Subject: dalfampridine-Ampyra 1836-A SGM P2021
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
Ampyra is indicated as a treatment to improve walking in adult patients with multiple
sclerosis. This was demonstrated by an increase in walking speed.
All other indications are considered experimental/investigational and are not medically
necessary.
II. CRITERIA FOR INITIAL APPROVAL
Authorization of 30 days may be granted to members with a diagnosis of multiple sclerosis if
the member has sustained walking impairment (prior to initiating therapy with Ampyra).
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted to members with multiple sclerosis if the
member has experienced an improvement in walking speed or other objective measure of
walking ability since starting Ampyra.
Place of Service:
Outpatient
The above policy is based on the following references:
IV. REFERENCES
- Ampyra [package insert]. Ardsley, NY: Acorda Therapeutics, Inc.; February 2021.
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.
September 28, 2021
