Firmagon (degarelix) coverage and prior authorization
Customize your policy alerts
Sign up for Viva Health Policy IC-0044 alerts
Get alerted when Policy IC-0044 changes without checking for updates manually.
Monitor payer policy activity
Policy governing prior authorization, dosing, and coverage criteria for Firmagon (degarelix) for treatment of prostate cancer for Viva Health members age 18 and older.
No material clinical or coverage changes in this revision.
Coverage criteria for Firmagon (degarelix)
Initial Therapy
Covered when ALL of the following are met:
Initial Approval for Prostate Cancer
- Age: Member is at least 18 years of age
- Indication: Prostate cancer per FDA-approved or compendia-recommended indications
Max units: 240 units for starting dose; 80 units every 28 days for maintenance.
Continuation Therapy / Renewal
Renewal approved when ALL of the following are met:
Examples of unacceptable toxicity include QT interval prolongation and severe hypersensitivity reactions.
Renewal of prior authorization is contingent on evidence that the member continues to meet the indication-specific criteria and demonstrates disease response to treatment, defined as stabilization of disease or a decrease in tumor size or spread. Renewal will not be approved if there is evidence of unacceptable toxicity attributed to degarelix. Examples of such unacceptable toxicities explicitly cited in the policy include QT interval prolongation and severe hypersensitivity reactions.
This policy limits coverage to the prostate cancer indications described in the document and supporting references. The policy does not include explicit statements authorizing coverage for other, non‑listed indications; therefore payor coverage is confined to the indicated prostate cancer diagnoses and the associated prior authorization criteria outlined in the policy.
Billing and coding references
| J9155 | Injection, degarelix, 1 mg; 1 billable unit = 1 mg |
| C61 | Malignant neoplasm of prostate |
| Z85.46 | Personal history of malignant neoplasm of prostate |
| 55566-8303-xx | Firmagon 80 mg single-dose vial powder for injection Maintenance Dose Kit |
| 55566-8403-xx | Firmagon 120 mg single-dose vials (2) powder for injection Starting Dose Kit |
What providers must do
Prior authorization duration and renewal
Prior authorization is required. Initial approval is provided for 6 months (180 days) and may be renewed every 6 months (180 days) thereafter when renewal criteria are met.
- Initial: prior authorization validity will be provided initially for 6 months (180 days).
- Renewal: prior authorization validity may be renewed every 6 months (180 days) thereafter.
Step therapy not required
No step therapy (no required trials of alternative therapies) is specified in this policy.
Required documentation to support PA
Include documentation of the covered diagnosis (ICD-10 C61 or Z85.46), the dosing administered tied to HCPCS J9155 units (J9155 = injection, degarelix, 1 mg; 1 billable unit = 1 mg), and the NDC when applicable (starting and maintenance kit NDCs).
- Covered diagnosis codes: C61 (malignant neoplasm of prostate) or Z85.46 (personal history of malignant neoplasm of prostate).
- HCPCS J9155 corresponds to degarelix dosing by mg (1 unit = 1 mg).
- NDCs: 55566-8403-xx (starting dose kit) and 55566-8303-xx (maintenance dose kit).
Denial risks and triggers
Prior authorization may be denied if the member does not meet the age requirement (must be at least 18) or does not meet the indication criteria; utilization management considerations such as cost-driven PA requirements also apply.
- Member must be at least 18 years of age.
- Indication must be prostate cancer per FDA-approved or compendia-recommended indications.
- Utilization management (e.g., cost considerations) is a factor in applying prior authorization.
Clinical background
Degarelix is a gonadotropin‑releasing hormone (GnRH) receptor antagonist used in the management of prostate cancer. The policy references the FDA‑approved product labeling and the NCCN Drugs & Biologics Compendium as supporting sources for the labeled indications and recommended use, including dosing and monitoring considerations.
Referenced compendia and sources
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.