Subject: Mavenclad SGM 2975-A P2025

Drug

MAVENCLAD  (cladribine)

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 Indications¹

Treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternative drug indicated for the treatment of MS.

Limitations of Use

Mavenclad is not recommended for use in patients with clinically isolated syndrome because of its safety profile.

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 (MS)¹

Initial Request (First Treatment Course)

Authorization of 45 days may be granted for treatment of relapsing forms of multiple sclerosis (including relapsing-remitting and secondary progressive disease for those who continue to experience relapses) and when all of the following criteria are met:

• Inadequate response or unable to tolerate an alternative drug indicated for the treatment of multiple sclerosis.
• Member does not have clinically isolated syndrome.
• Member has not received 2 courses (i.e., 4 cycles) of Mavenclad.

Subsequent Requests (Second Treatment Course)

Authorization of 45 days may be granted for treatment of relapsing forms of multiple sclerosis (including relapsing-remitting and secondary progressive disease for those who continue to experience relapses) and when all of the following criteria are met:

• Member has not received 2 courses (i.e., 4 cycles) of Mavenclad.
• The member has not received Mavenclad in the last 43 weeks.

Other Criteria

• Members will not use Mavenclad concomitantly with other disease modifying multiple sclerosis agents (Note: Ampyra and Nuedexta are not disease modifying).
• 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. Mavenclad [package insert]. Rockland, MA: EMD Serono, Inc.; May 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.

February 15, 2026