Subject: Fibryga 2989-A SGM P2021

Drug

FIBRYGA®  (fibrinogen [human])

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.

         FDA-Approved Indication
         Fibryga is indicated in adults and adolescents with congenital fibrinogen deficiency, including
         afibrinogenemia and hypofibrinogenemia, for the treatment of acute bleeding episodes.

         Fibryga is not indicated for dysfibrinogenemia.

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

  II.   CRITERIA FOR INITIAL APPROVAL

         Fibrinogen Deficiency
         Authorization of 1 month may be granted for treatment of acute bleeding episodes in
         members with a diagnosis of congenital fibrinogen deficiency, including afibrinogenemia
         and hypofibrinogenemia.
 
 III.   CONTINUATION OF THERAPY   
 
         All members (including new members) requesting authorization for continuation of therapy
         must meet all initial authorization criteria.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Fibryga [package insert]. Hoboken, NJ: Octapharma USA, Inc.; September 2017.
2. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. Revised August 2020. MASAC Document #263. https://www.hemophilia.org/sites/default/files/document/files/263_treatment.pdf. Accessed October 14, 2020. 

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.

May 27, 2021