CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization, approved indications, and dosing criteria for medical-benefit coverage of Camcevi, Eligard, Leuprolide Depot, Trelstar, and Firmagon for advanced prostate cancer and androgen receptor-positive salivary gland tumors (head and neck). Specifies prescribing clinician specialty and approval durations.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revision (no material criteria changes)

Effective DateJan 22, 2025

Next Review Date

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with an oncologist or urologist; approvals are granted per criteria and dosing for 1 year.

SourceLink

POLICY UPDATE CHANGES

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

Trelstar was previously added to approval criteria and dosing (historical change).

2Covered Indications

5Named Agents

1Std Approval (yrs)

Coverage Summary

This policy defines prior authorization and utilization management criteria for GnRH analogs (Camcevi, Eligard, Leuprolide Depot, Trelstar, Firmagon) and is covered with criteria for specified indications. Status: CURRENT. Effective/Last review date: 2025-01-22. Approvals are generally granted for 1 year and require the medication to be prescribed by or in consultation with an oncologist or urologist for prostate cancer (prescriber specialty requirements detailed in the policy).

The policy covers 2 named indications and identifies 5 named agents; the standard approval duration is 1 year per the listed criteria and dosing requirements.

Policy Metadata

Policy TitleGnRH analogs (Camcevi, Eligard, Leuprolide Depot, Trelstar, Firmagon) utilization management

PayerCareSource

Policy NumberN/A

Effective Date2025-01-22

Last Review2025-01-22

Next Review

Coverage Stancecovered_with_criteria

Recommended Authorization Criteria

FDA-Approved Indication (Prostate Cancer)

Approve for 1 year if prescribed by or in consultation with an oncologist or urologist. Approve ONE of the following doses:

ALL of the following

Indication: Prostate Cancer
Approve for 1 year if prescribed by or in consultation with an oncologist or urologist.
Dose - select ONE
- Camcevi 42 mg: Camcevi: 42 mg administered as a subcutaneous injection not more frequently than once every 6 months.
- Eligard 7.5 mg: Eligard: 7.5 mg subcutaneous injection not more frequently than once every month.
- Eligard 22.5 mg: Eligard: 22.5 mg subcutaneous injection not more frequently than once every 3 months.
- Eligard 30 mg: Eligard: 30 mg subcutaneous injection not more frequently than once every 4 months.
- Eligard 45 mg: Eligard: 45 mg subcutaneous injection not more frequently than once every 6 months.
- Firmagon starting 240 mg: Firmagon: Starting dose 240 mg administered as two subcutaneous injections of 120 mg.
- Firmagon maintenance 80 mg: Firmagon: Maintenance dose up to 80 mg administered as one subcutaneous injection not more frequently than once every 28 days (first maintenance dose given 28 days after starting dose).
- Trelstar 3.75 mg: Trelstar: 3.75 mg intramuscular injection not more frequently than once every 4 weeks.
- Trelstar 11.25 mg: Trelstar: 11.25 mg intramuscular injection not more frequently than once every 12 weeks.
- Trelstar 22.5 mg: Trelstar: 22.5 mg intramuscular injection not more frequently than once every 24 weeks.
- Leuprolide Depot 22.5 mg: Leuprolide Depot: 22.5 mg intramuscular injection not more frequently than once every 3 months.

Other Uses with Supportive Evidence (Head and Neck Cancer - Salivary Gland Tumors)

Approve for 1 year if the patient meets ALL of the following and medication is prescribed by or in consultation with an oncologist.

ALL of the following

Clinical criteria: Patient has recurrent, unresectable, or metastatic disease.
Biomarker: Patient has androgen receptor-positive disease.
Prescriber: Medication is prescribed by or in consultation with an oncologist.
Dose - select ONE
- Camcevi 42 mg:

Conditions Not Recommended for Approval

Coverage is not recommended when criteria below are not met.

