Subject: Coagadex 1942-A SGM P2021

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 and moderate hereditary Factor X deficiency. 

Limitation of Use:
Perioperative management of bleeding in major surgery in patients with severe hereditary Factor X deficiency has not been studied. 

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 or moderate hereditary Factor
      X deficiency (i.e., baseline Factor X assay level ≥ 1 %). 

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.; September 2018.
2.  National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. Revised August 2020.
     MASAC Document #263. https://www.hemophilia.org/sites/default/files/document/files/263_treatment.pdf. Accessed November 20, 2020.
3.  Mumford AD, Ackroyd D. Alikahn 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. Haemophilia. 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.

May 11, 2021