FIRMAGON, Degarelix Acetate Form

Degarelix acetate (Firmagon®) is a gonadotropin-releasing hormone (GnRH) receptor antagonist. FDA Approved Indication(s) Firmagon is indicated for treatment of advanced prostate cancer. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Firmagon is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Prostate Cancer (must meet all):

1. Diagnosis of prostate cancer;
2. Prescribed by or in consultation with an oncologist or urologist;
3. Age ≥ 18 years;

4. Request meets one of the following (a, b, or c): a. Starting dose does not exceed 240 mg given as two injections of 120 mg each; b. Maintenance dose does not exceed 80 mg as a single injection per 28 days; c. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration:
   HIM/Medicaid – 12 months Commercial – 6 months or to member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Degarelix Acetate b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Prostate Cancer (must meet all):
   3. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Firmagon for prostate cancer and has received this medication for at least 30 days;
   4. Member is responding positively to therapy;

5. If request is for a dose increase, request meets one of the following: a. New dose does not exceed 80 mg as a single injection per 28 days; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration:
   HIM/Medicaid – 12 months Commercial – 6 months or to member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – Page 2 of 5

   CLINICAL POLICY Degarelix Acetate CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration GnRH: gonadotropin-releasing hormone
   NCCN: National Comprehensive Cancer Network Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): previous hypersensitivity reactions to degarelix • Boxed warning(s): none reported V. Dosage and Administration
   Indication Prostate cancer Dosing Regimen Starting dose: 240 mg SC given as two 120 mg injections Maintenance dose: 80 mg SC given as one injection per 28 days Maximum Dose See regimen VI. Product Availability
   Vial: 80 mg (20 mg/mL), 120 mg (40 mg/mL) VII.