Commercial

Medical Policy

Notification

Gonadotropin-Releasing Hormone Agonist (Camcevi™, Eligard®, Fensolvi®, Lupron Depot®)

Notification Issued Date:

This version of the policy will become effective 03/08/2021.

This policy has been updated to communicate the coverage position of leuprolide acetate (Fensolvi), represented by HCPCS J1950. Additionally, the medical necessity criteria have been revised to reflect the updated coverage position from the National Comprehensive Cancer Network (NCCN) for endometriosis, head and neck cancers, ovarian cancer, and prostate cancer.

Title:

Gonadotropin-Releasing Hormone Agonist (Camcevi™, Eligard®, Fensolvi®, Lupron Depot®)

Policy #:

08.01.33h

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

COMPANY-DESIGNATED PREFERRED PRODUCTS

Although there are many leuprolide products on the market (e.g., Camcevi, Eligard, Lupron Depot), there is no reliable evidence of the superiority of any one product of leuprolide compared to other products. Although Lupron Depot (leuprolide acetate) and Camcevi (leuprolide mesylate) have been approved by the US FDA for prostate cancer and Company recognized Drug Compendia supports the use of these for certain cancers, leuprolide acetate (Eligard and Lupron Depot 7.5 mg, represented by HCPCS J9217) are considered to be the lower-cost alternative. The Company has designated leuprolide acetate (Eligard and Lupron Depot 7.5 mg, represented by HCPCS J9217) as its preferred products for the following indications:

prostate cancer
salivary gland tumors

These products are less costly and at least as likely to produce equivalent therapeutic results as the non-preferred leuprolide products, which include, but are not limited to Camcevi (represented by HCPCS J1952), Lupron Depot (represented by HCPCS J1950), and any other non-preferred leuprolide products.

NOTE: All other uses described in this policy as Medically Necessary are eligible for coverage and are not subject to the Company-desigated Preferred Product requirement.

NON-PREFERRED PRODUCTS

Use of the non-preferred leuprolide products, which include, but are not limited to Camcevi (represented by HCPCS J1952), Lupron Depot (represented by HCPCS J1950), and any other non-preferred leuprolide product is considered medically necessary and, therefore, covered only for individuals who are currently receiving or have previously received a non-preferred product for the specified leuprolide indication.

If the individual has not previously received leuprolide to treat the specified indication, these non-preferred products are only eligible for coverage when the individual has contraindication(s) or intolerance(s) to the Company designated preferred product, leuprolide acetate (Eligard and Lupron Depot 7.5 mg, represented by HCPCS J9217).

MEDICALLY NECESSARY INDICATIONS

Leuprolide acetate/mesylate for injection is considered medically necessary and, therefore, covered when the following criteria are met:

Breast Cancer

Leuprolide acetate for injection is considered medically necessary and, therefore, covered for:

Invasive or Inflammatory breast cancer treatment in premenopausal females* with hormone receptor--positive in combination with any of the following:
- Adjuvant endocrine therapy
- Endocrine therapy for recurrent unresectable (local or regional) or stage IV (M1) disease

Central Precocious Puberty

Leuprolide acetate for injection is considered medically necessary and, therefore, covered for children with a clinical diagnosis of central precocious puberty confirmed by all of the following criteria:

An increased pubertal luteinizing hormone response to a GnRH stimulation test
A bone age greater than at least 1 year compared to chronological age

Endometriosis

Leuprolide acetate for injection is considered medically necessary and, therefore, covered for a maximum of 6 months for initial treatment and a maximum of 6 months for retreatment (total 12 months) for the following:

Management of endometriosis, including pain relief and reduction of endometriotic lesions.
Initial management of endometriosis and for management of recurrence of symptoms with norethindrone acetate, 5 mg daily.

