CurrentHealth NetPolicy CP PHAR.170

Degarelix Acetate (Firmagon)

Policy governs medical necessity and prior authorization criteria for degarelix acetate (Firmagon) for members of Health Net/Centene-affiliated plans (Commercial, HIM, Medicaid). It specifies indications, dosing limits, prescriber requirements, and duration of approval.

Policy Summary

PayerHealth Net

PolicyDegarelix Acetate (Firmagon)

Policy CodePolicy CP PHAR.170

Change TypeNo material changes

Effective DateOct 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

240Maximum starting dose (two injections of 120 mg)

80Maximum maintenance dose (per 28 days)

J9155HCPCS code for degarelix

6 moTypical approval duration (Commercial)

12 moTypical approval duration (HIM/Medicaid)

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Medical Necessity Criteria for Degarelix (Firmagon)

Initial Approval Criteria - Prostate Cancer

Firmagon is medically necessary when ALL of the following are met for prostate cancer:

ALL of the following

Diagnosis of prostate cancer.
Prescribed by or in consultation with an oncologist or urologist.
Patient age is >= 18 years.>= 18 years
Starting dose does not exceed 240 mg given as two injections of 120 mg each.<= 240 mg (2 x 120 mg)
Maintenance dose does not exceed 80 mg as a single injection per 28 days.<= 80 mg per 28 days
Prescribed regimen must be FDA-approved or recommended by NCCN; for off-label uses dose must be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

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Initial Approval Criteria - Other Diagnoses/Indications

For diagnoses/indications other than prostate cancer:

ANY of the following

If drug is on formulary/PDL for the line of business, follow the applicable no-coverage criteria policy for the relevant line of business (see related policies).
If drug is NOT on formulary/PDL for the line of business, follow the applicable non-formulary policy for the relevant line of business (see related policies).
If the requested use is not listed and criterion 1 (diagnosis) above does not apply, refer to the off-label use policy for the relevant line of business.

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Continuation (Renewal) Criteria - Prostate Cancer

Continued therapy is medically necessary when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit; or documentation supports member has received Firmagon for prostate cancer for at least 30 days.
Member is responding positively to therapy (clinical response documented).
New maintenance dose does not exceed 80 mg as a single injection per 28 days.<= 80 mg per 28 days
If request is for a dose increase, the new dose must be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Not Authorized / Exclusions

Coverage is NOT authorized for:

ANY of the following

Non-FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided according to the applicable off-label use policy.
Use inconsistent with formulary/non-formulary or off-label policies referenced in related policies.

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Prior Authorization & Documentation Requirements

Documentation Required

Submit supporting documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) that supports the member has met all approval criteria for Firmagon prior to authorization.

Examples include office notes, laboratory results, and other clinical information demonstrating diagnosis, age, dosing, and treatment response as required by the criteria.
Documentation should specifically address all elements of the applicable approval criteria (e.g., diagnosis of prostate cancer, prescriber specialty, dosing limits).

Prior Authorization

Prescriber specialty requirement

Initial prescription must be written by an oncologist or urologist, or written in consultation with an oncologist or urologist, to meet the policy's approval criteria.

Ensure the prescribing clinician is documented as an oncologist or urologist or that consultation with one is documented in the chart.

Prior Authorization

Off-label dosing/supporting evidence

When requesting off‑label uses or dose increases, the prescriber must submit supporting practice guideline or peer‑reviewed literature evidence justifying the requested dose or regimen.

For initial requests: provide practice guideline or peer‑reviewed literature if dose/regimen is outside the FDA‑approved parameters.
For continuation requests that seek a dose increase: submit practice guideline or peer‑reviewed literature supporting the new dose.

Denial Risk

Exclusion for non‑FDA indications without evidence

Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided in accordance with the applicable off‑label use policy.

Refer to the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) for the required evidence standards.
Absence of adequate efficacy/safety documentation per those policies is a basis for denial.

Clinical Background & Policy Scope

Background: Degarelix acetate (Firmagon) is a GnRH receptor antagonist indicated for treatment of advanced prostate cancer. The FDA‑recommended dosing is a starting dose of 240 mg subcutaneously (given as two 120 mg injections) followed by a maintenance dose of 80 mg subcutaneously every 28 days.

Scope: This policy governs medical necessity and prior authorization criteria for degarelix acetate (Firmagon) for members of Health Net/Centene‑affiliated plans (Commercial, Health Insurance Marketplace/HIM, and Medicaid). It specifies covered indications, dosing limits, prescriber specialty requirements, documentation expectations, and duration of approval across the applicable lines of business.

OpenPayer

Degarelix Acetate (Firmagon)

Medical Necessity Criteria for Degarelix (Firmagon)

Relevant Billing Codes

Prior Authorization & Documentation Requirements

Clinical Background & Policy Scope

Defined Terms

Dose & Eligibility Thresholds

Policy Dates

Degarelix Acetate (Firmagon)

Medical Necessity Criteria for Degarelix (Firmagon)

Relevant Billing Codes

Prior Authorization & Documentation Requirements

Clinical Background & Policy Scope

Defined Terms

See Also

Dose & Eligibility Thresholds

Policy Dates