™Testosterone enanthate
AzmiroTestosterone cypionate

AZMIRO INJ 200MG/MLTESTOSTERONE CYPIONATE IM SOLN PREF SYRINGE IN OIL 200 MG/ML
642
  
7/1/2025Rx.01.2CommercialVanHorn, LynnseyQ1-2025

Age edits are used to ensure appropriate utilization in certain age groups.  An age edit may be placed on a medication when there are concerns for safe use or inappropriate utilization based on indication in a particular age group. Age edits may be based on the FDA approved label, available literature or accepted compendia as listed in the Off-Label Use Policy. When a medication listed below is prescribed to a member outside of the defined age range, the age edit will be applied and prior authorization will be required. 

Retinoids: adapelene (Differin®), tazarotene (Avage®, Tazorac®) and Tretinoin, topical (e.g. Atralin®, Avita®, Retin-A®, Retin A micro®, Altreno™, etc), triafarotene (Aklief®).

Topical retinoids may be used for cosmetic indications, including fine lines and wrinkles, in addition to treating acne. Coverage of medications intended for cosmetic indications is an excluded benefit.  Studies of topical retinoids for fine lines and wrinkles included patients beginning in their 20s.  An age edit for members over the age of 25 years will be applied to ensure indication is not cosmetic.

The intent of this policy is to communicate the medical necessity criteria for medications that have age edits as provided under the member’s prescription drug benefit.


The drugs in the following table are medically necessary in the age ranges listed when there is documentation of all of the following:

  1. FDA or compendia approved indication; and
  2. Not used for an indication that is otherwise excluded (i.e., cosmetic)
***Note: Age edits apply to brand and generic products. Some brand name products have prior authorization in addition to age edit.

Authorization Duration: 2 years

None

Aklief® (trifarotene) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P.: October 2019. Available at: https://www.galderma.com/us/sites/g/files/jcdfhc341/files/2019-10/10-2-2019%20Revised%20PI%20NDA%20211527.pdf. Accessed March 3, 2025.
 
Altreno™ (tretinoin) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceutical North America LLC. March 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1412aba5-71aa-4cce-8db4-c189bed1852c&type=display. Accessed March 3, 2025.
 
Atralin™ (tretinoin) [prescribing information]. Fort Worth, TX: Coria Laboratories, LTD.; July 2016. Revised July 2016. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b6b45969-a64a-4ce3-b3b6-157d2568a301&type=display Accessed March 3, 2025.
 
Amerge® (naratriptan HCl) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Revised October 2020. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=13f4a8ec-75a3-4c51-b3bc-6244f3c79e95&type=display. Accessed March 3, 2025.
 
Arazlo™ (tazarotene) [prescribing information]. Quebec, Canada: Bausch Health Companies Inc. May 2021. Available at: https://www.bauschhealth.com/portals/25/pdf/pi/arazlo-pi.pdf. Accessed March 3, 2025.

Auvi-Q™ (epinephrine) [prescribing information]. Bridgewater, NJ. Sanofi-Aventis U.S. LLC. Revised September 2019. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6180fb40-7fca-4602-b3da-ce62b8cd2470&type=display Accessed March 3, 2025.
 
Avita® (tretinoin) [prescribing information]. Research Triangle Park, NC: Bertek Pharmaceuticals, Inc.; July 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=302ca95f-5a7e-4971-870a-5cfea618d7a7 Accessed March 3, 2025.
 
Hillebrand, G.G., et al. "New Wrinkles on Wrinkling: an 8‐Year Longitudinal Study on the Progression of Expression Lines into Persistent Wrinkles." British Journal of Dermatology, Wiley/Blackwell (10.1111), 22 Feb. 2010, onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2133.2010.09709.x. Accessed March 3, 2025.

Imitrex® (sumatriptan succinate) [prescribing information]. Canada: GlaxoSmithKiline LLC. December 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=32f6d89b-4aea-5396-e054-00144ff88e88. Accessed March 3, 2025.
 
Luebberding, Stefanie, et al. Quantification of Age-Related Facial Wrinkles in Men and... : Dermatologic Surgery. Oxford University Press, 2014, journals.lww.com/dermatologicsurgery/pages/articleviewer.aspx?year=2014&issue=01000&article=00003&type=abstract.  March 3, 2025.
 
Maxalt® (rizatriptan benzoate) [prescribing information]. Whitehouse Station, NJ: Merck& Co., Inc.; 2012. Revised June 2021.  https://www.merck.com/product/usa/pi_circulars/m/maxalt/maxalt_pi.pdf Accessed March 3, 2025.
 
Relpax® (eletriptan) [prescribing information]. New York, NY: Roerig (Pfizer Inc.); 2012. Revised March 2020. http://labeling.pfizer.com/ShowLabeling.aspx?id=621 Accessed March 3, 2025.
 
Retin-A® (tretinoin) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2016. Revised September 2019. Accessed March 3, 2025.
 
Retin-A Micro® (tretinoin) [prescribing information].  Bridgewater, NJ: Valeant Pharmaceuticals North America; 2016. Revised October 2017. Accessed March 3, 2025.
 
Twyneo® (Tretinoin-benzoyl peroxide) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P. July 2021. Available from: https://www.galderma.com/us/sites/default/files/2022-02/Twyneo_PI.pdf. Accessed March 3, 2025.
 
Ziana® (tretinoin/clindamycin) [prescribing information]. Brigewater, NJ: Medicis Pharmaceutical Corp; Revised March 2017. Accessed March 3, 2025.
 
Zomig® (zolmitriptan) [prescribing information]. Macclesfield, Cheshire UK: AstraZeneca Pharmaceuticals; 2012. Revised May 2019.  Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=84b51cb9-83f3-4a49-7fa3-1adc0f963658&type=display. Accessed March 3, 2025.
 
Zomig NS® (zolmitriptan nasal) [prescribing information]. Macclesfield, Cheshire UK: AstraZeneca Pharmaceuticals; 2012. Revised April 2019. https://www.azpicentral.com/zomig_nasal/zomig_nasal.pdf#page=1. Accessed March 3, 2025.
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Rx.01.33 Off Label Use

Rx.01.17 Cosmetic Policy

Rx.01.251 Migraine and Headache agents

Rx.01.202 Prior authorization requirements for select drugs

Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit​

Drug NameAge Edit:  Prior Authorization Required (years)
Acne Medications​
Tretinoin, topical (e.g., Atralin, Avita, Retin-A, Retin-A micro, Altreno, etc.)Age 26 and over
Adapalene (Differin)Age 26 and over
Adapalene/ Benzoyl Peroxide (Epiduo)Age 26 and over
Tretinoin/ clindamycin (Ziana)Age 26 and over
Triafarotene (Aklief)Age 26 and over
Tazarotene (Fabior, Arazlo, Tazorac)Age 26 and over
Tretinoin-benzoyl peroxide (Twyneo)Age 26 and over
Acute migraine Agents​
Eletriptan (Relpax)Under age 18
Sumatriptan (Imitrex, Onzetra. Xsail, Zembrace Symtouch)Under age 18
Naratriptan (Amerge)Under age 18
Rizatriptan (Maxalt/ Maxalt MLT)Under age 6
Zolmitriptan (Zomig/Zomig ZMT)Under age 12
Almotriptan    Under age 12
Frovatriptan (Frova)Under age 18
Miscellaneous​
Auvi-Q 0.1mgAge 4 and over

n/an/a
656
  
10/1/2025Rx.01.302CommercialVanHorn, LynnseyQ2-2025
Resistant hуреrtеոsiοn is defined as a blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes taken at maximally tolerated doses and at appropriate dosing frequency, one of which should be a diuretic (the diuretic should be selected based upon kidney function). Patients with resistant hуреrtеnѕiоn are at high risk for adverse cardiovascular events and are more likely to have a secondary cause of high blood pressure, which may be at least in part reversible. By definition they require more aggressive medication treatment, as well as the potential use of specialized interventions, to control their high blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.

Aprocitentan is an ERA that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors. ET-1, via its receptors (ETA and ETB), mediates a variety of deleterious effects such as vasoconstriction, fibrosis, cell proliferation, and inflammation. In hypertension, ET-1 can cause endothelial dysfunction, vascular hypertrophy and remodeling, sympathetic activation, and increased aldosterone synthesis. 

TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. 

​The intent of this policy is to communicate the medical necessity criteria for aprocitentan (Tryvio™) as provided under the member's prescription drug benefit. 

