Subject: Fibryga SGM 2989-A P2025

Drug

FIBRYGA  (fibrinogen [human])

Policy:

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 Indications¹

Fibryga is indicated for:

• Fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency.
• The treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Limitation of use

Fibryga is not indicated for dysfibrinogenemia.

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

Coverage Criteria

Congenital Fibrinogen Deficiency^1,2

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.

Acquired Fibrinogen Deficiency¹

Authorization of 1 month may be granted for treatment of bleeding episodes in members with a diagnosis of acquired fibrinogen deficiency.

Continuation of Therapy

All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria section.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Fibryga [package insert]. Paramus, NJ: Octapharma USA, Inc.; July 2024.
2. National Hemophilia Foundation. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System. Revised April 2024. MASAC Document #284. https://www.bleeding.org/sites/default/files/document/files/MASAC-Products-Licensed.pdf. Accessed October 15, 2024.

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 20, 2025