Subject: dimethyl fumarate-Tecfidera 1845-A SGM P2023

Drug

TECFIDERA  (dimethyl fumarate)

dimethyl fumarate

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
          Tecfidera is indicated for the treatment of relapsing forms of
          multiple sclerosis (MS), to include clinically isolated syndrome,
          relapsing-remitting disease, and active secondary progressive
          disease, in adults.

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


    II.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with a
          neurologist.


  III.  CRITERIA FOR INITIAL APPROVAL

 
          A.  Relapsing forms of multiple sclerosis
               Authorization of 12 months may be granted to members who
               have been diagnosed with a relapsing form of multiple
               sclerosis (including relapsing-remitting and secondary
               progressive disease for those who continue to experience
               relapse).

          B.  Clinically isolated syndrome
               Authorization of 12 months may be granted to members for
               the treatment of clinically isolated syndrome.


   IV.  CONTINUATION OF THERAPY

          For all indications: Authorization of 12 months may be granted
          for members who are experiencing disease stability or
          improvement while receiving the requested medication.


    V.  OTHER

          Members will not use the requested medication concomitantly
          with other disease modifying multiple sclerosis agents (Note:
          Ampyra and Nuedexta are not disease modifying).

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tecfidera [package insert]. Cambridge, MA: Biogen Inc.; February 2023.
2. dimethyl fumarate [package insert]. East Windsor, NJ: Aurobindo Pharma USA, Inc.; February 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.

October 14, 2023