INITIAL CRITERIA: Aprocitentan (Tryvio™) is medically necessary when ALL of the following are met:

  1. Diagnosis of treatment resistant hypertension; and
  2. Member has not achieved target blood pressure (e.g., systolic blood pressure [SBP] less than 130 mmHg) after treatment with all of the following antihypertensive medications from different classes for an adequate duration (minimum 4 weeks each) at a maximally tolerated dose:
    1. One of the following:
      1. Angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril); or
      2. Angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan); and
    2. Diuretic (e.g., hydrochlorothiazide, chlorthalidone); and
    3. Calcium channel blocker (e.g., amlodipine, nifedipine); and
    4. Mineralocorticoid receptor antagonist (MRA) [e.g., eplerenone, spironolactone]; and
  3. Provider attests other causes of hypertension have been ruled out (e.g., secondary causes [primary hyperaldosteronism], white coat effect, medication nonadherence); and
  4. Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program); and
  5. Requested drug will be used in combination with at least 3 antihypertensive medications from different classes; and
  6. Prescribed by or in consultation with a specialist experienced in the treatment of resistant hypertension (e.g., cardiologist, nephrologist)

 
Initial authorization duration: 2 years
 
REAUTHORIZATION CRITERIA: Aprocitentan (Tryvio™) is medically necessary when ALL of the following are met:

  1. Member demonstrates positive clinical response to therapy (e.g., systolic blood pressure [SBP] less than 130 mmHg); and
  2. Member continues to use Tryvio in combination with at least 3 antihypertensive medications from different classes and is adherent to therapy; and
  3. Requested drug will continue to be used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program)

 
Reauthorization duration: 2 years


WARNING: EMBRYO–FETAL TOXICITY 
See full prescribing information for complete boxed warning. 
  • TRYVIO can cause major birth defects if used by pregnant patients and is contraindicated in pregnancy. 
  • Patients who can become pregnant: Exclude pregnancy prior to initiation of treatment, monthly during treatment, and for one month after stopping TRYVIO.
  • Patients who can become pregnant: Use acceptable contraception prior to initiation of treatment, during treatment, and for one month after stopping TRYVIO. 
  • TRYVIO is only available through a restricted distribution program called the TRYVIO REMS. 

Brook RD, Townsend RR. Treatment of resistant hypertension. UpToDate. October 2024. Available at: https://www.uptodate.com. Accessed May 29, 2025.

TRYVIO™ (aprocitentan) [package insert]. Radnor, PA: Idorsia Pharmaceuticals US Inc. April 2024. Available from: https://www.idorsia.us/dam/jcr:d834ee09-2e6c-443d-b3ac-c111e38f0990/tryvio_pi.pdf. Accessed May 29, 2025. 
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Rx.01.33 Off Label Use
Brand NameGeneric Name
Tryvio™Aprocitentan

Tryvio™Aprocitentan
547
  
4/1/2025Rx.01.259CommercialVanHorn, LynnseyQ4-2024

The antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis include granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). These vasculitis are complex, immune-mediated disorders in which tissue injury results from the interplay of an initiating inflammatory event and a highly specific immune response. Part of this response is directed against previously shielded epitopes of neutrophil granule proteins, leading to high-titer autoantibodies known as ANCA. The production of ANCA is one of the hallmarks of the ANCA-associated vasculitis. ANCA are directed against antigens present primarily within the granules of neutrophils and monocytes; these autoantibodies produce tissue damage via interactions with primed neutrophils and endothelial cells.

Avacopan (Tavneos™) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. Avacopan does not eliminate glucocorticoid use.

Avacopan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. Avacopan blocks C5a-mediated neutrophil activation and migration. The precise mechanism by which avacopan exerts a therapeutic effect in patients with ANCA-associated vasculitis has not been definitively established.

The intent of this policy is to communicate the medical necessity criteria for Avacopan (Tavneos™) as provided under the member's prescription drug benefit. 


INITIAL CRITERIA: Avacopan (Tavneos™) is medically necessary when ALL of the following are met:

  1. Diagnosis of one of the following types of severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis:
    1. Granulomatosis with polyangiitis (GPA); or
    2. Microscopic polyangiitis (MPA); and
  2. Member is receiving concurrent immunosuppressant therapy with one of the following:
    1. Cyclophosphamide; or
    2. Rituximab; and
  3. One of the following:
    1. Member is concurrently on glucocorticoids (e.g., prednisone); or
    2. Inadequate response or inability to tolerate glucocorticoids (e.g., prednisone); and
  4. Member is 18 years of age or older; and
  5. Prescribed by or in consultation with one of the following:
    1. Nephrologist; or
    2. Pulmonologist; or
    3. Rheumatologist

Initial authorization duration: 6 months

REAUTHORIZATION CRITERIA: Avacopan (Tavneos™) is medically necessary when ALL of the following are met:

  1. Member does not show evidence of progressive disease while on therapy; and
  2. Member is receiving concurrent immunosuppressant therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab); and
  3. Prescribed by or in consultation with one of the following:
    1. Nephrologist; or
    2. Pulmonologist; or
    3. Rheumatologist

Reauthorization duration: 2 years


N/A

Pathogenesis of antineutrophil cytoplasmic autoantibody-associated vasculitis. UpToDate. October 2020. Available at: https://www.uptodate.com/contents/pathogenesis-of-antineutrophil-cytoplasmic-autoantibody-associated-vasculitis?search=antineutrophil%20cytoplasmic%20autoantibody%20associated%20vasculitis&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed December 15, 2024

Tavneos (avacopan) [package insert]. Cincinnati, OH. ChemoCentryx, Inc. Feburary 2022. Available at:

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7ea3c60a-45c7-44cc-afc2-d87fa53993c0&type=display. Accessed December 15, 2024

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​Rx.01.33 Off Label Use

Brand NameGeneric Name
Tavneos™Avacopan

Tavneos™Avacopan
677
  
10/1/2025Rx.01.6CommercialVanHorn, LynnseyQ2-2025
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 medically necessary when ALL of the following are met:

  1. Member is 7 years of age or older; and
  2. Diagnosis of cystic fibrosis; and
  3. Evidence of Pseudomonas aeruginosa in the lungs confirmed by culture; and
  4. Susceptibility results indicating that the Pseudomonas aeruginosa is sensitive to aztreonam; and
  5. FEV1 that is 25% to 75% of predicted; and
  6. Member is not colonized with Burkholderia cepacia

Initial authorization duration: 2 years

REAUTHORIZATION CRITERIA: Aztreonam (Cayston®) is medically necessary when ALL of the following are met:

  1. Diagnosis of cystic fibrosis; and
  2. Evidence of Pseudomonas aeruginosa in the lungs confirmed by culture; and
  3. Documentation of positive clinical response to therapy (i.e., improvement in lung function [forced expiratory volume in one second {FEV1}], decreased number of pulmonary exacerbations)

Reauthorization duration: 2 years

None
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 May 30, 2025.  

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 May 30, 2025.    

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 May 30, 2025. 

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 May 30, 2025. 

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Rx.01.33 Off-Label Use​



Brand NameGeneric Name
Cayston®Aztreonam

Cayston Aztreonam
600
  
7/1/2025Rx.01.225CommercialVanHorn, LynnseyQ1-2025

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 medically necessary when BOTH of the following are met:

  1. Member has a lower extremity diabetic neuropathic ulcer; and
  2. 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 medically necessary when ONE of the following is met:

  1. Documentation of lower extremity diabetic neuropathic ulcer at a different treatment site; or
  2. Documentation of continued need for treatment beyond 6 months

Reauthorization duration: 6 months

None

Pendsey, S. Understanding diabetic foot. Int J Diabetes Dev Ctries 2010; 30:75-9. Accessed February 21, 2025.

Armstrong, D., J de Asla, R. Management of diabetic foot ulcers. UpToDate. March 2023. Available from: https://www.uptodate.com/contents/management-of-diabetic-foot-ulcers?search=diabetic%20foot%20ulcer&source=search_result&selectedTitle=1~61&usage_type=default&display_rank=1. Accessed February 21, 2025.

Regranex® (becaplermin gel) [prescribing information]. Fort Worth, TX: Smith & Nephew, Inc. December 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd2c7d21-7b07-4ab3-8983-816ab3223771. Accessed February 21, 2025.

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Rx.01.33 Off Label Use 
Brand nameGeneric name
Regranex®Becaplermin

Regranex®Becaplermin
601
  
7/1/2025Rx.01.203CommercialVanHorn, LynnseyQ1-2025

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 medically necessary when ALL of the following are met:

  1. Diagnosis of active systemic lupus erythematosus; and
  2. Autoantibody positive (i.e., 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
  3. Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials [e.g., hydroxychloroquine], corticosteroids, NSAIDs, or immunosuppressants); and
  4. Prescribed by or in consultation with a rheumatologist; and
  5. Member is 5 years of age or older

Initial Authorization duration: 6 months

REAUTHORIZATION CRITERIA: Belimumab (Benlysta®) is medically necessary when there is documentation of positive clinical response to therapy.

Reauthorization duration: 2 years

Lupus Nephritis
INITIAL CRITERIA Belimumab (Benlysta®) is medically necessary when ALL of the following are met:

  1. Member has active lupus nephritis confirmed by kidney biopsy; and
  2. Member is receiving standard therapy for lupus nephritis (e.g. corticosteroids, immunosuppressants, azathioprine); and
  3. Prescribed by or in consultation with a rheumatologist or nephrologist; and
  4. Member is 5 years of age or older

INITIAL CRITERIA Voclosporin (Lupkynis™) is medically necessary when ALL of the following are met:

  1. Diagnosis of active lupus nephritis; and
  2. Member is 18 years of age or older; and
  3. Used in combination with mycophenolate mofetil and corticosteroids; and
  4. Prescribed by or in consultation with nephrologist or rheumatologist 

Initial Authorization duration: 6 months

REAUTHORIZATION CRITERIA: Belimumab (Benlysta®) or Voclosporin (Lupkynis™) is medically necessary 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 February 21, 2025.

