migalastat hcl — Blue Cross Blue Shield of Oklahoma

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 AND (B) The patient has a confirmed amenable GLA variant based on in vitro assay data
• 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 the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• 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 the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• 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

6–12 months