Head and Neck Cancers

Salivary Gland Tumors
Leuprolide acetate for injection is considered medically necessary and, therefore, covered as a single agent for the treatment of androgen receptor--positive recurrent disease with either of the following:

distant metastases in individuals with a performance status (PS) of 0-3
unresectable locoregional recurrence or second primary with prior radiation therapy

Gender Dysphoria

Leuprolide acetate for injection is considered medically necessary and, therefore, covered for puberty suppression when all of the following criteria are met:

The adolescent has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed), in accordance with criteria established in the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition, [DSM-5].

Gender dysphoria emerged or worsened with the onset of puberty.

The individual has reached at least Tanner stage 2 of development.

Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

Leuprolide acetate for injection is considered medically necessary and, therefore, covered:

Hormone therapy as a single agent for persistent disease or recurrence of ovarian cancer/fallopian tube cancer/primary peritoneal cancer: (endometrioid, serous epithelial), carcinoma (malignant mixed Mullerian tumors), clear cell carcinoma of the ovary, endometrioid carcinoma, mucinous carcinoma of the ovary

as immediate treatment for serially rising CA-125 in individuals that previously received chemotherapy (clinical relapse)

for progression on primary, maintenance, or recurrence therapy (platinum-resistant disease)

for stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease)

for complete remission and relapse <6 months after completing chemotherapy (platinum-resistant disease)

for radiographic and/or clinical relapse in individuals with previous complete remission and relapse ≥6 months after completing prior chemotherapy (platinum-sensitive disease)

Hormone therapy as a single agent for persistent disease or recurrence of Grade 1 endometrioid carcinoma

treatment for rising CA-125 levels or clinical relapse in individuals who have received no prior chemotherapy
as immediate treatment for serially rising CA-125 in individuals that previously received chemotherapy (clinical relapse)
for progression on primary, maintenance, or recurrence therapy (platinum-resistant disease)
stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease)
for complete remission and relapse <6 months after completing chemotherapy (platinum-resistant disease)
for radiographic and/or clinical relapse in individuals with previous complete remission and relapse ≥6 months after completing prior chemotherapy (platinum-sensitive disease)

As a single agent for clinical relapse in individuals with stage II-IV granulosa cell tumors
Hormone therapy for Low-Grade serous carcinoma (serous, borderline epithelial), as a single agent for platinum-sensitive or platinum-resistant recurrence (if an aromatase inhibitor was given previously)

Prostate Cancer

Leuprolide acetate/mesylate for injection is considered medically necessary and, therefore, covered for:

Treatment (including palliative treatment) for individuals with advanced prostate cancer
Adjuvant androgen deprivation therapy (ADT), as a single agent or in combination with a first-generation antiandrogen, with external beam radiation therapy (EBRT) if adverse features (i.e. positive margins, seminal vesicle invasion, extracapsular extension, or detectable Prostate-Specific Antigen [PSA]) noted after radical prostatectomy (RP) for individuals:

in the very-low-risk group^† and > 20 year expected survivial
in the low-risk group^† and ≥ 10 year expected survival
with or without pelvic lymph node dissection (PLND) and no lymph node metastases in the favorable or unfavorable intermediate-risk group^† and >10 year expected survival
with PLND and no lymph node metastases in the high- or very-high-risk group^† or regional risk group (Any T, N1, M0) and >5 year expected survival or symptomatic

Adjuvant androgen deprivation treatment (ADT) as a single agent or in combination with a first-generation antiandrogen, without external beam radiation therapy (EBRT) if lymph node metastasis found during pelvic lymph node dissection (PLND) for individuals:

in the favorable or unfavorable intermediate risk group^† and > 10 year expected survival
in the high or very high risk groups^† and >5 year expected survival or symptomatic
in the regional risk group (Any T, N1, M0) and >5 year expected survival or symptomatic