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 February 21, 2025.

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 February 21, 2025.

Lupus facts and statistics. Lupus Foundation of America Web Site. https://resources.lupus.org/entry/facts-and-statistics. Published 2017. Accessed February 21, 2025.

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 February 21, 2025.

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Rx.01.33 Off-Label Use

Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit


Brand NameGeneric Name
Benlysta®belimumab
Lupkynis™voclosporin

N/AN/A
488
  
1/1/2025Rx.01.256CommercialVanHorn, LynnseyQ3-2024

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:

  1. Diagnosis of chronic graft-versus-host disease; and
  2. Member is 12 years of age or older; and
  3. Inadequate response or inability to tolerate two or more lines of systemic therapy (e.g., corticosteroids, mycophenolate, etc.); and
  4. Prescribed by or in consultation with one of the following:
    1. Hematologist; or
    2. Oncologist; or
    3. 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


N/A

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.

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​Rx.01.33 Off Label Use
Brand NameGeneric Name
RezurockTMBelumosudil

Rezurock™Belumosudil
637
  
7/1/2025Rx.01.294CommercialVanHorn, LynnseyQ1-2025
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 medically necessary when ALL of the following are met:

  1. Diagnosis of one of the following:
    1. Dystrophic epidermolysis bullosa (DEB); or
    2. Junctional epidermolysis bullosa (JEB); and
  2. Disease is confirmed by one of the following:
    1. Genetic testing confirms mutation in one of the following genes:
      1. For Dystrophic epidermolysis bullosa (DEB), collagen type VII (COL7A1); or
      2. For Junctional epidermolysis bullosa (JEB), one of the following:
        1. ITGA6; or
        2. ITGB4; or
        3. Collagen type XVII (COL17A1); or
        4. LAMA3; or
        5. LAMB3; or
        6. LAMC2; or
        7. ITGA3; or
        8. LAMA3A; or
    2. Skin biopsy; and
  3. Member is 6 months of age or older; and
  4. Medication will be used for the treatment of wounds that require healing; and
  5. DEB or JEB associated wounds are present for at least 21 days; and
  6. Member does not have signs of infection for wound being treated; and
  7. Member has no evidence or history of basal or squamous cell carcinoma for wound being treated; and
  8. Member does not have history of stem cell transplant or gene therapy (e.g., Vyjuvek) for the treatment of epidermolysis bullosa; and
  9. Standard wound care management not adequate in healing wounds (e.g., daily wound dressings, pain management, controlling infections); and
  10. 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 medically necessary when ALL of the following are met:

  1. Member demonstrates positive clinical response to therapy as evidenced by wound is healing but not completely closed; and
  2. Member does not have signs of infection for wound being treated; and
  3. Member has no evidence or history of basal or squamous cell carcinoma for wound being treated; and
  4. Prescribed by or in consultation with a dermatologist with expertise in the treatment of epidermolysis bullosa

 
Reauthorization duration: 6 months


None

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 March 3, 2025.

Murrell DF. Overview of the management of epidermolysis bullosa. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed March 3, 2025.

Filsuvez® (Birch triterpenes) [package insert]. Wahlstedt, Germany: Lichtenheldt GmbH Pharmazeutische Fabrik. May 2024. Available at: https://resources.chiesiusa.com/Filsuvez/FILSUVEZ_PI.pdf. Accessed March 3, 2025.

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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

N/AN/A
678
  
10/1/2025Rx.01.208CommercialVanHorn, LynnseyQ2-2025

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:

  1. 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. 
  2. 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. 
  3. In combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
  4. 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 medically necessary when ALL of the following are met:

  1. Diagnosis of relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP) for greater than 6 months; and
  2. ONE of the following:
    1. For eltrombopag olamine (Promacta®) only, member is 1 year of age or older; or
    2. For eltrombopag choline (Alvaiz™) only, member is 6 years of age or older; and
  3. Baseline platelet count is less than 30,000/mcL; and
  4. Insufficient response to corticosteroids, immunoglobulins, or splenectomy; and
  5. Prescribed by or in consultation with a hematologist/oncologist ; and
  6. Member's degree of thrombocytopenia and clinical condition increase the risk of bleeding
INITIAL CRITERIA: Fostamatinib (Tavalisse™) is medically necessary when all of the following are met:
  1. Diagnosis of relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP); and
  2. Baseline platelet count is less than 30,000/mcL; and
  3. Member's degree of thrombocytopenia and clinical condition increase the risk of bleeding; and
  4. Documentation of an inadequate response or inability to tolerate ONE of the following:
    1. Corticosteroids; or 
    2. Immunoglobulins; or
    3. Splenectomy; or
    4. Thrombopoietin receptor agonists (e.g., Nplate®, Promacta®); or
    5. Rituximab; and
  5. Prescribed by or in consultation with a hematologist/oncologist; and
  6. Member is 18 years of age or older

INITIAL CRITERIA: Avatrombopag (Doptelet®) is medically necessary when ALL of the following are met:

  1. Diagnosis of relapsed/refractory chronic immune thrombocytopenia purpura (ITP); and
  2. Baseline platelet count is less than 30,000/mcL; and
  3. Inadequate response or inability to tolerate ONE of the following: 
    1. Corticosteroids; or
    2. immunoglobulins; or
    3. splenectomy; or
    4. Rituxan (rituximab); and
  4. Member's degree of thrombocytopenia and clinical condition increase the risk of bleeding; and
  5. Prescribed by or in consultation with a hematologist/oncologist; and
  6. 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 medically necessary when ALL of the following are met:

  1. Diagnosis of chronic immune (idiopathic) thrombocytopenic purpura; and
  2. 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
  3. Prescribed by or in consultation with a hematologist/oncologist

Continuation authorization duration: 2 years

First Line Treatment for Severe Aplastic anemia
INITIAL CRITERIA: Eltrombopag olamine (Promacta®) is medically necessary when ALL of the following are met:

  1. Diagnosis of severe aplastic anemia; and
  2. Member is 2 years of age or older; and
  3. Used as first-line treatment (i.e., member has not received prior immunosuppressive therapy with any equine antithymocyte globulin plus cyclosporine, alemtuzumab, or high dose cyclophosphamide); and
  4. TWO of the following:
    1. Absolute neutrophil count < 500/mcL
    2. Platelet count < 20,000/mcL
    3. Absolute reticulocyte count < 60,000/mcL; and
  5. Used in combination with standard immunosuppressive therapy (e.g., Atgam [antithymocyte globulin equine] and cyclosporine); and
  6. Prescribed by or in consultation with a hematologist/oncologist

Approval duration: 6 months
 
Refractory Severe Aplastic Anemia

INITIAL CRITERIA: Eltrombopag olamine (Promacta®), eltrombopag choline (Alvaiz™) is  medically necessary when ALL of the following are met:

  1. Diagnosis of refractory severe aplastic anemia; and
  2. Member is 18 years of age or older; and
  3. Inadequate response or inability to tolerate immunosuppressive therapy with antithymocyte globulin (ATG) and cyclosporine; and
  4. Member has thrombocytopenia defined as platelet count less than 30,000/mcL; and
  5. Prescribed by or in consultation with a hematologist/oncologist

Initial authorization duration: 16 weeks
 
CONTINUATION CRITERIA: Eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) is medically necessary when ALL of the following are met:

  1. Diagnosis of refractory severe aplastic anemia; and
  2. Documentation of a positive clinical response to therapy as evidenced by an increase in platelet count; and
  3. 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 medically necessary when ALL of the following are met:

  1. Diagnosis of thrombocytopenia associated with hepatitis C; and
  2. Member is 18 years of age or older; and
  3. ONE of the following:
    1. Member is planning to initiate and maintain interferon-based therapy; or
    2. Member is currently on optimal interferon-based therapy; and
    3. Prescribed by or in consultation with one of the following:
      1. Hematologist/oncologist
      2. Gastroenterologist
      3. Hepatologist
      4. Infectious disease specialist
      5. HIV specialist
Initial authorization duration: 48 weeks

CONTINUATION CRITERIA: Eltrombopag olamine (Promacta®) or eltrombopag (Alvaiz®) is medically necessary when ALL of the following are met:
  1. Diagnosis of thrombocytopenia associated with hepatitis C; and
  2. ONE of the following:
    1. For members that started treatment with eltrombopag olamine (Promacta®) or eltrombopag choline (Alvaiz™) prior to initiation of treatment with interferon, BOTH of the following:
      1. Member is currently on antiviral interferon therapy for treatment of chronic hepatitis C, and
      2. 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
    2. 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
  3. Prescribed by or in consultation with one of the following:
    1. Hematologist/oncologist
    2. Gastroenterologist
    3. Hepatologist
    4. Infectious disease specialist
    5. HIV specialist
Continuation authorization duration: 48 weeks

Thrombocytopenia in Chronic Liver Disease Prior to Planned Procedure

Lusutrombopag (Mulpleta®) or Avatrombopag (Doptelet®) is medically necessary when ALL of the following are met:
  1. Diagnosis of thrombocytopenia; and
  2. Member has chronic liver disease; and
  3. Member is scheduled to undergo a procedure; and
  4. Baseline platelet count is less than 50,000/mcL; and
  5. Member is 18 years of age or older; and
  6. 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 May 30, 2025.

