Subject: Factor IX 1944-A SGM P2024

Drug

REBINYN  (coagulation factor IX [recombinant], glycoPEGylated)

IDELVION  (coagulation factor IX [recombinant], albumin fusion protein)

ALPROLIX  (coagulation factor IX [recombinant], Fc fusion protein)

BENEFIX, IXINITY, RIXUBIS  (coagulation factor IX [recombinant])

ALPHANINE SD  (coagulation factor IX [human])

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 Indication
          Hemophilia B

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


     II.  PRESCRIBER SPECIALTIES

          Must be prescribed by or in consultation with a hematologist.


    III.  CRITERIA FOR INITIAL APPROVAL

          Hemophilia B
          Authorization of 12 months may be granted for treatment of hemophilia B.


   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).

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Alprolix [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.; May 2023.
2. BeneFIX [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals LLC; November 2022.
3. Ixinity [package insert]. Chicago, IL: Medexus Pharma, Inc.; November 2022.
4. Rixubis [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; March 2023.
5. AlphaNine SD [package insert]. Los Angeles, CA: Grifols Biologicals LLC; November 2022.
6. Idelvion [package insert]. Kankakee, IL: CSL Behring LLC; June 2023.
7. Rebinyn [package insert]. DK-2880 Bagsvaerd, Denmark: Novo Nordisk A/S; August 2022.
8. 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.
9. 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 5, 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