Subject: Tretten 2985-A SGM P2024

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 for routine prophylaxis of bleeding in patients with congenital factor XIII A-
          subunit deficiency.

          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 prophylaxis of bleeding in members with
          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 Selected Disorders of the Coagulation System. Revised August 2023. MASAC Document #280. https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-280-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-selected-disorders-of-the-coagulation-system. Accessed October 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