Leuprolide (leuprolide acetate depot) prior authorization and medical necessity criteria - OpenPayer

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Leuprolide (leuprolide acetate depot) prior authorization and medical necessity criteria - OpenPayer

Coverage Summary

This policy applies to multiple leuprolide acetate depot formulations (brand and generic depot products such as Lupron Depot®, Lupron Depot‑Ped®, Eligard®, Fensolvi®, Camcevi®, Lutrate Depot®, Vabrinty™, Leuprolide Acetate Depot, and others) and defines utilization management via prior authorization. Covered indications include central precocious puberty (CPP), endometriosis, uterine leiomyomata (fibroids), multiple oncology indications (breast, prostate, ovarian/fallopian tube/primary peritoneal, head & neck, uterine sarcoma), gender dysphoria, prevention/management of menstrual bleeding associated with hematopoietic stem cell transplant (HCT), and fertility preservation while receiving chemotherapy. The policy requires prior authorization for the referenced HCPCS/J‑codes and provides indication‑specific clinical criteria, dosing/administration guidance, and billing/unit limits (per HCPCS and indication). Initial authorization lengths and renewal rules vary by indication and are specified in the policy (examples: typically 12 months initial; endometriosis 6 months; HCT bleeding prevention 6 months; uterine fibroids 3 months).

Medical Necessity Criteria (Initial and Renewal)

General initial requirement

Prior authorization is provided when ALL of the following are met:

Patient is at least 18 years of age (unless otherwise specified)

Age exceptions specified in indication-specific criteria

Central Precocious Puberty (CPP) - Initial

Coverage provided when ALL of the following are met:

Patient must have a contraindication, intolerance, or failure to Leupron Depot-Ped®, Supprelin® LA, AND Triptodur® prior to consideration of Fensolvi®
Patient is less than 13 years of age
Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation
Hormonal confirmation: Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native growth hormone-releasing hormone (GnRH)
Bone age advanced greater than 2 standard deviations (SD) beyond chronological age

Endometriosis - Initial

Coverage provided when ALL of the following are met:

Endometriosis - Initial: Patient's diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment)

Diagnostic confirmation/workup required (not presumptive)

Breast Cancer - Initial

Coverage provided when ALL of the following are met:

Either

Female premenopausal
- Patient is a premenopausal woman
- Disease is hormone receptor-positive
- And used in combination with
  - Used in combination with adjuvant endocrine therapy
  - Used in combination with endocrine therapy for recurrent unresectable (local or regional) or stage IV (M1) disease
Male

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer - Initial

Coverage provided when ALL of the following are met:

Either

Granulosa cell tumors
- Used as a single agent
- Patient has a diagnosis of stage II-IV granulosa cell tumors
- AND
  - Patient has relapsed disease
Other epithelial/related histologies
- Used as a single agent

Prostate Cancer - Initial

Coverage provided when ALL of the following are met:

Prostate Cancer - Initial: Patient must have a contraindication, intolerance, or failure to Camcevi®, Eligard®, AND Firmagon® prior to consideration of Lupron®

Prior alternatives required before Lupron consideration

Uterine Neoplasms - Uterine Sarcoma - Initial

Coverage provided when ALL of the following are met:

Patient has a diagnosis of low-grade endometrial stromal sarcoma (ESS) or adenosarcoma without sarcomatous overgrowth
Patient is premenopausal and not suitable for surgery (i.e., bilateral salpingo-oophorectomy)
Used for patients with small tumor volume or an indolent growth pace
Used in combination with anastrozole, letrozole, or exemestane

Head and Neck Cancer - Initial

Coverage provided when ALL of the following are met:

Patient has salivary gland tumors
Used as a single agent OR in combination with abiraterone and prednisone
Patient has androgen-receptor positive recurrent disease with distant metastases OR unresectable locoregional recurrence with prior radiation therapy OR unresectable second primary with prior radiation therapy

Prevention/Management of Menstrual Bleeding Associated with HCT - Initial

Coverage provided when ALL of the following are met:

Patient is premenopausal
Patient will receive conditioning myeloablative treatment with cytotoxic chemotherapy OR patient has menorrhagia due to thrombocytopenia related to delayed platelet engraftment

Fertility Preservation While Receiving Chemotherapy - Initial

Coverage provided when ALL of the following are met:

