Currentculinary health fundPolicy N/A

Oncology (Injectable) - Gonadotropin-Releasing Hormone Analogs Management Medical Policy Utilization

Defines prior authorization and approval criteria, dosing limits, prescriber requirements, and covered indications for Camcevi, Camcevi ETM, Eligard, Lutrate Depot, Trelstar, Vabrinty, and Firmagon under the medical benefit.

Policy Summary

Payerculinary health fund

PolicyOncology (Injectable) - Gonadotropin-Releasing Hormone Analogs Management Medical Policy Utilization

Policy CodePolicy N/A

Change TypeAnnual/Selected revisions (agent additions, dosing updates, breast cancer use added)

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests with documentation showing the indication, oncologist/urologist involvement, and dosing that matches one of the policy-listed options; approvals generally issued for 1 year.

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = Breast Cancer: Added new condition of approval and dosing for Eligard and Trelstar under 'Other Uses with Supportive Evidence'.

Selected Revision = Two agents, Camcevi ETM and Vabrinty, were added to the policy.

Selected Revision = Prostate Cancer: Changed 'Leuprolide Depot' to 'Lutrate Depot' in approval criteria and dosing.

Selected Revision = Head and Neck Cancer - Salivary Gland Tumors: Added Trelstar to approval criteria and dosing.

Annual Revision, Summary of Changes = No criteria changes.

7Agents covered

3Covered indications

1 yearApproval duration

Coverage Summary

This policy defines prior authorization and approval criteria, dosing limits, prescriber requirements, and covered indications for the listed GnRH analog agents under the medical benefit: Camcevi, Camcevi ETM, Eligard, Lutrate Depot, Trelstar, Vabrinty, and Firmagon. Prior authorization is recommended and approvals are provided when patients meet the policy's specified criteria and dosing.

The policy governs: (1) authorization criteria for FDA-approved and supportive-evidence indications (primarily advanced prostate cancer, with select breast cancer and androgen receptor-positive salivary gland tumor uses), (2) specified dosing options and frequency limits for each agent, (3) specialist prescriber requirements (prescribed by or in consultation with an oncologist or urologist as specified), and (4) approval durations and renewal expectations (generally 1 year with extended approvals allowed if criteria continue to be met).

Recommended Authorization Criteria - FDA-Approved Indication

Coverage is recommended if the patient meets the indication and dosing and the drug is prescribed by or in consultation with an oncologist or urologist.

ALL of the following

Indication is Prostate Cancer
Prescribed by or in consultation with an oncologist or urologist
Dosing matches one of the FDA-approved dosing options listed for the requested agent

Dosing Options for FDA-Approved Indication (Prostate Cancer)

Approve ONE of the following doses for the specified agent (approval duration = 1 year).

ONE of the following agent-dose blocks

Camcevi: 42 mg subcutaneous injection not more frequently than once every 6 months
Camcevi ETM: 21 mg subcutaneous injection not more frequently than once every 3 months
Eligard: ONE of - i. 7.5 mg SC not more frequently than once every month; ii. 22.5 mg SC not more frequently than once every 3 months; iii. 30 mg SC not more frequently than once every 4 months; iv. 45 mg SC not more frequently than once every 6 months
Firmagon: ONE of - i. Starting dose 240 mg administered as two SC injections of 120 mg; ii. Maintenance dose up to 80 mg as one SC injection not more frequently than once every 28 days (first maintenance dose given 28 days after starting dose)

Other Uses with Supportive Evidence

Recommended Authorization Criteria - Other Uses with Supportive Evidence

Coverage is recommended for listed other uses with specified agent dosing and prescriber specialty; approval duration = 1 year.

Breast Cancer

Indication is Breast Cancer
Prescribed by or in consultation with an oncologist
Agent is Eligard or Trelstar
Dosing matches one of the Eligard or Trelstar options listed under Breast Cancer

Head and Neck Cancer - Salivary Gland Tumors

Patient has recurrent, unresectable, or metastatic disease
Patient has androgen receptor-positive disease
Medication is prescribed by or in consultation with an oncologist
Approve ONE of the listed dosing options for Camcevi, Camcevi ETM, Eligard, Vabrinty, or Trelstar (doses matched to agent as listed in policy)

Applicable Codes and Agent List

Drugs covered by policy (agent list)mixedCovered

Camcevi	leuprolide subcutaneous injection - Accord BioPharma
Camcevi ETM	leuprolide subcutaneous injection - Foresee Pharmaceuticals
Eligard	leuprolide acetate subcutaneous injection - Tolmar
Lutrate Depot	leuprolide acetate 22.5 mg for depot suspension - Avyxa Pharma
Trelstar	triptorelin pamoate intramuscular injection - Verity
Vabrinty	leuprolide acetate subcutaneous injection (Eligard authorized generic) - Tolmar
Firmagon	degarelix subcutaneous injection - Ferring

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of the listed agents; approvals are provided for the durations noted (generally 1 year). Automation: None.

Documentation Required

Specialist prescriber requirement

Agent must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist or urologist as specified per indication).

Billing Rule

Dosing must match policy-listed frequencies

Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician; approvals are limited to the dosing and frequency options listed in the policy.

Prior Authorization

Approval duration

Approvals for prostate cancer and other listed indications are for 1 year; extended approvals are allowed if the patient continues to meet the criteria and dosing.

Clinical Evidence & Guideline References

Evidence and guideline context referenced in the policy include the National Comprehensive Cancer Network (NCCN) guidelines: NCCN Prostate Cancer guideline version 4.2026 (Dec 4, 2025) and NCCN Breast Cancer guideline version 1.2026 (Jan 16, 2026).

The policy includes supportive-evidence approvals consistent with NCCN guidance for breast cancer (ovarian suppression with GnRH agonists in premenopausal patients) and for androgen receptor-positive salivary gland tumors (androgen receptor therapy with GnRH agents noted as 'Useful in Certain Circumstances').

Background

Background: This policy governs use of multiple GnRH analogs — both GnRH agonists and the GnRH receptor antagonist Firmagon (degarelix) — that are primarily indicated for the treatment of advanced prostate cancer.

The policy also provides supportive-evidence approvals for other indications per NCCN guidance, specifically for breast cancer (use of GnRH agonists for ovarian suppression in premenopausal patients) and for androgen receptor-positive salivary gland tumors (androgen receptor therapy including leuprolide or triptorelin noted as useful in certain circumstances).

Policy statistics

Agents covered7

Covered indications3 (Prostate, Breast, Head & Neck - Salivary)

Typical approval duration1 year

Definitions:

Vabrinty — Eligard authorized generic.

Firmagon — GnRH receptor antagonist (degarelix).

Revision History

01/17/2024review