POLICY NUMBER

S.5.01.446

Camcevi (leuprolide mesylate)

Eligard (leuprolide acetate)

Fensolvi (leuprolide acetate)

Lupron (leuprolide acetate)

Lutrate (leuprolide acetate)

Vabrinty (leuprolide acetate)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Leuprolide, a gonadotropin-releasing hormone agonist, is a synthetic analog of naturally occurring gonadotropin-releasing hormone (GnRH) possessing greater potency than the natural hormone. Initially, leuprolide increases circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in gonadal steroids (testosterone and dihydrotestosterone in males; estrone and estradiol in premenopausal females). However, continuous daily administration results in decreased LH and FSH in all individuals. In males, testosterone levels decrease to castrate levels, and in premenopausal females, estrogens are reduced to postmenopausal levels. These decreases occur within 2 to 4 weeks after initiation of therapy.

FDA-Approved Indications:

• Camcevi is indicated for the treatment of adult patients with advanced prostate cancer;

• Eligard is indicated for the treatment of advanced prostate cancer;

• Fensolvi is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP);

• Leuprolide acetate 1mg/0.2mL for subcutaneous injection is indicated in the palliative treatment of advanced prostate cancer;

• Leuprolide Acetate Depot is indicated for treatment of advanced prostate cancer;

• Lupron (leuprolide acetate) is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions, with iron therapy before fibroid surgery to improve anemia from fibroids, for the treatment of advanced prostate cancer, and for the treatment of children with central precocious puberty (CPP).

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Eligard (leuprolide acetate) and leuprolide acetate depot are considered medically necessary for the treatment of advanced prostate cancer.

The following medications are not covered on the State Health Plan Medical Drug Formulary:

• Camcevi (leuprolide)

• Lutrate Depot (leuprolide acetate kit)

• Vabrinty (leuprolide acetate)

• Fensolvi (leuprolide acetate)

Initial Criteria

Lupron (leuprolide) may be considered medically necessary when documentation of ONE of the following criteria are provided:

1. The individual has a diagnosis of endometriosis and BOTH of the following:

   1. The individual is 18 years of age or older; AND

   2. The individual is not pregnant and will use non-hormonal contraception while on Lupron (leuprolide);

2. The individual has a diagnosis of uterine leiomyomata and BOTH of the following:

   1. The individual is 18 years of age or older; AND

   2. The individual is not pregnant and will use non-hormonal contraception while on Lupron (leuprolide);

3. The individual has a diagnosis of central precocious puberty (CPP) and ALL of the following:

   1. Onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males associated with pubertal pituitary gonadotropin activation;

   2. Diagnosis confirmed by pubertal response to GnRH stimulation test;

   3. Bone age advanced 1 year beyond the chronological age; AND

   4. Baseline evaluation to include ALL of the following:

      1. Height and weight measurements;

      2. Sex steroid levels;

      3. Adrenal steroid level to exclude congenital adrenal hyperplasia;

      4. Beta human chorionic gonadotropin level to rule out chorionic gonadotropin secreting tumor;

      5. Pelvic/adrenal/testicular ultrasound to rule out steroid secreting tumor; AND

      6. Computerized tomography of the head to rule out intracranial tumor; OR

4. The individual has a diagnosis of prostate cancer.

 Length of Approval:

• Endometriosis: 6 months

• Uterine leiomyomata: 3 months

• Precocious puberty: 6 months

• Prostate cancer: 6 months

Lupron (leuprolide) is considered not medically necessary for ovarian stimulation.

 Renewal Criteria

Lupron (leuprolide) for longer than 3 months for uterine leiomyomata and for longer than 6 months for endometriosis is not recommended and will not be approved for continuation.

Lupron (leuprolide) may be approved for continuation of therapy when ALL of the follow criteria are met:

1. The individual has been previously been approved for therapy through BCBSMS review process; AND

2. One of the following:

   1. The individual has a diagnosis of advanced prostate cancer;

   2. The individual has a diagnosis of precocious puberty and is 12 years of age or younger.

 Length of Approval: 12 months

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Participant's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Participant's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant's medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated. Renewal criteria updated with minor changes for clarity purposes; coverage criteria unchanged. Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description and policy section revised with minor changes for clarity purposes; coverage criteria unchanged. Sources updated.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes C50.A0, C50.A1, and C50.A2.

08/01/2026: Policy title changed from "State and School Employees' Health Insurance Plan - Lupron (leuprolide acetate)" to "State and School Employees' Health Insurance Plan - Leuprolide." Policy description updated to add indications for Camcevi, Eligard, Fensolvi, Leuprolide acetate 1mg/0.2mL for subcutaneous injection, Leuprolide Acetate Depot, and Lupron (leuprolide acetate). Policy section updated to add medically necessary statement for Eligard (leuprolide acetate) and leuprolide acetate depot. Added the following as not covered on the State Health Plan Medical Drug Formulary: Camcevi (leuprolide), Lutrate Depot (leuprolide acetate kit), Vabrinty (leuprolide acetate), and Fensolvi (leuprolide acetate). Sources updated. Code Reference section updated to remove ICD-9 diagnosis codes and add HCPCS codes J1952 and J1954 to the Not Medically Necessary Codes table.

SOURCE(S)

1. Camcevi prescribing information. Accord BioPharma, Inc. February 2026. Last accessed February 2026.

2. Eligard prescribing information. Tolmar Inc. February 2025. Last accessed February 2026.

3. Fensolvi prescribing information. Tolmar Inc. October 2024. Last accessed June 2025.

4. Leuprolide depot prescribing information. Cipla USA Inc. August 2024. Last accessed February 2026.

5. Lupron Depot prescribing information. AbbVie Inc. September 2025. Last accessed February 2026.

6. Lupron Depot-Ped prescribing information. AbbVie Inc. November 2025. Last accessed February 2026.

7. Lutrate Depot prescribing information. Avyxa Pharma, LLC. June 2025. Last accessed February 2026.

8. Vabrinty prescribing information. Uronova Pharmaceuticals, Inc. June 2025. Last accessed February 2026.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Not Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.