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 May 30, 2025.

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 May 30, 2025.

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 May 30, 2025.

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 May 30, 2025.

Shah, N. MD, Intagliata, N, MD. March 2024. Hemostatic abnormalities in patients with liver disease. UpToDate. Access May 30, 2025.

"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 May 30, 2025.

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 May 30, 2025.

126/5/20256/4/202610/1/2025 1:21 AMNo presence informationsrv_ppsgw_P
Rx.01.33 Off Label Use
Brand NameGeneric Name
Promacta®Eltrombopag olamine
Tavalisse™fostamatinib
Doptelet®avatrombopag
Mulpleta®lusutrombopag
Alvaiz™eltrombopag choline

N/AN/A
477
  
10/1/2024Rx.01.293CommercialOyenusi, OluwadamilolaQ2-2024
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:

  1. Diagnosis of eosinophilic esophagitis (EoE); and
  2. Member has symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, heartburn, abdominal pain); and
  3. Member has at least 15 intraepithelial eosinophils per high power field (HPF); and
  4. Other causes of esophageal eosinophilia have been ruled out; and
  5. Member is 11 years of age or older; and
  6. Inadequate response or inability to tolerate a minimum 8-week duration of both of the following:
    1. Proton pump inhibitor (e.g., pantoprazole, omeprazole); and
    2. Topical (esophageal) corticosteroid (e.g., budesonide, fluticasone); and
  7. Prescribed by or in consultation with one of the following:
    1. Allergist/immunologist; or
    2. Gastroenterologist

Authorization duration: 12 weeks


N/A
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.
17/1/20246/6/202510/1/2024 1:19 AMNo presence informationsrv_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
602
  
7/1/2025Rx.01.262CommercialVanHorn, LynnseyQ1-2025

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 medically necessary when ALL of the following are met:

  1. Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy; and
  2. Member is 18 years of age or older; and
  3. 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
  4. Used to reduce proteinuria; and
  5. Estimated glomerular filtration rate (eGFR) greater than or equal to 35 ml/min/1.73 m2; and
  6. One of the following:
    1. Member has been on a minimum 90-day trial of maximally tolerated dose and will continue to receive therapy with one of the following:
      1. An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril); or
      2. An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan); or
    2. Member is unable to tolerate BOTH ACE inhibitors and ARBs; and
  7. Inadequate response or inability to tolerate another glucocorticoid (e.g., prednisone, methylprednisolone); and
  8. Prescribed by or in consultation with a nephrologist

Authorization duration: 9 months

None

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 February 21, 2025. 

Cattran DC. IgA nephropathy: Treatment and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 21, 2025. 

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​Rx.01.33 Off Label Use​


Brand NameGeneric Name
Tarpeyo™Budesonide

Tarpeyo™Budesonide
489
  
1/1/2025Rx.01.10CommercialVanHorn, LynnseyQ3-2024

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:

  1. Diagnosis of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency; and 
  2. Medication will be used as adjunctive therapy to other ammonia lowering therapies (e.g., protein restriction, ammonia scavengers, dialysis) 
  3. 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:

  1. Diagnosis of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA); and
  2. Medication will be used as adjunctive therapy to other ammonia lowering therapies (e.g., intravenous glucose, insulin, protein restriction, dialysis); and
  3. Patient's plasma ammonia level is greater than or equal to 50 micromol/L; and
  4. Medication will be used for a maximum duration of 7 days; and
  5. 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:

  1. Diagnosis of chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency; and
  2. NAGS deficiency has been confirmed by genetic/mutational analysis; and
  3. Medication will be used as maintenance therapy; and
  4. 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


N/A

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.


159/12/20249/11/20251/1/2025 1:12 AMNo presence informationsrv_ppsgw_P
Off-Labe Use Rx01.33
Brand NameGeneric Name
Carbaglu®Carglumic Acid

Carbaglu®Carglumic acid
679
  
10/1/2025Rx.01.217CommercialVanHorn, LynnseyQ2-2025
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 medically necessary when ALL of the following are met:

  1. Diagnosis of Stage 2 or 3 neurotrophic keratitis; and
  2. 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
  3. Prescribed by or in consultation with an ophthalmologist or optometrist; and
  4. Submission of chart documentation indicating treatment of left eye, right eye, or both; and
  5. Member will not exceed 8 weeks of Oxervate therapy per affected eye(s)

Initial authorization duration: 8 weeks

REAUTHORIZATION CRITERIA Cenegermin-bkbj (Oxervate™) is medically necessary when ALL of the following are met:

  1. Submission of chart documentation indicating treatment of left eye, right eye, or both; and
  2. One of the following:
    1. Member has received less than or equal to 8 weeks of therapy (one course of therapy) per affected eye(s); and
    2. 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
  3. Documentation of clinical response to prior Oxervate™ therapy; and
  4. Member will not exceed a total of 16 weeks of Oxervate™ therapy per affected eye(s); and
  5. Prescribed by or in consultation with an ophthalmologist or optometrist

Reauthorization duration: One 8-week approval
Lifetime limit: 16 weeks of therapy per affected eye


None

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 May 30, 2025.

Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2019; 66:107-131. Accessed May 30, 2025.

Oxervate® (cenegermin-bkbj) [prescribing information]. Boston, MA: Dompe U.S. Inc. October 2023. Available at:  https://oxervate.com/pdf/PrescribingInformation.pdf. Accessed May 30, 2025.

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 May 30, 2025.

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 May 30, 2025.

Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratisis. Clin Ophthalmol. 2014; 8:571-579. Accessed May 30, 2025.

Semeraro F, Forbice E, Romano V, et al. Neurotrophic keratitis. Opthalmologica. 2014;231(4):191-197. Accessed May 30, 2025.

Versura P, Giannaccare G, Pellegrini M, Sebastiani S, Campos EC. Neurotrophic keratitis: current challenges and future prospects. Eye Brain. 2018; 10:37-45. Accessed May 30, 2025.

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Rx.01.33 Off-Label Use
Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit


Brand NameGeneric Name
Oxervate™cenegermin-bkbj

OxervateCenegermin-bkbj
490
  
1/1/2025Rx.01.22CommercialVanHorn, LynnseyQ3-2024
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:

  1. Diagnosis of chronic iron overload due to blood transfusions; and
  2. Member is 2 years of age or older; and
  3. Serum ferritin levels are consistently greater than 1000 mcg/L (as demonstrated with at least two lab values within two months prior to treatment)
  4. 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:

  1. Diagnosis of transfusional iron overload due to Sickle Cell disease or other transfusion-dependent anemia; and
  2. Member is 3 years of age or older; and
  3. Inadequate response or inability to tolerate one of the following chelation therapy:
    1. Generic deferoxamine; or
    2. generic deferasirox; and
  4. For Brand Ferriprox tablets only, Inadequate response or inability to tolerate generic deferiprone tablets; and
  5. 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:

  1. Diagnosis of chronic iron overload in Non-Transfusion-Dependent Thalassemia Syndromes; and
  2. Member is 10 years of age or older; and
  3. 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:

  1. Diagnosis of transfusional iron overload due to Thalassemia Syndrome; and
  2. Member is 3 years of age or older; and
  3. Inadequate response or inability to tolerate one of the following chelation therapy:
    1. Generic deferoxamine; or
    2. Generic deferasirox; and
  4. For Brand Ferriprox tablets only, Inadequate response or inability to tolerate generic deferiprone tablets; and
  5. 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.

Exjade (deferasirox) [package insert]. East Hanover NJ. Novartis Pharmaceuticals Corporation.  Revised July 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3495a70c-870c-4968-940e-8baea152cf85&type=display. Accessed October 10, 2024.

Ferriprox (deferiprone) [package insert]. Rockville MD. ApoPharma USA, Inc.  Revised  May 2020.  Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=97f7bfcb-8666-464c-87b6-9621ceca5ee2&type=display. Accessed October 10, 2024.

 Gilroy RK. Wilson Disease. Available at: http://emedicine.medscape.com/article/183456-overview#a1. Accessed October 10, 2024.

Jadenu (deferasirox) [package insert]. East Hanover NJ. Novartis Pharmaceuticals Corporation. Revised July 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fee89140-fff1-4443-9f42-24ac004fcda1. Accessed October 10, 2024.

