Subject: Tretten 2985-A SGM P2021

Drug

TRETTEN®  (coagulation Factor XIII A-Subunit [recombinant])

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
       Tretten is indicated in patients with congenital factor XIII A-subunit deficiency for routine
       prophylaxis for bleeding.

       Tretten is not for use in patients with congenital factor XIII B-subunit deficiency.

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

 II.   CRITERIA FOR INITIAL APPROVAL

        Congenital Factor XIII A-Subunit Deficiency
        Authorization of 12 months may be granted for prophylactic treatment of congenital factor XIII
        A-subunit deficiency.
 
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).

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tretten [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; June 2020.|
2. 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.

 

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 27, 2021