Subject: Factor IX 1944-A SGM P2022

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, MONONINE  (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.; October 2020.
2. BeneFIX [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; September 2021.
3. Ixinity [package insert]. Seattle, WA: Aptevo BioTherapeutics LLC, February 2021.
4. Rixubis [package insert]. Lexington, MA: Baxalta US Inc.; June 2020.
5. AlphaNine SD [package insert]. Los Angeles, CA: Grifols Biologicals LLC; February 2021.
6. Mononine [package insert]. Kankakee, IL: CSL Behring LLC; December 2020.
7. Idelvion [package insert]. Kankakee, IL: CSL Behring LLC; July 2021.
8. Rebinyn [package insert]. DK-2880 Bagsvaerd, Denmark: Novo Nordisk A/S; June 2020.
9. 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.
10. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. Revised August 2020. MASAC Document #263. https://www.hemophilia.org/sites/default/files/document/files/263_treatment.pdf. Accessed December 7, 2021.

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.

May 16, 2022