Subject: Firmagon 2147-A SGM P2022

Drug

FIRMAGON  (degarelix)

Policy:

       I.  INDICATIONS
           The indications below including FDA-approved indications and
           compendial uses are considered a covered benefit provided that
           all the approval criteria are met and the member has no
           exclusions to the prescribed therapy.

           A.  FDA-Approved Indication
                Firmagon is indicated for the treatment of advanced
                prostate cancer.

           B.  Compendial Uses
                Prostate cancer

           All other indications are considered experimental/investigational
           and not medically necessary.

 
     II.  CRITERIA FOR INITIAL APPROVAL
           Authorization of 12 months may be granted for treatment of
           prostate cancer.

 
    III. CONTINUATION OF THERAPY
           Authorization of 12 months may be granted for continued
           treatment in members requesting reauthorization who are
           experiencing clinical benefit to therapy (e.g., serum
           testosterone less than 50 ng/dL) and who have not experienced
           an unacceptable toxicity.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Firmagon [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; February 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed February 1, 2022.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 24, 2022