Androgen deprivation therapy (ADT) as:

a single agent if life expectancy ≤5 years and symptomatic, in individuals with very-low-, low-, and intermediate-risk disease^†
as a single agent if life expectancy ≤5 years and asymptomatic, in individuals with high risk^† or very high risk^† disease where complications such as hydronephrosis or metastasis can be expected within 5 years
a single agent (National Comprehensive Cancer Network [NCCN] preferred with EBRT), in combination with first-generation antiandrogen (NCCN preferred with EBRT), or in combination with abiraterone with concurrent steroids (prednisone or methylprednisolone) in individuals with regional risk disease (Any T, N1, M0) and life expectancy > 5 years or symptomatic
as a single agent for individuals in the regional risk group (Any T, N1, M0) and life expectancy ≤ 5 years and asymptomatic

ADT as a single agent or in combination with a first-generation antiandrogen for:

M0 Prostate-Specific Antigen (PSA) persistence/recurrence after radical prostatectomy in combination with EBRT if studies negative for distant metastatic disease or imaging not performed
M0 PSA recurrence or positive digital rectal examination (DRE) after EBRT if biopsy positive, studies negative for distant metastatic disease and life expectancy ≤ 10 years
M0 PSA recurrence or positive DRE after EBRT if biopsy negative and studies negative for distant metastatic disease

Initial ADT with EBRT as a single agent or in combination with a first-generation antiandrogen if life expectancy >5 years or symptomatic:
- for 4-6 months with or without brachytherapy for individuals in the unfavorable intermediate risk group†
- for 1.5-3 years for individuals in the high or very high risk group†
- for 2 years of ADT in combination with docetaxel or abiraterone for individuals in the very high risk group† only
- for 1-3 years with brachytherapy for individuals in the high or very high risk group†
- as a single agent (NCCN preferred regimen), in combination with a first generation anti-androgen (NCCN preferred regimen), or in combination with abiraterone with concurrent steroid (prednisone or methylprednisolone) for individuals in the regional risk group (any T, N1, M0)
Single-agent treatment for individuals who progressed on observation of localized disease
For castration-naïve disease

As a single agent for M0 or M1 disease (Note per National Comprehensive Cancer Network [NCCN]: A first-generation antiandrogen must be given for ≥7 days to prevent testosterone flare if metastases are present in weight-bearing bone)
In combination with a first-generation antiandrogen for M0 or M1 disease
in combination with docetaxel (NCCN preferred regimen) with or without a first-generation antiandrogen for M1 disease (Note per NCCN: A first-generation antiandrogen must be given for ≥7 days to prevent testosterone flare if metastases are present in weight-bearing bone)
in combination with either apalutamide or enzalutamide for M1 disease (both NCCN preferred regimens)
in combination with abiraterone and prednisone for M1 disease (NCCN preferred regimen)
as a single agent or in combination with a first-generation antiandrogen and EBRT to the primary tumor for low volume M1 disease

For M0 or M1 castration-resistant disease as androgen deprivation therapy (ADT) to maintain castrate levels of serum testosterone (less than 50 ng/dL)

* Men with breast cancer should be treated similarly to postmenopausal women, except that use of an aromatase inhibitor is ineffective without concomitant suppression of testicular steroidogenesis.

^†According to National Comprehensive Cancer Network guidelines:

very low risk refers to individuals with clinical stage T1c, Grade Group 1, PSA less than 10 ng/mL, fewer than three prostate biopsy fragments/cores positive with 50% or less cancer in each fragment/core, and PSA density less than 0.15 mg/mL/g.
low risk refers to individuals with clinical stage T1 to T2a, Grade Group 1, and PSA less than 10 ng/mL.
intermediate risk refers to individuals
- who have no high- or very-high-risk features and has one or more intermediate risk factors (IRF):
  - clinical stage T2b to T2c
  - Grade Group 2 or 3
  - PSA 10 ng/mL to 20 ng/mL
- favorable intermediate risk refers to individuals with 1 IRF, Grade Group 1 or 2, and <50% biopsy cores positive
- unfavorable intermediate risk refers to individuals with 2 or 3 IRFs, and/or Grade Group 3, and/or 50% or more biopsy cores positive
high risk refers to individuals who have no very-high-risk features and has at least one high-risk feature:

clinical stage T3a, Grade Group 4 or 5, or PSA greater than 20 ng/mL

very high-risk refers to individuals with clinical stage T3b to T4 , or primary Gleason pattern 5, or 2-3 high-risk features, or more than 4 biopsy cores with grade Group 4 or 5

