Subject: Sevenfact 3760-A SGM P2024

Drug

SEVENFACT  (coagulation factor VIIa [recombinant]-jncw)

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 Indications
          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.

          Limitation 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.


    II.  EXCLUSIONS

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


   III.  CRITERIA FOR INITIAL APPROVAL

          A.  Hemophilia A with Inhibitors
               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.

          B.  Hemophilia B with Inhibitors
                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.


   IV.  CONTINUATION OF THERAPY

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

    V.  APPENDIX

          Appendix: Inhibitors - Bethesda Units (BU)
         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.); November 2022.
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 August 2023. MASAC Document #280. https://www.hemophilia.org/sites/default/files/document/files/MASAC-Products-Licensed.pdf. Accessed December 8, 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