Subject: FEIBA 1943-A SGM P2021

Drug

FEIBA®  (anti-inhibitor coagulant complex [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. 

 A.   FDA-Approved Indication
       Hemophilia A and hemophilia B with inhibitors 

 B.   Compendial Use
       Acquired hemophilia A

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

II.   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 if the patient 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 if the patient has a history of an inhibitor titer ≥ 5 BU. 

 C.   Acquired Hemophilia A
       Authorization of 12 months may be granted for treatment of acquired hemophilia A. 

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

Special Notes:

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. FEIBA [package insert]. Lexington, MA: Baxalta US Inc.; February 2020.
2. AHFS DI (Adult and Pediatric) [database online]. Hudson, OH: Lexi-Comp, Inc.; https://online.lexi.com/lco/action/doc/retrieve/docid/essential_ashp/988283 [available with subscription]. Accessed November 25, 2020.
3. Acquired hemophilia. World Federation of Hemophilia. http://www1.wfh.org/publications/files/pdf-1186.pdf. Accessed November 25, 2020.
4. Tiede A, Collins P, Knoebl P, et al. International recommendations on the diagnosis and treatment of acquired hemophilia A. Haematologica. 2020;105(7):1791-1801. doi:10.3324/haematol.2019.230771.
5. Franchini M, Mannucci PM. Acquired haemophilia A: a 2013 update. Thromb Haemost. 2013;110(6):1114-20.
6. 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 November 20, 2020.
7. 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.
8. National Hemophilia Foundation. MASAC recommendations regarding prophylaxis with bypassing agents in patients with hemophilia and high titer inhibitors. MASAC Document #220. https://www.hemophilia.org/sites/default/files/document/files/masac220.pdf. Accessed November 25, 2020.
9. Kruse-Jarres, R, Kempton CL, Baudo, F, et al. Acquired hemophilia A: Updated review of evidence and treatment guidance. Am J Hematol. 2017;92:695-705.

    

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 12, 2021