Subject: Specialty Quantity Limit Galafold 2651-H P2022
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 all FDA-approved indications 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
|
|
Galafold (migalastat)
123 mg capsules
|
14 per 28 days
|
123 mg orally once every other day at the
same time of day
|
Place of Service:
Outpatient
The above policy is based on the following references:
- Galafold [package insert]. Philadelphia, PA: Amicus Therapeutics US, LLC; December 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.
August 24, 2022