ALL of the following

Not recommended: Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Named Agents (drug list)

Drugs named in policy (no codes provided in document)mixed

Camcevi	leuprolide subcutaneous injection - Accord BioPharma (42 mg every 6 months)
Eligard	leuprolide acetate subcutaneous injection - Tolmar (7.5 mg monthly; 22.5 mg Q3M; 30 mg Q4M; 45 mg Q6M)
Firmagon	degarelix subcutaneous injection - Ferring (starting 240 mg (2x120 mg); maintenance 80 mg Q28 days)
Leuprolide Depot	leuprolide acetate 22.5 mg for depot suspension - Cipla USA (22.5 mg Q3M)
Trelstar	triptorelin pamoate intramuscular injection - Verity (3.75 mg Q4W; 11.25 mg Q12W; 22.5 mg Q24W)

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical-benefit coverage of the listed agents. Approvals are granted per the policy criteria and the specified dosing for each product.

Camcevi
Eligard
Leuprolide Depot
Trelstar
Firmagon

Documentation Required

Prescriber specialty/documentation requirement

The medication must be prescribed by or in consultation with a physician who specializes in the condition being treated. For prostate cancer this may be an oncologist or a urologist; for head and neck salivary gland tumors the medication must be prescribed by or in consultation with an oncologist.

Prostate cancer: oncologist or urologist
Head and neck (salivary gland tumors): oncologist

Documentation Required

Approval duration and continuation

Approvals are provided for 1 year. Extended approvals are allowed if the patient continues to meet the policy criteria and dosing. Requests for doses outside the established dosing in this policy will be reviewed on a case-by-case basis by a clinician.

Background & Evidence

GnRH agonists (Camcevi, Eligard, Leuprolide Depot, Trelstar) and the GnRH antagonist (Firmagon) are indicated for treatment of advanced prostate cancer; select agents (for example leuprolide formulations and Trelstar) are also supported by NCCN guidance for androgen receptor–positive salivary gland tumors. Recommended FDA dosages are specified for each product in the policy dosing tables and authorization criteria.

Source	Summary/Note
NCCN Prostate Cancer Guidelines	Version 1.2025 - androgen deprivation therapy recommended for regional/advanced disease and in combination with radiation for localized/locally advanced disease.
NCCN Head and Neck Guidelines	Version 2.2025 - androgen receptor therapy noted as 'Useful in Certain Circumstances' for AR-positive salivary gland tumors.

GnRH agonist: Gonadotropin-releasing hormone agonist (e.g., leuprolide, triptorelin) used for androgen deprivation.

GnRH antagonist: Gonadotropin-releasing hormone receptor antagonist (e.g., degarelix) used for androgen deprivation.

Revision History

01/22/2025change_addedLatest

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

01/17/2024annual_revision

Annual Revision noted: No criteria changes.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revision (no material criteria changes)

Effective DateJan 22, 2025

Next Review Date

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with an oncologist or urologist; approvals are granted per criteria and dosing for 1 year.

SourceLink

On This Page

Camcevi: 42 mg subcutaneous injection not more frequently than once every 6 months.

Eligard 7.5 mg: Eligard: 7.5 mg subcutaneous injection not more frequently than once every month.

Eligard 22.5 mg: Eligard: 22.5 mg subcutaneous injection not more frequently than once every 3 months.

Eligard 30 mg: Eligard: 30 mg subcutaneous injection not more frequently than once every 4 months.

Eligard 45 mg: Eligard: 45 mg subcutaneous injection not more frequently than once every 6 months.

Trelstar 3.75 mg: Trelstar: 3.75 mg intramuscular injection not more frequently than once every 4 weeks.

Trelstar 11.25 mg: Trelstar: 11.25 mg intramuscular injection not more frequently than once every 12 weeks.

Trelstar 22.5 mg: Trelstar: 22.5 mg intramuscular injection not more frequently than once every 24 weeks.