Subject: Coagadex SGM 1942-A P2025

Drug

COAGADEX  (coagulation Factor X [human])

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

Coagadex is indicated in adults and children with hereditary Factor X deficiency for:

• Routine prophylaxis to reduce the frequency of bleeding episodes.
• On-demand treatment and control of bleeding episodes.
• Perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency.

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

Coverage Criteria

Hereditary Factor X Deficiency^1-4

• Authorization of 12 months may be granted for prophylaxis to reduce the frequency of bleeding episodes.
• Authorization of 12 months may be granted for on-demand treatment and control of bleeding episodes.
• Authorization of 1 month may be granted for perioperative management of bleeding in members with mild, moderate, or severe hereditary Factor X deficiency.

Continuation of Therapy

Perioperative management of bleeding

All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

All other indications

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. Coagadex [package insert]. Durham, NC: Bio Products Laboratory USA, Inc.; April 2023.
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 15, 2024.
3. Mumford AD, Ackroyd S, Alikhan R, et al. Guideline for the diagnosis and management of the rare coagulation disorders: a United Kingdom Haemophilia Centre Doctors' Organization guideline on behalf of the British Committee for Standards in Haematology. Br J Haematol. 2014;167(3):304-26.
4. Brown DL, Kouides PA. Diagnosis and treatment of inherited factor X deficiency. 2008;14(6):1176-82.

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