Subject: Fibryga 2989-A SGM P2024

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 Selected Disorders of the Coagulation System. Revised August 2023. MASAC Document #280. https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-280-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-selected-disorders-of-the-coagulation-system. Accessed October 4, 2023.

 

 

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 17, 2024