Uterine Leiomyomata (Uterine Fibroids)

Leuprolide acetate for injection is considered medically necessary and, therefore, covered for the preoperative hematologic improvement of individuals with anemia caused by uterine leiomyomata concomitantly with iron therapy. According to the FDA-approved label, duration of therapy should be limited to up to 3 months.

NOT MEDICALLY NECESSARY 

The Company's products contain a definition of medical necessity that includes a requirement that a service not be more costly than an alternative service that is at least as likely to produce equivalent therapeutic or diagnostic results for the treatment of an individual's illness.
Although Lupron Depot (leuprolide acetate) has been approved by the FDA for prostate cancer and Compendia supports the use of Lupron Depot for multiple types of cancers, Eligard (leuprolide acetate) considered to be the lower-cost alternative.

For individuals receiving their first course of leuprolide for the following indications, use of Lupron Depot (represented by HCPCS J1950) is considered not medically necessary and, therefore, not covered for the following indications since they are more costly than the preferred product that is at least as likely to produce equivalent therapeutic results for that individual's condition.

prostate cancer
salivary gland tumors

For individuals receiving their first course of leuprolide for the following indications, use of leuprolide acetate (Fensolvi represented by HCPCS J1951) is considered not medically necessary and, therefore, not covered for the following indications since it is more costly than the preferred products and at least as likely to produce equivalent therapeutic results for that individual's condition.

Breast cancer
Endometriosis
Gender Dysphoria
Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
Prostate cancer
Salivary gland tumors
Uterine Leiomyomata (Uterine Fibroids)

For individuals receiving their first course of leuprolide for the following indications, use of leuprolide mesylate (Camcevi represented by HCPCS J1952) is considered not medically necessary and, therefore, not covered for the following indications since it is more costly than the preferred products and at least as likely to produce equivalent therapeutic results for that individual's condition.

Breast cancer
Central Precocious Puberty
Endometriosis
Gender Dysphoria
Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
Prostate cancer
Salivary gland tumors
Uterine Leiomyomata (Uterine Fibroids)

EXPERIMENTAL/INVESTIGATIONAL

All other uses for gonadotropin releasing hormone agonist (Camcevi, Eligard, Fensolvi, Lupron Depot) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

MANDATES

PENNSYLVANIA MEMBERS
In accordance with the Commonwealth of Pennsylvania's >Act 6 of 2020< or >Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive agents (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

GLEASON SCORE

The Gleason Score is a grading system for prostate cancer tissue. This score is determined by characterizing the prostate cancer cells on a grade scale of 1 (most differentiated) to 5 (least differentiated) based on its appearance under a microscope. The two most prevalent grades are added up to equal the Gleason score. Generally prostate cancer with a Gleason score 2-4 is considered well-differentiated or low grade; Gleason score 5-7 is considered moderately differentiated; Gleason score 8-10 is considered poorly differentiated or high-grade.

GRADE GROUP

A revised grading system for prostate cancer tissue was created at the 2014 International Society of Urological Pathology Consensus Conference, which further assigns Grade Groups, derived from the the Gleason Score.

Grade Group	Gleason Score	Gleason Pattern
1	≤ 6	≤ 3 + 3
2	7	3 + 4
3	7	4 + 3
4	8	4 + 4, 3 + 5, 5 + 3
5	9 or 10	4 + 5, 5 + 4, 5 + 5

TANNER SCALE

Tanner Score is a scale of progression through puberty. Males are rated for genital development and pubic hair growth. Females are rated for breast development and pubic hair growth. Males and females are categorized into one of five stages, Stage 1 (preadolescent) to Stage 5 (adult).

