Subject: Specialty Quantity Limit miglustat-Zavesca 1694-H P2022

Drug

ZAVESCA  (miglustat)

Policy:

       I.  PROGRAM DESCRIPTION

            The standard limit is designed to allow a quantity
            sufficient for the most common uses of the
            medication. If the member’s plan allows a quantity
            limit exception review for the requested medication,
            coverage of an additional quantity may be provided
            up to the exception limit with prior authorization.

 

     II.  COVERED QUANTITIES  

Medication*	Standard Limit	Exception Limit**	FDA-recommended dosing
Zavesca(miglustat)  100 mg capsules	90 capsules   per 30 days	180 capsules   per 30 days	100 mg orally three times    a day      Dose reductions:    •    Adverse reactions (e.g.,          tremor or diarrhea):         100 mg once or twice a day    •    Mild renal impairment:         100 mg twice per day    •    Moderate renal impairment:         100 mg once per day

*The limit may apply to the generic equivalent medications.
**Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zavesca [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; January 2021.
2. miglustat [package insert]. Horsham, PA: Patriot Pharmaceuticals, LLC.; January 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.

June 26, 2022