Subject: Vumerity 3395-A SGM P2022

Drug

VUMERITY  (diroximel 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 Indications
          Vumerity 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 (MS)
                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
           to members who are experiencing disease stability or
           improvement while receiving Vumerity. 

 
      V.  OTHER CRITERIA

           A.  Members will not use Vumerity concomitantly with
                other disease modifying multiple sclerosis agents
                (Note: Ampyra and Nuedexta are not disease modifying).
           B.  Authorization may be granted for pediatric members less
                than 18 years of age when benefits outweigh risks.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Vumerity [package insert]. Cambridge, MA: Biogen; February 2022.

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.

March 28, 2023