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, gonadotropin-releasing hormone agonist (Camcevi, Eligard, Fensolvi, Lupron Depot) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, drugs that are identified in this policy with uses that are considered not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Leuprolide acetate (Eligard) for injection, 7.5 mg for 1-month administration, 22.5 mg for a 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration was approved by the FDA on January 2002 for palliative treatment of advanced prostate cancer. The safety and effectiveness of leuprolide acetate (Eligard) for injection in pediatric individuals have not been established.

Leuprolide acetate (Fensolvi) for injection, 45 mg for 6-month administration was approved by the FDA on May 1, 2020 for treatment of children with central precocious puberty. The safety and effectiveness in pediatric individuals below the age of 2 years have not been established; therefore, its use in children under 2 years is not recommended.

Leuprolide acetate (Lupron Depot) for injection, 7.5 mg for 1-month administration, 22.5 mg for a 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration was approved by the FDA on January 1989 for palliative treatment of advanced prostate cancer. In 2022, the prescribing information for was revised from "palliative treatment" to "treatment" of advanced prostatic cancer.

Leuprolide acetate (Lupron Depot), for injection, 3.75 mg for 1-month administration and 11.25 mg for 3-month administration was approved by the FDA on October 1990 for

Management of endometriosis, including pain relief and reduction of endometriotic lesions
Preoperative hematologic improvement of individuals with anemia caused by uterine leiomyomata

Leuprolide acetate (Lupron Depot-PED) for injection was approved by the FDA on April 1993 for treatment of children with central precocious puberty. The safety and effectiveness in pediatric individuals below the age of 1 year have not been established; therefore, its use in children under 1 year is not recommended.

Leuprolide mesylate injectable emulsion, for subcutaneous use (Camcevi), 42 mg for a 6-month administration, was approved by the FDA on May 25, 2021 for treatment of adults with advanced prostate cancer. The safety and effectiveness in pediatric individuals have not been established.

Description

Gonadotropin-releasing hormone (GnRH) analog is a 10-amino acid peptide that stimulates the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). GnRH directly increases its own receptor number by pulsatile secretion. GnRH analogs have a greater potency than the natural hormone and have a longer half-life. Initially GnRH analogs stimulate the secretion of FSH and LH. With a continued secretion of GnRH analogs there is a decrease in the GnRH receptors leading to a decrease in FSH and LH secretion.

CAMCEVI

On May 25, 2021, leuprolide injectable emulsion, for subcutaneous use (Camcevi) was approved by the FDA for the treatment of adults with advanced prostate cancer and is administered subcutaneously 42 mg every 6 months.

ELIGARD

In January 2002, Leuprolide acetate (Eligard) was FDA-approved for palliative treatment of advanced prostate cancer. Leuprolide acetate (Eligard) is administered subcutaneously 7.5 mg every month, 22.5 mg every three months, 30 mg every four months, or 45 mg every 6 months.

FENSOLVI

On May 1, 2020, leuprolide acetate (Fensolvi) for injection was approved by the FDA for treatment of children with central precocious puberty. Leuprolide acetate (Fensolvi) is administered subcutaneously 45 mg every 6 months.

