Subject: Kcentra 3001-A Supplemental Specialty PA P2023

Drug

KCENTRA  (prothrombin complex concentrate [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 Indication
          Kcentra is indicated in adult patients for the urgent reversal of
          acquired coagulation factor deficiency induced by Vitamin K
          antagonist (VKA, e.g., warfarin) therapy with acute major
          bleeding or need for an urgent surgery/invasive procedure.

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

 
    II.  CRITERIA FOR INITIAL APPROVAL

          Acquired Coagulation Factor Deficiency
          Authorization of 1 month may be granted for the urgent reversal
          of acquired coagulation factor deficiency induced by vitamin K
          antagonist (VKA, e.g., warfarin) therapy when the member has
          acute major bleeding or is undergoing an urgent surgery or
          invasive procedure.

 
  III.  CONTINUATION OF THERAPY

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

Place of Service:

Outpatient

The above policy is based on the following references:

1. Kcentra [package insert]. Kankakee, IL: CSL Behring LLC; July 2020.

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 15, 2023