Subject: Specialty Quantity Limit Firdapse 2828-H P2021

Drug

FIRDAPSE  (amifampridine)

Policy:

I.     PROGRAM DESCRIPTION
       The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended
       dosing parameters for Lambert-Eaton myasthenic syndrome (LEMS) fall within the standard limits. Coverage of an additional
       quantity may be reviewed on a case-by-case basis upon request.


II.    COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Firdapse 10 mg tablets	240 tablets per 30 days	Recommended starting dose is 15 mg to 30 mg daily in divided doses (3 to 4 times daily). The dosage can be increased by 5 mg daily every 3 to 4 days. The maximum single dose is 20mg. The maximum daily maintenance dosage is 80 mg. Recommended starting dose in patients with renal impairment (creatinine clearance 15 to 90 mL/min), any degree of hepatic impairment, and who are known N-acetyltransferase 2 (NAT2) poor metabolizers is 15 mg daily, taken in 3 divided doses.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Firdapse [package insert]. Coral Gables, FL: Catalyst Pharmaceuticals, 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.

December 14, 2021