Subject: Tretten SGM 2985-A P2025

Drug

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

Policy:

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 Indications¹

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.

Coverage Criteria

Congenital Factor XIII A-Subunit Deficiency^1-2

Authorization of 12 months may be granted for prophylaxis of bleeding in members with congenital factor XIII A-subunit deficiency.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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 April 2024. MASAC Document #284. https://www.bleeding.org/sites/default/files/document/files/MASAC-Products-Licensed.pdf. Accessed October 16, 2024.https://www.bleeding.org/sites/default/files/document/files/MASAC-Products-Licensed.pdf.

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 20, 2025