Subject: Specialty Quantity Limit Ruzurgi 3085-H P2021

Drug

RUZURGI  (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
Ruzurgi 10 mg tablet	300 tablets per 30 days	For pediatric patients weighing 45 kg or more: Initial dose of 15 to 30 mg in divided doses. The maximum single dose is 30 mg. The maximum daily maintenance dosage is 100 mg. For 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 divided doses. For pediatric patients weighing less than 45 kg: Initial dose of 7.5 mg to 15 mg in divided doses. The maximum single dose is 15 mg. The maximum daily maintenance dosage is 50 mg. For 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 7.5 mg daily, taken in divided doses.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ruzurgi [package insert]. Princeton, NJ: Jacobus Pharmaceutical Co. Inc.; April 2020.

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