Subject: Tretten 2985-A SGM P2023

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 other bleeding disorders. Revised March 2022. MASAC Document #272. https://www.hemophilia.org/sites/default/files/document/files/272_Treatment.pdf. Accessed October 4, 2022.

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 15, 2023