Subject: Specialty Quantity Limit miglustat-Zavesca 1694-H P2023

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]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; August 2022.
2. miglustat [package insert]. Titusville, NJ: CoTherix, Inc.; July 2022.
3. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; Updated November 7, 2022. https://online.lexi.com. Accessed December 2, 2022.

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 18, 2023