Subject: Kesimpta 4129-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
Kesimpta 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
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
for members who are experiencing disease stability or
improvement while receiving Kesimpta.
V. OTHER CRITERIA
A. Members will not use Kesimpta 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:
- Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 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.
February 11, 2024