Patient is premenopausal
Patient is receiving treatment with cytotoxic chemotherapy with the potential to cause ovarian damage/toxicity
Examples: cyclophosphamide, melphalan, procarbazine, vinblastine, imatinib
Patient has failed or is not a candidate for other fertility preservation methods (e.g., cryopreservation)

Gender Dysphoria - Initial

Coverage provided when ALL of the following are met:

Pubertal stage: Patient has experienced puberty development to at least Tanner stage 2 (applies only to patients <18 years of age)Tanner stage >=2
Diagnosis confirmation: Patient has a diagnosis of gender dysphoria as confirmed by a qualified mental health professional (MHP) OR DSM-5-TR criteria
MHP confirmations: A qualified MHP has confirmed long-lasting/intense pattern of gender nonconformity or gender dysphoria; worsening with onset of puberty; coexisting problems addressed so patient stable enough for treatment; patient has sufficient mental capacity to give informed consent
Qualified MHP must document these elements

Renewal criteria - CPP

Coverage renewal requires ALL:

Patient is less than 13 years of age
Disease response metrics: Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in height velocity, decrease in BA:CA, and improvement in final height prediction
Toxicity: Absence of unacceptable toxicity from the drug (examples: convulsions, psychiatric symptoms, pseudotumor cerebri)
Growth hormone: Will not be used in combination with growth hormone

Coding (HCPCS, NDC, ICD-10)

Many product-specific NDCs are provided elsewhere in this policy. Providers must select the appropriate ICD-10 diagnosis code when mapping J-codes per payer/MAC guidance and Medicare Part B coverage.

Provider Actions & Billing Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for leuprolide depot products. Initial authorization is typically valid for 12 months unless the indication specifies a different initial duration (Endometriosis: 6 months initial; Prevention/management of menstrual bleeding associated with HCT: 6 months initial; Uterine fibroids: 3 months initial).

J1950
J1951
J1952
J1954
J9217

Prior Authorization

Renewal limits and rules

Renewals are generally every 12 months unless an indication specifies otherwise. Endometriosis: may be renewed one time only for 6 months. Prevention/management of menstrual bleeding associated with HCT: may NOT be renewed. Uterine fibroids: may NOT be renewed. Fertility preservation while receiving chemotherapy: may be renewed every 12 months while the patient is receiving concomitant cytotoxic chemotherapy.

Background & Definitions

Covered products include multiple branded and generic leuprolide acetate depot formulations administered intramuscularly or subcutaneously (e.g., Lupron Depot, Lupron Depot‑Ped, Eligard, Fensolvi, Camcevi, Lutrate Depot, Vabrinty, etc.). The policy references product package inserts, the NCCN Drugs & Biologics Compendium and NCCN Guidelines, clinical practice guidelines (Endocrine Society, WPATH, ACOG), and peer‑reviewed literature as supporting sources for indications, dosing, and monitoring. Because leuprolide depot products have multiple indications, varying dosing schedules, and safety considerations, the policy implements utilization management through prior authorization with indication‑specific medical necessity criteria, dosing/administration instructions, maximal billable units per HCPCS by indication, documentation requirements (diagnostic confirmation, bone density assessment where required), and renewal criteria to ensure appropriate, evidence‑based use and billing.

Qualified mental health professional (MHP): a licensed clinician with at minimum a master's degree (or equivalent training) in a relevant clinical field, able to assess coexisting mental health concerns, capacity to consent, experienced in gender dysphoria assessment, and engaged in continuing education. Additional definitional elements in the policy reference the DSM‑5‑TR criteria and professional guideline standards for confirming gender dysphoria and capacity to consent.

Medicare Determinations

Name	Number	Type	Effective Date
Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs	A52453 / A59160 referenced	LCD (Local Coverage Determination/Article)	2023-01-01 / 2024-03-15
Medicare Part B Covered Diagnosis Codes	A52453	NCD (National Coverage Determination)	(effective date not listed in policy)
Medicare Part B Covered Diagnosis Codes	A59160	NCD (National Coverage Determination)	(effective date not listed in policy)
Note: Follow applicable MAC/Jurisdictional LCD/LCA guidance when billing Medicare Part B for J-codes listed in this policy; use the contractor/local coverage documentation referenced above for claims submission and ICD-10 mapping.

Revision History

2011-11-28origin

Date of origin: 2011-11-28

2025-09-04last_reviewLatest

Last review date: 2025-09-04