 Mir M. Transfusion induced iron overload. Available at: http://emedicine.medscape.com/article/1389732-overview. Accessed October 10, 2024.

Musallam KM, Rivella S, Vichinsky E, Rachmilewitz. Non-transfusion-dependent thalassemias. Haematologica. June 2013;98:833-844. DOI: 10.3324/haematol.2012.066845
169/12/20249/11/20251/1/2025 1:12 AMNo presence informationsrv_ppsgw_P
Off-Label Use policy Rx.01.33
Brand NameGeneric Name
ExjadeDeferasirox
JadenuDeferasirox
Ferriprox
Deferiprone

Exjade®/Jadenu® and Ferriprox®deferasirox and deferiprone
652
  
7/1/2025Rx.01.131CommercialVanHorn, LynnseyQ2-2025
Lomitapide a synthetic lipid-lowering agent, directly binds and inhibits microsomal triglyceride transfer protein, which resides in the lumen of the endoplasmic reticulum, thereby preventing the assembly of apo B-containing lipoproteins in enterocytes and hepatocytes. This inhibits the synthesis of chylomicrons and very low-density lipoprotein (VLDL). The inhibition of the synthesis of VLDL leads to reduced levels of plasma LDL-C.

Lomitapide (Juxtapid®) is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Proprotein convertase subtilisin/ kexin type 9 (PCSK9) is a serine protease synthesized primarily by the liver and intestines.  PCSK9 promotes the degradation of low density lipoprotein (LDL) receptors, thus preventing them from being recycled back to the plasma membrane where they can bind more LDL. Inhibitors of PCSK9 increase recycling of LDL receptors which in turn increases the capacity to remove LDL cholesterol (LDL-C) from the blood. These agents are monoclonal antibodies administered subcutaneously.

Alirocumab (Praluent®) is indicated:
  • To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
  • As adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
  • As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. 
  • As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.
Evolocumab (Repatha®) is indicated:
  • in adults with established cardiovascular disease (CVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
  • As adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
  • As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C. 
  • As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
According to current guidelines, HMG-CoA reductase inhibitors (statins) are the mainstay of pharmacologic therapy for treating elevated LDL-C for both primary and secondary prevention of atherosclerotic cardiovascular disease.  Lifestyle modifications are a critical component of treating elevated LDL-C and should be used in conjunction with pharmacologic therapy.  

Clinical trials of PCSK9 inhibitors demonstrated reductions in LDL-C approximately 50-60%.  Reauthorization criteria will include a reduction from baseline of 25% or greater, which will assess adherence with the medication.

Bempedoic acid (Nexletol™) is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver.  ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway.  Bempedoic ​acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively.  ACSVL1 is expressed primarily in the liver.  Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.

Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine.  The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols.  Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver.  This causes a reduction of hepatic cholesterol stores and an increase in LDL receptors, resulting in clearance of cholesterol from the blood.

Bempedoic acid (Nexletol™) and bempedoic acid/ezetimibe (Nexlizet™) is indicated: 
  • To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
    • established cardiovascular disease (CVD), or
    • a high risk for a CVD event but without established CVD
  • As an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant  LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)
The intent of this policy is to communicate the medical necessity criteria for lomitapide (Juxtapid®), alirocumab (Praluent®), evolocumab (Repatha®), bempedoic acid (Nexletol™), and bempedoic acid/ezetimibe (Nexlizet™) as provided under the member's prescription drug benefit.

Hypercholesterolemia

INITIAL CRITERIA: Alirocumab (Praluent®) is medically necessary when ALL of the following are met:

  1. Diagnosis of ONE of the following:
    1. Hyperlipidemia; or
    2. Heterozygous familial hypercholesterolemia (HeFH) and member is 10 years of age or older; or
    3. Atherosclerotic cardiovascular disease (ASCVD) as diagnosed by either stress test, angiography, atherosclerotic event (e.g., MI, angina, stroke, claudication, carotid stenosis) or arterial intervention for atherosclerotic diseases (e.g., coronary, peripheral, carotid); and
  2. ONE of the following:
    1. While on maximally tolerated statin therapy within the last 120 days:
      1. Member has LDL-C greater than or equal to 70 mg/dL with atherosclerotic cardiovascular disease (ASCVD); or
      2. Member has LDL-C greater than or equal to 100mg/dL without atherosclerotic cardiovascular disease (ASCVD); or
      3. Member requires greater than or equal to 25% LDL-C reduction to achieve goal; or
    2. BOTH of the following:
      1. Member has been receiving PCSK9 therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe); and
      2. LDL-C values drawn within the past 12 months while on maximally tolerated lipid lower therapy is within normal limits; and
  3. ONE of the following: 
    1. Member has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy; or
    2. Member has rhabdomyolysis or symptoms with creatine kinase (CK) exceeding 10 times the upper limit of normal (ULN) on any statin; or
    3. ONE of the following with TWO statins:
      1. Myalgia (no CK elevation); or
      2. Myositis (CK less than 10 times ULN); or
      3. Hepatotoxicity from statin use (increase AST/ALT exceeding 3 times ULN); or
    4. Liver disease documented by Child Pugh A or worse or AST/ALT exceeding 3 times ULN for at least 6 weeks; or
    5. Member has an FDA labeled contraindication to all statins; and
  4. Inadequate response or inability to tolerate evolocumab (Repatha®) for members 10 years of age or older

Initial authorization duration: 6 months.

REAUTHORIZATION CRITERIA: Alirocumab (Praluent®) is medically necessary when all of the following are met:

  1. Member demonstrates positive clinical response to therapy as evidence by a reduction in LDL-C levels from baseline; and
  2. ONE of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose; or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe); and
  3. Inadequate response or inability tolerate evolocumab (Repatha®) for members 10 years of age or older
Reauthorization duration: 12 months

INITIAL CRITERIA: Evolocumab (Repatha®) is medically necessary when ALL of the following are met:
  1. Diagnosis of ONE of the following:
    1. Hyperlipidemia; or
    2. Heterozygous familial hypercholesterolemia (HeFH) and member is 10 years of age or older; or
    3. Atherosclerotic cardiovascular disease (ASCVD) as diagnosed by either stress test, angiography, atherosclerotic event (e.g., MI, angina, stroke, claudication, carotid stenosis) or arterial intervention for atherosclerotic disease (e.g., coronary, peripheral, carotid); and
  2. ONE of the following:
    1. While on maximally tolerated statin therapy within the last 120 days:
      1. Member has LDL-C greater than or equal to 70 mg/dL with atherosclerotic cardiovascular disease (ASCVD); or
      2. Member has LDL-C greater than or equal to 100mg/dL without atherosclerotic cardiovascular disease (ASCVD); or
      3. Member requires greater than or equal to 25% LDL-C reduction to achieve goal; or
    2. BOTH of the following:
      1. Member has been receiving PCSK9 therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe); and
      2. LDL-C values drawn within the past 12 months while on maximally tolerated lipid lowering therapy is within normal limits; and
  3. ONE of the following:
    1. Member has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy; or
    2. Member had rhabdomyolysis or symptoms with creatine kinase (CK) exceeding 10 times the upper limit of normal (ULN) on any statin; or
    3. ONE of the following with TWO statins:
      1. Myalgia (no CK elevation); or
      2. Myositis (CK less than 10 times ULN; or
      3. Hepatotoxicity from statin use (increased AST/ALT exceeding 3 times ULN); OR
    4. Liver disease documented by Child Pugh A or worse OR AST/ALT exceeding 3 times ULN for at least 6 weeks; or
    5. Member has an FDA labeled contraindication to all statins

Initial Authorization duration: 6 months

REAUTHORIZATION CRITERIA:  Evolocumab (Repatha®) is medically necessary when all of the following are met:

  1. Member demonstrates positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline; and
  2. One of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose; or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe)
Reauthorization duration: 12 months

INITIAL CRITERIA: Bempedoic acid (Nexletol™), bempedoic acid/ezetimibe (Nexlizet™) is medically necessary when ALL of the following are met:
  1. ONE of the following:
    1. Heterozygous familial hypercholesterolemia (HeFH); or
    2. Primary hyperlipidemia; and
  2. One of the following:
    1. LDL-C greater than or equal to 55mg/dL with atherosclerotic cardiovascular disease (ASCVD) while on maximally tolerate statin therapy within the last 120 days; or
    2. LDL-C greater than or equal to 100mg/dL without atherosclerotic cardiovascular disease (ASCVD) while on maximally tolerate statin therapy within the last 120 days; or
    3. Inability to tolerate statin therapy as documented by ONE of the following:
      1. Member has rhabdomyolysis or symptoms with creatine kinase (CK) exceeding 10 times the upper limit of normal (ULN) on any statin; or
      2. ONE of the following with TWO statins:
        1. Myalgia (no CK elevation); or
        2. Myositis (CK less than 10 times ULN); or
        3. Hepatotoxicity from statin use (increase AST/ALT exceeding 3 times ULN); or
      3. Liver disease documented by Child Pugh A or worse or AST/ALT exceeding 3 times ULN for at least 6 weeks; or
      4. Member has an FDA labeled contraindication to all statins

