Subject: Sevenfact 3760-A SGM P2023

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:
               º    > 5 BU/mL
               º    Inhibitors act strongly and quickly neutralize factor

          •    Low-titer inhibitors:
               º< 5 BU/mL
               ºInhibitors act weakly and slowly neutralize factor

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sevenfact [package insert]. Les Ulis, France: Laboratoire Francais du Fractionnement et des Biotechnologies S.A. (LFB S.A.); April 2020.
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 other bleeding disorders. Revised March 2022. MASAC Document #272. https://www.hemophilia.org/sites/default/files/document/files/272_Treatment.pdf. Accessed December 2, 2022.

 

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 15, 2023