Lupron (leuprolide acetate)

POLICY NUMBER

L.5.01.446

Fensolvi (leuprolide acetate)

Lupron (leuprolide acetate)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Lupron (leuprolide acetate), a gonadotropin-releasing hormone agonist, is a synthetic analog of naturally occurring gonadotropin-releasing hormone (GnRH) possessing greater potency than the natural hormone. Initially, Lupron (leuprolide acetate) 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.

Lupron (leuprolide acetate) is FDA-approved for:

• Endometriosis

• Central precocious puberty

• Palliative treatment of advanced prostate cancer

• Uterine leiomyomata (fibroids).

POLICY

Prior authorization is required.

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

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 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 following criteria are met:

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

2. ONE of the following:

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

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

Length of Approval: 12 months

Fensolvi (leuprolide acetate) is considered not medically necessary as other options are covered by the Plan for the treatment of pediatric individuals with central precocious puberty.

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

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 Member'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 Member'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 Member, his or her Provider; and

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

5/1999: Approval by Pharmacy & Therapeutics Committee (P&T).

11/1999: Revisions approved by P&T.

1/17/2001: Added new HCPCS J9219 effective 1-01-2001.

4/9/2001: Breast and Endometrial cancer added as covered indications, ICD-9 diagnosis code 174.0-174.9, 175.0-175.9, 182.0 added covered codes.

1/30/2002: Prior authorization deleted.

2/14/2002: Investigational definition added.

5/1/2002: Type of Service and Place of Service deleted.

11/13/2002: ICD-9 diagnosis codes moved to Code Reference section.

9/10/2004: Code Reference section updated, ICD-9 diagnosis code range 174.0-174.9, 218.0-218.9, 617.0-617.9 listed separately, ICD-9 diagnosis code 173.5, 198.2, 198.81, 198.82, 232.5, 233.0, 233.2 added covered codes, ICD-9 diagnosis code 259.0 deleted covered codes, HCPCS S9560 added covered codes, non-covered codes table deleted, ICD-9 diagnosis code 256.4, 183.0, 198.6, 233.3 deleted non-covered codes, Catamenial pneumothorax, hypersexuality, ovarian stimulation deleted non-covered table.

9/16/2005: Code Reference section updated, CPT code 90782 deleted, ICD-9 diagnosis code 233.4 added.

10/29/2006: Dosing and off-label information removed.

11/2/2006: Code Reference updated. ICD-9 diagnosis codes 173.5, 174-174.6, 174.8, 174.9, 175.0-175.9, 182.0, 198.2, 198.81, 232.5, 233.0 deleted from policy.

7/12/2007: Code Reference updated. ICD-9 diagnosis codes 173.5, 174-174.6, 174.8, 174.9, 175.0-175.9, 182.0, 198.2, 198.81, 232.5, 233.0 added to policy. Breast and endometrial cancer added to policy statement as medically necessary. Ovarian stimulation (256.1) added to policy statement as not medically necessary.

8/25/2008: Added ICD-9 diagnosis code range 256.0 - 256.9 as not medically necessary for ovarian stimulation.

04/01/2014: Policy title changed from "Leuprolide (Lupron®)" to "Leuprolide acetate (Lupron®)." Policy description updated to add "acetate" to Leuprolide (Lupron®). Policy statement intent unchanged.

09/01/2015: Code Reference section updated for ICD-10. Extended ICD-9 diagnosis code 173.5 to the fifth digit as 173.50, 173.51, 173.52, and 173.59.

05/27/2016: Policy number L.5.01.446 added. Policy Guidelines updated to add medically necessary and investigative definitions.

06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

03/27/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

08/03/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Leuprolide acetate (Lupron®)" to "Lupron (leuprolide acetate)." Added drug name to the top of the policy. Added statement to perform a formulary drug search on your patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description updated regarding FDA-approved indications. Added the following statements: 1) Prior authorization is required. 2) The use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Revised medically necessary criteria and added renewal criteria. Sources updated.

10/19/2020: Policy statement criteria for Lupron updated to change "precious" to "precocious." Added policy statement to state that Fensolvi (leuprolide acetate) is considered not medically necessary as other options are covered by the Plan for the treatment of pediatric patients with central precocious puberty. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated. Code Reference section updated to change "Covered Codes" to "Medically Necessary Codes."

07/01/2021: Code Reference section updated to add new HCPCS code J1951, effective 07/01/2021.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated. Policy language updated to change "patients" to "individuals." Policy section revised 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.

SOURCE(S)

1. Fensolvi prescribing information. Tolmar Inc.

   October

   2024. Last accessed

   June 2025.

2. Kota AS, Ejaz S. Precocious Puberty. [Updated 2023 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK544313/

3. Leuprolide. In: Clinical Pharmacology [database on the Internet]. Tampa (FL): Elsevier; 2025 [cited 2025 July 1]. Available from: www.clinicalpharmacology.com . Subscription required to view.

4. Lupron Depot prescribing information. AbbVie Inc. March 2024. Last accessed June 2025.

5. Lupron Depot-Ped prescribing information. AbbVie Inc. May 2025. Last accessed June 2025.

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

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