Initial Authorization duration: 6 months

REAUTHORIZATION CRITERIA: Bempedoic acid (Nexletol™), Bempedoic acid/ezetimibe (Nexlizet™) is medically necessary when member demonstrates positive clinical response to therapy (e.g., reduction in LDL-C levels)

Reauthorization duration: 12 months

Homozygous Familial Hypercholesterolemia (HoFH)
INITIAL CRITERIA: Lomitapide (Juxtapid®) is medically necessary when ALL of the following are met:
  1. Diagnosis of Homozygous Familial Hypercholesterolemia (HoFH); and
  2. Used as an adjunct to lipid lowering treatments and a low-fat diet with ONE of the following:
    1. Genetic confirmation of 2 mutant alleles at the LDL receptor, Apo B, PCSK9, or LDL receptor adaptor protein 1 (i.e. LDLRAP1 or ARH); or
    2. Untreated LDL-C > 500mg/dL or treated LDL cholesterol ≥ 300mg/dL with either of the following:
      1. Cutaneous or tendinous xanthoma prior to 10 years of age, or
      2. Elevated LDL cholesterol prior to lipid-lowering therapy consistent with HeFH in both parents; and
  3. ONE of the following:
    1. Inadequate response to one of the following medications in combination with ezetimibe:
      1. Simvastatin (daily doses ≥ 40mg); or
      2. Atorvastatin (daily doses ≥ 20mg); or
      3. Rosuvastatin (daily doses ≥ 10mg); or
    2. Member has experience ONE of the following:
      1. Rhabdomyolysis or muscle symptoms with creatine kinase (CK) elevations > 10 times upper limit of normal (ULN) on any statin; or
      2. Myalgia (muscle symptoms without CK elevations) or myositis (muscle symptoms with CK elevations < 10 times ULN) with TWO statins; and
  4. Inadequate response or inability to tolerate evolocumab (Repatha®); and
  5. Not used in combination with a PCSK9 inhibitor; and
  6. Prescribed by or in consultation with one of the following:
    1. Cardiologist; or
    2. Endocrinologist; or
    3. Lipid specialist
Initial authorization duration: 6 months

REAUTHORIZATION CRITERIA: Lomitapide (Juxtapid®) is medically necessary when ALL of the following are met:
  1. One of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statin, ezetimibe); or
    2. Member has an inability to take other lipid-lowering therapy (e.g., statin, ezetimibe); and
  2. Reduction in LDL-C of at least 25% from baseline while on therapy; and
  3. Prescribed by or in consultation with one of the following:
    1. Cardiologist; or
    2. Endocrinologist; or
    3. Lipid specialist; and
  4. Not used in combination with a PCSK9 inhibitor
Reauthorization duration: 12 months

INITIAL CRITERIA: Alirocumab (Praluent®) is medically necessary when ALL of the following are met:
  1. Diagnosis of homozygous familial hypercholesterolemia (HoFH) and one of the following:
    1. Genetic confirmation of 2 mutations in the LDL receptor, ApoB, PCSK9, or LDL receptor adaptor protein 1 (i.e., LDLRAP1 or ARH); or
    2. Untreated LDL-C >400mg/dL with either of the following:
      1. Cutaneous or tendinous xanthoma prior to 10 years of age; or 
      2. Elevated LDL cholesterol prior to lipid-lowering therapy consistent with HeFH in both parents; and
  2. ONE of the following:
    1. Member is receiving other lipid-lowering therapy (e.g., statin, ezetimibe); or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe); and
  3. Member is 10 years of age or older; and
  4. Inadequate response or inability to tolerate evolocumab (Repatha®)

Initial authorization duration: 6 months

REAUTHORIZATION CRITERIA: Alirocumab (Praluent®) is medically necessary when all of the following are met:

  1. Member demonstrates positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline; and
  2. One of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose; or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe); and
  3. Inadequate response or inability to tolerate evolocumab (Repatha®)
Reauthorization duration: 12 months

INITIAL CRITERIA: Evolocumab (Repatha®) is medically necessary when ALL of the following are met:
  1. Diagnosis of Homozygous familial hypercholesterolemia (HoFH) and one of the following:
    1. Genetic confirmation of 2 mutations in the LDL receptor, ApoB, PCSK9, or LDL receptor adaptor protein 1 (i.e., LDLRAP1 or ARH); or
    2. Untreated LDL-C >400mg/dL with either of the following:
      1. Cutaneous or tendinous xanthoma prior to 10 years of age; or 
      2. Elevated LDL cholesterol prior to lipid-lowering therapy consistent with HeFH in both parents; and
  2. ONE of the following:
    1. Member is receiving other lipid-lowering therapy (e.g., statin, ezetimibe); or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe); and
  3. Member is 10 years of age or older
Initial authorization duration: 6 months

REAUTHORIZATION CRITERIA: Evolocumab (Repatha®) is medically necessary when all of the following are met:
  1. Member demonstrates positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline; and
  2. One of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose; or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe)
Reauthorization duration: 12 months

Established cardiovascular disease (CVD) or high risk for a CVD event but without established CVD
INITIAL CRITERIA: Bempedoic acid (Nexletol™), bempedoic acid/ezetimibe (Nexlizet™) is medically necessary when ALL of the following are met:
  1. ONE of the following:
    1. Member has established cardiovascular disease (CVD) (e.g., coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease); or
    2. Member is at high risk for a CVD event but without established CVD [e.g., diabetes mellitus (type 1 or type 2) in females over 65 years of age or males over 60 years of age]; and
  2. One of the following:
    1. LDL-C greater than or equal to 55 mg/dL with atherosclerotic cardiovascular disease (ASCVD) while on maximally tolerate statin therapy within the last 120 days; or
    2. LDL-C greater than or equal to 100 mg/dL without ASCVD while on maximally tolerate statin therapy within the last 120 days; and
    3. Inability to tolerate statin therapy as documented by ONE of the following:
      1. Member has rhabdomyolysis or symptoms with creatine kinase (CK) exceeding 10 times the upper limit of normal (ULN) on any statin; or
      2. ONE of the following with TWO statins:
        1. Myalgia (no CK elevation); or
        2. Myositis (CK less than 10 times ULN); or
        3. Hepatotoxicity from statin use (increase AST/ALT exceeding 3 times ULN); or
      3. Liver disease documented by Child Pugh A or worse or AST/ALT exceeding 3 times ULN for at least 6 weeks; or
      4. Member has an FDA labeled contraindication to all statins 

Initial Authorization duration: 6 months

REAUTHORIZATION CRITERIA: Bempedoic acid (Nexletol™), Bempedoic acid/ezetimibe (Nexlizet™) is medically necessary when member demonstrates positive clinical response to therapy (e.g., reduction in LDL-C levels)

Reauthorization duration: 12 months
JUXTAPID® (lomitapide): WARNING: RISK OF HEPATOTOXICITY

JUXTAPID can cause elevations in transaminases. 
  • Measure alanine and aspartate aminotransferases (ALT, AST), alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended.
  • During treatment, adjust the dose of JUXTAPID if the ALT or AST is ≥3 times the upper limit of normal (ULN).
  • Discontinue JUXTAPID for clinically significant liver toxicity. 
JUXTAPID increases hepatic fat (hepatic steatosis) with or without concomitant increases in transaminases. 
  • Hepatic steatosis associated with JUXTAPID may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.
Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program called the JUXTAPID REMS Program. Prescribe JUXTAPID only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.

Farnier M, Bruckert E. Severe familial hypercholesterolemia: Current and future management. Arch Cardiovasc Dis. 2012 Dec; 105(12):656-65. Accessed May 30, 2025.

Goldberg AC, Hopkins PN, Toth PP, et al. Familial hypercholesterolemia: screening, diagnosis, and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidology. 2011;5:S1-S8. Accessed May 30, 2025.

Grundy SM, Cleeman JI, Merz NB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004; 110:227-39. Accessed May 30, 2025.

Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for the patient-centered management of dyslipidemia: Part 1- full report. J Clin Lipidology. 2015;9:129-69. Accessed May 30, 2025.

Juxtapid® (lomitapide) [prescribing information.] Cambridge, MA. Aegerion Pharmaceuticals. September 2020. Available at: http://juxtapidpro.com/prescribing-information. Accessed May 30, 2025.

Raal FJ, Santos RD. Homozygous familial hypercholesterolemia: current perspectives on diagnosis and treatment. Atherosclerosis. 2012 Aug; 223(2):262-8. Accessed May 30, 2025.

Grundy SM, Stone NJ, Bailey AL, Yeboah J, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018. Available from: https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000624. Accessed May 30, 2025.

Visser ME, Witztum JL, Stroes ES, et al. Antisense oligonucleotides for the treatment of dyslipidaemia. Eur Heart J. 2012 Jun; 33(12):1451-8. doi: 10.1093/eurheartj/ehs084. Epub 2012 May 24.

