Subject: Mavenclad 2975-A SGM P2023
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
Mavenclad is indicated for the 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 (CIS) because of its safety profile.
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
Multiple Sclerosis
A. Initial requests
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:
1. Inadequate response or unable to tolerate an alternative
drug indicated for the treatment of multiple sclerosis.
2. Member does not have clinically isolated syndrome (CIS).
3. Member has not received 2 courses (i.e., 4 cycles) of
Mavenclad.
B. Subsequent requests
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:
1. Member has not received 2 courses (i.e., 4 cycles) of
Mavenclad.
2. The member has not received Mavenclad in the last 43
weeks.
IV. OTHER CRITERIA
A. Members will not use Mavenclad 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:
- Mavenclad [package insert]. Rockland, MA: EMD Serono, Inc.; September 2022.
- Giovannoni, G., Comi, G., Cook, S., et al. A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis. N Engl J Med 2010;362:416-426.
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 11, 2024
