Subject: Fibryga 2989-A SGM P2023

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 for the treatment of acute bleeding episodes
          in adults and children with congenital fibrinogen deficiency,
          including afibrinogenemia and hypofibrinogenemia.

          Fibryga is not indicated for dysfibrinogenemia.

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

 
    II.  CRITERIA FOR INITIAL APPROVAL

          Congenital 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]. Paramus, NJ: Octapharma USA, Inc.; December 2020.
2. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. Revised April 2022. MASAC Document #272. https://www.hemophilia.org/sites/default/files/document/files/272_Treatment.pdf. Accessed September 22, 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.

April 15, 2023