Subject: Fingolimod Products SGM 1842-A P2025

Drug

GILENYA  (fingolimod hydrochloride)

TASCENSO ODT  (fingolimod lauryl sulfate)

Policy:

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^1-3

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.

Prescriber Specialties

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

Coverage Criteria

Relapsing Forms of Multiple Sclerosis^1-4

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).

Clinically Isolated Syndrome^1-4

Authorization of 12 months may be granted to members for treatment of clinically isolated syndrome of multiple sclerosis.

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.

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]. Dongguan, China. Sunshine Lake Pharma Co., Ltd.; October 2024.
3. Tascenso ODT [package insert]. Swindon, UK. Catalent Pharma Solutions (UK).; January 2025.
4. Rae-Grant A, Day G, Marrie R, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17)777-788.

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 12, 2025