Lambert G, Sjouke B, Choque B, Kastelein JJP, Hovingh GK. The PCSK9 decade. J Lipid Res. 2012; 53(12): 2515-24. DOI: 10.1194/jlr.R026658. Accessed May 30, 2025.

Farnier M. PCSK9: From discovery to therapeutic applications. Arch Cardiovascular Dis. 2014; 107: 58-66. DOI: 10.1016/j.acvd.2013.10.007. Accessed May 30, 2025.

Goldberg AC, Hopkins PN, Toth PP, et al. Familial hypercholesterolemia: screening, diagnosis, and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidology. 2011;5:S1-S8. Accessed May 30, 2025

Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for the patient-centered management of dyslipidemia: Part 1- full report. J Clin Lipidology. 2015;9:129-69. Accessed May 30, 2025.

Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly Jr DD, DePalma SM, Minissian, MB, Orringer CE, Smith Jr SC, 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Exper Decision Consensus Pathways. Journal of the American College of Cardiology (2017), doi: 10.1016/j.jacc.2017.07.745. Accessed May 30, 2025.

Nexletol™ (bempedoic acid) [prescribing information]. Ann Arbor, MI: Esperion Therapeutics, Inc.; March 2024. Available from: https://pi.esperion.com/nexletol/nexletol-pi.pdf. Accessed May 30, 2025.

Nexlizet™ (bempedoic acid and ezetimibe) [prescribing information]. Ann Arbor, MI: Esperion Therapeutics, Inc.; March 2024. Available from: https://pi.esperion.com/nexlizet/nexlizet-pi.pdf. Accessed May 30, 2025.

Praluent® (alirocumab) [package insert]. Bridgewater, NJ. Sanofi-Aventis US LLC. March 2024.  Available from: http://products.sanofi.us/praluent/praluent.pdf. Accessed May 30, 2025.

Repatha® (evolocumab) [package insert]. Thousand Oaks, CA. Amgen Inc. September 2021. Available from: https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/repatha/repatha_pi_hcp_english.pdf. Accessed May 30, 2025.

Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce cardiovascular risk in adults: a report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines. Circulation. 2013. https://doi.org/10.1161/01.cir.0000437738.63853.7a. Accessed May 30, 2025.

Varghese MJ. Familial hypercholesterolemia: a review. Ann Pediatr Cardiol. 2014;7:107-17. Accessed May 30, 2025.


186/5/20256/4/20267/1/2025 1:24 AMNo presence informationsrv_ppsgw_P
Rx.01.33 Off-Label Use 
Brand nameGeneric name
Juxtapid®Lomitapide
Praluent®alirocumab
Repatha®evolocumab
Nexletol™Bempedoic acid
Nexlizet™Bempedoic acid/ezetimibe

n/an/a
542
  
4/1/2025Rx.01.171CommercialVanHorn, LynnseyQ4-2024

Bile acid synthesis disorders (BASD) are extremely rare, genetic, metabolic conditions that exhibit manifestations of liver disease, steatorrhea, and complications from decreased fat soluble vitamin absorption.  Individuals with BASD lack the enzymes needed to synthesize cholic acid.  If untreated, these individuals fail to grow and can develop life-threatening liver injury. 

Cholic acid is a primary bile acid synthesized from cholesterol in the liver. In bile acid synthesis disorders due to single enzyme deficiencies (SEDs) in the biosynthetic pathway, and in peroxisomal disorders (PDs) including Zellweger spectrum disorders, deficiency of primary bile acids leads to unregulated accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption by forming mixed micelles, and facilitate absorption of fat-soluble vitamins in the intestine.

Endogenous bile acids, including cholic acid, enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions.

Cholic acid (Cholbam®) is indicated for:

  1. The treatment of BASD due to SEDs
  2. Adjunctive treatment of PDs including Zellweger spectrum disorders, in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.​

Treatment with cholic acid (Cholbam®) is approved for children aged 3 weeks and older, and adults.
The intent of this policy is to communicate the medical necessity criteria for cholic acid (Cholbam®) as provided under the member's prescription drug benefit.

INITIAL CRITERIA Cholic acid (Cholbam®) is medically necessary when ALL of the following are met:

  1. One of the following:
    1. Treatment of bile acid synthesis disorder due to a single enzyme defect (SED); or
    2. Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorder in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat soluble vitamin absorption; and
  2. Prescribed by or in consultation with one of the following:
    1. hepatologist; or
    2. gastroenterologist; or
    3. medical geneticist; or
    4. other specialist that treats inborn errors of metabolism; and
  3. No documentation of extrahepatic manifestations of bile acid synthesis disorders due to single enzyme defects (SEDs) or peroxisomal disorders (PDs) including Zellweger spectrum disorder

Initial authorization duration: 3 months
 
REAUTHORIZATION CRITERIA Cholic acid (Cholbam®) is medically necessary when there is documentation of improved liver function tests (e.g., aspartate aminotransferase [AST], alanine aminotransferase [ALT]) from the start of treatment.

Reauthorization duration: 2 years


N/A

Cholbam® (Cholic acid) [package insert]. Baltimore MD. Asklepion Pharmaceuticals, LLC. May 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205750s000lbl.pdf. Accessed December 15, 2024

Cholic acid. Micromedex 2.0. Truven Health Analytics, Inc. Greenwood Village, CO.  Available from: http://www.micromedexsolutions.com. Accessed December 15, 2024


1112/12/202412/11/20254/1/2025 1:12 AMNo presence informationsrv_ppsgw_P
Rx.01.33 Off-Label Use
Brand NameGeneric Name
Cholbam®cholic acid

N/AN/A
680
  
10/1/2025Rx.01.285CommercialVanHorn, LynnseyQ2-2025
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 medically necessary when all of the following are met:

  1. Diagnosis of cardiovascular disease (CV); and
  2. Used for the secondary prevention of CV disease (e.g., very high-risk patients); and
  3. Member is 18 years of age or older; and
  4. Member is on maximally tolerated therapy with at least two agents for coronary disease [e.g., antiplatelet (aspirin), lipid-lowering agent (statin [atorvastatin], ezetimibe, PCSK9 inhibitors [evolocumab]), beta-blocker (atenolol) or renin-angiotensin-aldosterone system blockers (lisinopril)]; and
  5. One of the following:
    1. Trial of generic colchicine tablet ;or
    2. Member is not a candidate for generic colchicine tablet

Initial authorization duration: 6 months

REAUTHORIZATION CRITERIA: Colchicine (Lodoco) is medically necessary when all of the following are met:

  1. Documentation is provided of positive clinical response to therapy; and
  2. One of the following:
    1. Trial of generic colchicine tablet ;or
    2. Member is not a candidate for generic colchicine tablet

Reauthorization duration: 12 months

None
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 May 30, 2025.

Lodoco (colchicine) [prescribing information]. Parsippany, NJ: AGEPHA Pharma USA, LLC. June 2023. Available from: https://lodoco.com/. Accessed May 30, 2025 
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Rx.01.33 Off-Label Use 
Brand NameGeneric Name
Lodoco

Colchicine

LodocoColchicine
693
  
10/1/2025Rx.01.252CommercialVanHorn, LynnseyQ2-2025
Paroxysmal nocturnal hemoglobinuria (PNH) is a disorder of the hematopoietic stem cell associated with hemolytic anemia (from uncontrolled complement activation), bone marrow failure, and thrombosis. PNH results from a nonmalignant somatic mutation in the X-linked phosphatidylinositol glycan class A (PIGA) gene in a self-renewing hematopoietic stem cell. The mutation leads to deficiencies in GPI-anchored proteins on hematopoietic cells, including CD55 and CD59. The deficiency of CD55 and CD59 results in activation of the alternative complement pathway.

IgAN (also known as Berger’s disease) is an autoimmune kidney disease in which IgA accumulates and attacks the glomeruli. This impairs the kidney’s ability to filter, causing blood and protein to leak into the urine. Patients will usually present with hematuria, flank pain, swelling in the ankles, and high blood pressure. After living with IgAN for ≥10 years, up to 40% of patients will develop ESRD, requiring dialysis or renal transplant. Therefore, the goal in treating IgAN is to prevent or delay progression to ESRD. The exact cause of IgAN is unknown.

C3 glomerulopathy (C3G) is a rare glomerular disease that causes progressive kidney dysfunction due to dysregulation of the complement system’s alternative pathway. This dysregulation leads to excessive C3 protein deposits in the glomeruli, which damage the kidney’s filtering units and impair their ability to remove waste from the blood. C3G presents with variable features including proteinuria, hematuria, nephrotic syndrome, and declining kidney function—symptoms that often overlap with other glomerular diseases, complicating diagnosis.

Pegcetacoplan is a complement inhibitor that binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation.

