GALAFOLD (migalastat)

GALAFOLD (migalastat)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

• The treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data
• This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Patients must meet the following criteria for the following indication (as confirmed by medical records documentation):

• Diagnosis of Fabry Disease, AND
• The patient is 18 year of age or older; AND
• has an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data; AND
• Galafold is prescribed by or in consultation with a geneticist, nephrologist, or a physician who specializes in the treatment of Fabry disease, AND
• Galafold will not be used with Fabrazyme

Dosing:

• Recommended dose is 123mg orally once every other day (QOD). Take Galafold on an empty stomach, do not consume food at least 2 hours before and 2 hours after taking Galafold.

Approval:

• One year