CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization recommendation, approved indications, dosing, prescriber requirements, and non-covered situations for Camcevi, Eligard, Leuprolide Depot (Lutrate Depot), Firmagon, and Trelstar when used for oncology indications (primarily advanced prostate cancer and select head and neck salivary gland tumors). Applies to medical-benefit coverage and specifies duration of approval.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revisionno criteria changes (this cycle)prior addition of Trelstar for salivary gland tumors

Effective Date01/22/2025

Next Review Date

Key ActionPrior Authorization is recommended for medical benefit coverage of Camcevi, Eligard, Leuprolide Depot, Trelstar, and Firmagon; approve for 1 year if prescribed by or in consultation with an oncologist or urologist.

SourceLink

POLICY UPDATE CHANGES

Annual Revision notes: No criteria changes for this revision cycle.

Head and Neck Cancer Salivary Gland Tumors: Previously (prior year) Trelstar was added to approval criteria and dosing.

5Agents listed

2Covered indications

1Approval duration (years)

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Overview: This policy addresses gonadotropin-releasing hormone (GnRH) analogs used in oncology and applies to medical-benefit coverage. Covered agents include GnRH agonists Camcevi, Eligard, Leuprolide Depot (formerly Lutrate Depot), and Trelstar, and the GnRH receptor antagonist Firmagon. Primary covered indications are treatment of advanced prostate cancer, with select head and neck salivary gland tumors (androgen receptor–positive recurrent, unresectable, or metastatic disease) supported per guideline references. A dosing and route table is provided in the policy specifying approved routes (subcutaneous or intramuscular) and dosing frequencies for each agent (for example, Camcevi 42 mg subcutaneous every 6 months; Eligard 7.5 mg subcutaneous monthly, 22.5 mg q3 months, 30 mg q4 months, or 45 mg q6 months; Leuprolide Depot 22.5 mg intramuscular q3 months; Firmagon starting 240 mg (2×120 mg) subcutaneously then maintenance up to 80 mg q28 days; Trelstar intramuscular 3.75 mg q4 weeks, 11.25 mg q12 weeks, or 22.5 mg q24 weeks).

Coverage stance: covered_with_criteria. Approval duration when criteria are met: 1 year.

Key Facts

Approval duration1 year

Prescriber requirementOncologist or Urologist involvement required

Benefit typeMedical benefit

Coding (Medical Benefit Agents)

Drugs covered under this policy (medical benefit agents listed)mixedCovered

	Camcevi (leuprolide subcutaneous injection Accord BioPharma) - doses: 42 mg q6 months; 7.5 mg q1 month
	Eligard (leuprolide acetate subcutaneous injection Tolmar) - doses: 7.5 mg q1 month; 22.5 mg q3 months; 30 mg q4 months; 45 mg q6 months
	Leuprolide Depot (leuprolide acetate 22.5 mg for depot suspension Cipla USA) - 22.5 mg q3 months (IM)
	Firmagon (degarelix subcutaneous injection Ferring) - starting dose 240 mg (2x120 mg); maintenance up to 80 mg q28 days
	Trelstar (triptorelin pamoate IM injection Verity) - doses: 3.75 mg q4 weeks; 11.25 mg q12 weeks; 22.5 mg q24 weeks

Provider Actions & Billing Guidance

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of Camcevi, Eligard, Leuprolide Depot, Trelstar, and Firmagon. Approvals are for 1 year when prescribed by or in consultation with an oncologist or urologist.

Camcevi
Eligard
Leuprolide Depot
Trelstar
Firmagon

Documentation Required

Specialist involvement required

Approval requires the agent to be prescribed by or in consultation with a physician who specializes in the condition treated (e.g., an oncologist or urologist).

Billing Rule

Dosing frequency constraints

Approve only at the specified dosing frequencies for each agent as listed in the policy.

Camcevi: 42 mg injection not more frequently than once every 6 months; (also lists 7.5 mg injection not more frequently than once every month)
Eligard: 7.5 mg injection not more frequently than once every month; 22.5 mg injection not more frequently than once every 3 months; 30 mg injection not more frequently than once every 4 months; 45 mg injection not more frequently than once every 6 months
Leuprolide Depot: 22.5 mg injection not more frequently than once every 3 months
Firmagon: Starting dose 240 mg given as two injections of 120 mg; maintenance dose up to 80 mg as one injection given every 28 days (first maintenance dose given 28 days after starting dose)
Trelstar: 3.75 mg injection not more frequently than once every 4 weeks; 11.25 mg injection not more frequently than once every 12 weeks; 22.5 mg injection not more frequently than once every 24 weeks

Documentation Required

Off-label or non-standard dosing requests

Requests for doses outside of the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Background & Evidence

Background: The policy covers both classes of agents: GnRH agonists (Camcevi, Eligard, Leuprolide Depot, and Trelstar) and the GnRH receptor antagonist (Firmagon). These agents are typically used as androgen deprivation therapy in oncology, primarily for advanced prostate cancer, as described in guidelines. National Comprehensive Cancer Network guidance also notes supportive evidence for use of androgen receptor–directed therapy (including leuprolide and Trelstar among others) for recurrent, unresectable, or metastatic androgen receptor–positive salivary gland tumors of the head and neck in certain circumstances. The policy includes a table of approved routes and dosing frequencies for each agent.

Reference	Notes
NCCN Prostate Cancer Guideline	References androgen deprivation therapy including listed agents; version 1.2025; accessed Jan 17, 2025
NCCN Head and Neck Cancer Guideline	Notes androgen receptor therapy for recurrent/unresectable/metastatic androgen receptor–positive salivary gland tumors; version 2.2025; accessed Jan 17, 2025