Subject: Coagadex 1942-A SGM P2023a

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. 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 4, 2023.
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.

November 12, 2023