Subject: Obizur SGM 1948-A P2025

Drug

OBIZUR  (antihemophilic factor [recombinant], porcine sequence)

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

Obizur is indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A.

Limitations of Use

• Safety and efficacy of Obizur has not been established in patients with a baseline anti-porcine factor VIII inhibitor titer of greater than 20 Bethesda units (BU).
• Obizur is not indicated for the treatment of von Willebrand disease.

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

Prescriber Specialties

Must be prescribed by or in consultation with a hematologist.

Coverage Criteria

Acquired hemophilia A^1-3

Authorization of 1 month may be granted for treatment of acquired hemophilia A.

Continuation of Therapy

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

Place of Service:

Outpatient

The above policy is based on the following references:

1. Obizur [package insert]. Lexington, MA: Takeda Pharmaceucticals U.S.A., Inc.; March 2023.
2. National Hemophilia Foundation. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System. Revised October 2024. MASAC Document #290. https://www.hemophilia.org/sites/default/files/document/files/MASAC-Products-Licensed.pdf. Accessed December 10, 2024.
3. Gomperts E. Recombinant B domain deleted porcine factor VIII for the treatment of bleeding episodes in adults with acquired hemophilia A. Expert Review of Hematology. 2015 Aug;8(4):427-32.

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