migalastat hcl — Blue Cross Blue Shield of Texas

Initial criteria

• The patient has a diagnosis of Fabry disease AND BOTH of the following:
• A. The diagnosis was confirmed by mutation in the galactosidase alpha (GLA) gene
• B. The patient has a confirmed amenable GLA variant based on in vitro assay data (a complete list of amenable variants is available in the Galafold prescribing information, or at http://www.galafoldamenabilitytable.com/hcp)
• If the patient has an FDA labeled indication, then ONE of the following:
• A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
• B. There is support for using the requested agent for the patient’s age for the requested indication
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, nephrologist), or has consulted with such a specialist
• The patient will NOT be using the requested agent in combination with enzyme replacement therapy (ERT) (e.g., Elfabrio, Fabrazyme) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has had clinical benefit with the requested agent
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, nephrologist), or has consulted with a specialist
• The patient will NOT be using the requested agent in combination with enzyme replacement therapy (ERT) (e.g., Elfabrio, Fabrazyme) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

Initial: 6 or 12 months (BCBSIL: 12 months; others: 6 months); Renewal: 12 months