Subject: fingolimod-Gilenya-Tascenso ODT 1842-A SGM P2024

Drug

GILENYA  (fingolimod hydrochloride)

TASCENSO ODT  (fingolimod lauryl sulfate)

fingolimod hydrochloride

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
          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
          patients 10 years of age and older.

          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 treatment of clinically isolated
               syndrome of multiple sclerosis.


   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 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. Gilenya [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2024.
2. Fingolimod [package insert]. Weston, FL: Apotex Corp.; June 2024.
3. Tascenso ODT [package insert]. Swindon, UK: Catalent Pharma Solutions (UK); June 2024.

 

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 30, 2024