Subject: dalfampridine-Ampyra 1836-A SGM P2023

Drug

AMPYRA  (dalfampridine)

dalfampridine

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
          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:

1. Ampyra [package insert]. Pearl River, NY: Acorda Therapeutics, Inc.; June 2022.
2. Dalfampridine [package insert]. Somerset, NJ: Micro Labs USA, Inc.; December 2021.
3. Goodman AD, Brown TR, Krupp LB, et al. Sustained-release oral fampridine in multiple sclerosis: a randomized, double-blind, controlled trial.  2009; 373:732-8.

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 14, 2023