Galafold — Blue Cross Blue Shield of New Mexico

Initial criteria

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

Reauthorization criteria

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

Approval duration

initial 6 months; renewal 12 months (BCBSIL 12 months)