Subject: Sevenfact SGM 3760-A P2025

Drug

SEVENFACT  (coagulation factor VIIa [recombinant]-jncw)

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

Sevenfact is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.

Limitations of Use

Sevenfact is not indicated for the treatment of patients with congenital Factor VII deficiency.

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

Exclusions

Coverage will not be provided for members less than 12 years of age.

Coverage Criteria

Hemophilia A with Inhibitors^1,2

Authorization of 12 months may be granted for treatment of hemophilia A with inhibitors (see Appendix) when the inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL) or the member has a history of an inhibitor titer ≥ 5 BU.

Hemophilia B with Inhibitors^1,2

Authorization of 12 months may be granted for treatment of hemophilia B with inhibitors (see Appendix) when the inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL) or the member has a history of an inhibitor titer ≥ 5 BU.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when the member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds).

Appendix

Appendix: Inhibitors - Bethesda Units (BU)²

The presence of inhibitors is confirmed by a specific blood test called the Bethesda inhibitor assay.

• High-titer inhibitors:
  • ≥ 5 BU/mL
  • Inhibitors act strongly and quickly neutralize factor
• Low-titer inhibitors:
  • < 5 BU/mL
  • Inhibitors act weakly and slowly neutralize factor

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sevenfact [package insert]. Puteaux, France: Laboratoire Francais du Fractionnement et des Biotechnologies S.A. (LFB S.A.); June 2024.
2. Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020;26 Suppl 6:1-158. doi:10.1111/hae.14046.
3. 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 11, 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