LUPRON DEPOT

Leuprolide acetate (Lupron Depot) is a synthetic nonapeptide analog of the naturally occurring GnRH. The continuous administration results in suppression of ovarian and testicular steroidogenesis. Leuprolide acetate (Lupron Depot), 7.5 mg for 1-month administration, was approved by the US Food and Drug Administration (FDA) in January 1989 for palliative treatment of advanced palliative prostatic cancer. Three additional doses of leuprolide acetate (Lupron Depot) were approved: 22.5 mg for a 3-month administration (in January 1996), 30 mg for 4-month administration (in July 1997), and 45 mg for 6-month administration (in June 2011). In 2022, the prescribing information for leuprolide acetate (Lupron Depot) was revised from the palliative treatment of advanced prostatic cancer to the treatment of advanced prostatic cancer. Leuprolide acetate (Lupron Depot), 3.75 mg for 1-month administration, was approved by the FDA for management of endometriosis, including pain relief and reduction of endometriotic lesions. Leuprolide acetate (Lupron Depot) given monthly with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. According to the FDA- approved label, initial treatment or retreatment should be limited to 6 months. Leuprolide acetate (Lupron Depot) was also FDA-approved for pre-operative hematologic improvement of individuals with anemia caused by uterine leiomyomata (uterine leiomyoma or uterine fibroid) when used with iron therapy. According to the FDA-approved label, the recommended duration of therapy is up to 3 months. A dosage of 11.25 mg every 3 months can also be administered for endometriosis and uterine leiomyomata.

In 1993, Leuprolide acetate (Lupron Depot-PED) was FDA approved for the treatment of children with central precocious puberty. The dosage is 7.5 mg, 11.25 mg, or 15 mg for 1-month administration, based on the child’s weight, or 11.25 mg or 30 mg for 3-month administration. Central precocious puberty is defined as early onset of secondary sexual characteristics (generally before the age of 8 for girls and before the age of 9 for boys) associated with pubertal pituitary gonadotropin activation. This can result in significantly advanced bone age and diminished adult height. Leuprolide acetate (Lupron Depot-PED) treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the professional provider.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

American Hospital Formulary Services (AHFS) Drug Information 2022. Leuprolide Acetate. [Lexi-Comp website]. 01/11/2021. Available at: http://online.lexi.com/lco/action/home# [via subscription only]. Accessed July 22, 2022.

American Association of Gynecologic Laparoscopists (AAGL): Advancing minimally invasive gynecology worldwide. AAGL Practice Report: Practice guidelines for the diagnosis and management of submucous leiomyomas. J Minim Invasive Gynecol. 2012;19(2):152-71.

Burstein H, Lacchetti C, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline update on ovarian suppression. J Clin Oncol. 2016;34(14):1689-1701.

Camcevi (leuprolide) injectable emulsion, for subcutaneous use. Accord BioPharma Inc .; Durham, NC. 05/2021. Available at: https://www.camcevi.com/ . Accessed July 20, 2022.

Clowse M, Behera M, Anders C, et. al. Ovarian preservation of GnRH agonists during chemotherapy: a meta-analysis. J Womens Health. 2009;18(3):311-19.

Company Benefit Contracts.

ECRI Institute. Hormonal treatment with GnRH analogues to suppress puberty in transgender children and adolescents. Plymouth Meeting (PA): ECRI Institute; 2016 Jun 20. (Custom Rapid Responses).

Eligard (Leuprolide acetate for injectable suspension). Tolmar Pharmaceuticals, Inc. 04/2019. Available at: http://eligard.com/. Accessed July 20, 2022.

Elsevier's Clinical Pharmacology Compendium. Leuprolide. [ClinicalKey Web site]. 06/16/2022. Available at: https://www.clinicalkey.com/pharmacology/. [via subscription only]. Accessed July 22, 2022.

Fensolvi. (Leuprolide acetate for injectable suspension). Tolmar Pharmaceuticals, Inc; Fort Collins, CO. 04/2022. Available at: https://fensolvi.com/. Accessed July 20, 2022.

Guss C, Shumer D, Katz-Wise S. Transgender and gender nonconforming adolescent care: Psychosocial and medical considerations. Curr Opin Pediatr. 2015;26(4):421-426.

