Subject: Coagadex 1942-A SGM P2024

Drug

COAGADEX  (coagulation Factor X [human])

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 Indications
          Coagadex is indicated in adults and children with hereditary Factor X deficiency for:
          A.  Routine prophylaxis to reduce the frequency of bleeding episodes.
          B.  On-demand treatment and control of bleeding episodes.
          C.  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.


    II.  CRITERIA FOR INITIAL APPROVAL

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


    III.  CONTINUATION OF THERAPY

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

          B.  All other indications
               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. 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 August 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