Empaveli™ is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Iptacopan binds to Factor B of the alternative complement pathway and regulates the cleavage of C3, generation of downstream effectors, and the amplification of the terminal pathway. In PNH, intravascular hemolysis (IVH) is mediated by the downstream membrane attack complex (MAC), while extravascular hemolysis (EVH) is facilitated by C3b opsonization. Iptacopan acts proximally in the alternative pathway of the complement cascade to control both C3b-mediated EVH and terminal complement-mediated IVH. In IgAN, the deposition of galactose deficient IgA1 (Gd-IgA1) containing immune complexes in the kidney locally activates the alternative complement pathway which is thought to contribute to the pathogenesis of IgAN. By binding to Factor B, iptacopan inhibits the effect of the alternative pathway. 

FABHALTA is a complement factor B inhibitor, indicated for:
  • the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 
  • the reduction of 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. (1.2) This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether FABHALTA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
  • the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria. 
VOYDEYA is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) (1). Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.

Danicopan binds reversibly to complement Factor D and selectively inhibits the alternative complement pathway. Danicopan prevents the cleavage of complement Factor B into the Ba and Bb fragments which are required for the formation of the alternative pathway (AP) complement component C3 convertase (C3bBb), the generation of downstream effectors including C3 fragment opsonization, and the amplification of the terminal pathway. In PNH, intravascular hemolysis (IVH) is mediated by the terminal membrane attack complex (MAC), while extravascular hemolysis (EVH) is facilitated by C3 fragment opsonization. Danicopan acts proximally in the alternative pathway of the complement cascade to control preferentially C3 fragment-mediated EVH, while co-administered ravulizumab or eculizumab is anticipated to maintain control over MAC-mediated IVH. 
The intent of this policy is to communicate the medical necessity criteria for pegcetacoplan (Empaveli™), iptacopan (Fabhalta®), and danicopan (Voydeya™) as provided under the member's prescription drug benefit.

Paroxysmal Nocturnal Hemoglobinuria

INITIAL CRITERIA Pegcetacoplan (Empaveli™) is medically necessary when ALL of the following are met:

  1. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); and
  2. Member is 18 years of age or older; and
  3. Prescribed by or in consultation with a hematologist/oncologist; and
  4. Member's Hemoglobin (Hb) level is less than 10.5 g/dL

Initial authorization duration: 12 months

CONTINUATION CRITERIA Pegcetacoplan (Empaveli™) is medically necessary with documentation of positive clinical response to therapy (e.g., improvement in hemoglobin level, hemoglobin stabilization, decrease in the number of red blood cell transfusions)

Continuation authorization duration: 12 months

INITIAL CRITERIA: Iptacopan (Fabhalta®) is medically necessary when ALL of the following are met:

  1. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); and
  2. Member is 18 years of age or older; and
  3. Member's Hemoglobin (Hb) level is less than 10 g/dL; and
  4. Prescribed by or in consultation with a hematologist/oncologist

Initial authorization duration: 12 months

CONTINUATION CRITERIA: Iptacopan (Fabhalta®) is medically necessary with documentation of positive clinical response to therapy (e.g., improvement in hemoglobin level, hemoglobin stabilization, decrease in the number of red blood cell transfusions)

Continuation authorization duration: 12 months

INITIAL CRITERIA: Danicopan (Voydeya™) is medically necessary when ALL of the following are met:

  1. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); and
  2. Member is 18 years of age and older; and
  3. Will be used as add-on therapy to ravulizumab (Ultomiris) or eculizumab (Soliris); and
  4. Member's hemoglobin levels less than or equal to 9.5 g/dL; and
  5. Absolute reticulocyte count greater than or equal to 120 x 109/L; and
  6. Prescribed by or in consultation with a hematologist/oncologist

Initial authorization duration: 12 months

CONTINUATION CRITERIA: Danicopan (Voydeya™) is medically necessary when ALL of the following are met:

  1. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); and
  2. Documentation of positive clinical response to therapy (e.g., hemoglobin stabilization, decrease in the number of red blood cell transfusions); and
  3. Will be used as add-on therapy to ravulizumab (Ultomiris) or eculizumab (Soliris)

Continuation authorization duration: 12 months

Immunoglobulin A nephropathy (IgAN)

INITIAL CRITERIA: Iptacopan (Fabhalta®) is medically necessary when ALL of the following are met:
  1. Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy; and
  2. 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
  3. Medication will be used to reduce proteinuria; and
  4. Member has an estimated glomerular filtration rate (eGFR) of greater than or equal to 20 mL/min/1.73 m2; and
  5. Member had an inadequate response or inability to tolerate a minimum 90-day trial of a maximally tolerated dose of one of the following:
    1. An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril); or
    2. An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan); and
  6. Member is 18 years of age and older; and
  7. Prescribed by or in consultation with a nephrologist
Initial authorization duration: 12 months
 
CONTINUATION CRITERIA: Iptacopan (Fabhalta®) is medically necessary when ALL of the following are met:
  1. Documentation of positive clinical response to therapy as demonstrated by a decrease in urine protein-to-creatinine ratio (UPCR) from baseline; and
  2. Prescribed by or in consultation with a nephrologist
Continuation authorization duration: 12 months

​Complement 3 Glomerulopathy

INITIAL CRITERIA: Iptacopan (Fabhalta®) is medically necessary when ALL of the following are met:

  1. Diagnosis of kidney complement 3 glomerulopathy (C3G); and
  2. Member is 18 years of age or older; and
  3. Drug will be used to reduce proteinuria; and
  4. Member is on a maximally tolerated renin-angiotensin system (RAS) inhibitor (e.g., benazepril, lisinopril, losartan, valsartan); and
  5. Member has not had a kidney transplant; and
  6. Prescribed by or in consultation with a nephrologist

Initial authorization duration: 12 months

CONTINUATION CRITERIA: Iptacopan (Fabhalta®) is medically necessary when ALL of the following are met:

  1. Member demonstrates a positive clinical response to therapy (e.g., reduction in 24-hour UPCR, stable or improved eGFR compared to baseline); and
  2. Member is on a maximally tolerated renin-angiotensin system (RAS) inhibitor (e.g., benazepril, lisinopril, losartan, valsartan); and
  3. Member has not had a kidney transplant

Continuation authorization duration: 12 months

Pegcetacoplan (Empaveli)

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

See full prescribing information for complete boxed warning.

Meningococcal infections may occur in patients treated with EMPAVELI and may become rapidly life-threatening or fatal if not recognized and treated early. Use of EMPAVELI may predispose individuals to serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae type B.

EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Iptacopan (Fabhalta)

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA 

See full prescribing information for complete boxed warning. 

FABHALTA increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. 

Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of FABHALTA, unless the risks of delaying FABHALTA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. 

Patients receiving FABHALTA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. 

FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called FABHALTA REMS.

Danicopan (Voydeya)

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA See full prescribing information for complete boxed warning

VOYDEYA increases the risk of serious and life-threatening infections, caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B (5.1). • Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of VOYDEYA, unless the risks of delaying VOYDEYA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor (5.1). • Patients receiving VOYDEYA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected (5.1). VOYDEYA is available only through a restricted program called VOYDEYA REMS. 

DynaMed [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - . Record No. T115903, Paroxysmal Nocturnal Hemoglobinuria (PNH); [updated 2018 Nov 30, cited 2021 Oct 01]. Available from https://www.dynamed.com/topics/dmp~AN~T115903. Accessed May 28, 2025.

Empaveli™ (pegcetacoplan) [package insert]. Waltham (MA): Apellis Pharmaceuticals, Inc. September 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c23d89e9-b00b-4520-e053-2995a90a95af. Accessed May 28, 2025.

Fabhalta® (iptacopan) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2025. Available at: fabhalta.pdf (novartis.com). Accessed May 28, 2025.

Voydeya™ (danicopan) [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc. March 2024. Available at: VOYDEYA_USPI.pdf (alexion.com). Accessed May 28, 2025. 


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Rx.01.33 Off Label Use​
Brand NameGeneric Name
Empaveli™Pegcetacoplan
Fabhalta®Iptacopan
​Voydeya™​Danicopan

Fabhalta® iptacopan
657
  
10/1/2025Rx.01.134CommercialVanHorn, LynnseyQ2-2025
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:

  1. 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
  2. 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
  3. 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
  4. The compound does not contain any product(s) that were withdrawn or removed from the market due to safety reasons; and
  5. 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:

  1. All of the above criteria are for medically necessary are met for the compounded product; and
  2. 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 May 29, 2025.

ASHP Guidelines on Outsourcing Sterile Compounding Services. January 2014. Available from:  http://www.ajhp.org/content/71/2/145?sso-checked=true. Accessed May 29, 2025.

International Academy of Compounding Pharmacist. Available from: http://www.iacprx.org/. Accessed May 29, 2025

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 May 29, 2025.


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 May 29, 2025.

Report: Limited FDA Survey of Compounded Drug Products. June 2018. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm, Accessed May 29, 2025.

USP Compounding Standards and Resources.  Available from: http://www.usp.org/usp-healthcare-professionals/compounding?gclid=CJfWt97qmsECFedzMgodCzgA_w. Accessed May 29, 2025.

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Rx.01.33 Off Label Use Policy
ProductDescription
Compound claims greater than $75Compound where the submitted claim cost is greater than or equal to $75
VariousCompounding Kit

N/AN/A
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