Hembree W, Cohen-Kettenis P, Delemarre-van de Waal H, et al. Endocrine treatment of transsexual persons: An Endocrine Society clinical practice guidelines. J Clin Endocrinol Metab.2009;94(9):3132-3154.

Lexi-Drugs Compendium. Leuprolide. [Lexicomp Online Web site]. 07/22/2022. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 22, 2022.

Lexi-Drugs Compendium: Pediatric and Neonatal. Leuprolide. [Lexicomp Online Web site]. 07/22/2022. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 22, 2022.

Lupron Depot® (Leuprolide acetate for depot suspension). AbbVie Inc. Prostate Cancer Indications: Updated 04/2022. Endometriosis and Fibroid Indications: 11.25 mg updated 03/2020; 3.75 mg updated 02/2021. Available at: http://www.lupron.com/. Accessed July 21, 2022.

Lupron Depot-PED® (Leuprolide acetate for depot suspension). AbbVie Inc. 04/2022. Available at: http://www.lupron.com/. Accessed July 21, 2022.

Micromedex® Healthcare Series. Leuprolide Acetate. [Micromedex Web site]. Last modified 06/24/2022. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed July 22, 2022.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Leuprolide acetate, Leuprolide acetate for depot suspension, Leuprolide mesylate. [NCCN Web site]. 2022. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed July 21, 2022.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Breast Cancer V4.2022. [NCCN Web site]. 06/21/2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf [via subscription only]. Accessed July 21, 2022.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Head and Neck Cancers V2.2022. [NCCN Web site]. 04/26/2022. Available at: [via subscription only]. Accessed July 21, 2022.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Ovarian Cancer V2.2022. [NCCN Web site]. 07/13/2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf [via subscription only]. Accessed July 21, 2022.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Prostate Cancer V4.2022. [NCCN Web site]. 05/10/2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf [via subscription only]. Accessed July 21, 2022.

Rugo H, Rumble B, Macrae E, et. al. Endocrine therapy for hormone receptor-positive metastatic breast cancer: American Society of Clinical Oncology guideline. J Clin Oncol. 2016;34(25):3069-103.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate for depot suspension (LUPRON DEPOT 3.75 mg) prescribing information. [FDA Web site]. 02/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 21, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate for depot suspension (LUPRON DEPOT 7.5, 22.5, 30, 45 mg) prescribing information. [FDA Web site]. 04/2022. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 21, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate for depot suspension (LUPRON DEPOT 11.25 mg) prescribing information. [FDA Web site]. 03/2020. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 21, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate for depot suspension (LUPRON DEPOT-PED) prescribing information. [FDA Web site]. 04/2022. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 21, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate for injectable suspension, subcutaneous (Fensolvi) prescribing information. [FDA Web site]. 04/22/2022. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 20, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate (ELIGARD) prescribing information. [FDA Web site]. Revised 02/2019. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 20, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide injectable emulsion, for subcutaneous use (Camcevi) prescribing information. [FDA Web site]. 05/25/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 15, 2022.

World Professional Association for Transgender Health (WPATH). Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. 09/15/2022. Available at: https://www.wpath.org/publications/soc . Accessed November 22, 2022.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

See Attachment A, B, C, and D.

HCPCS Level II Code Number(s)

THE FOLLOWING HCPCS CODE IS USED TO REPRESENT LUPRON DEPOT

J1950 Injection, leuprolide acetate (for depot suspension), per 3.75mg

THE FOLLOWING HCPCS CODE IS USED TO REPRESENT FENSOLVI

J1951 Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 mg

THE FOLLOWING HCPCS CODE IS USED TO REPRESENT CAMCEVI

J1952 Leuprolide injectable, camcevi, 1 mg

THE FOLLOWING HCPCS CODE IS USED TO REPRESENT ELIGARD AND LUPRON DEPOT

J9217 Leuprolide acetate (for depot suspension), 7.5 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

1/2/2023

Version Issued Date:

12/30/2022

Version Reissued Date: