Galafold — CareFirst (Caremark)
Fabry disease with an amenable galactosidase alpha (GLA) gene variant
Initial criteria
- Member is age ≥ 18 years
- Member has an amenable galactosidase alpha (GLA) variant based on in vitro assay data
- Requested medication will not be used in combination with enzyme replacement therapy (ERT) for the treatment of Fabry disease
- Medication is prescribed by or in consultation with a physician who specializes in the treatment of metabolic disease and/or lysosomal storage disorders
Reauthorization criteria
- Member is responding to therapy (e.g., reduction in plasma globotriaosylceramide [GL-3, Gb3] or GL-3/Gb3 inclusions, improvement and/or stabilization in renal function, or pain reduction)
Approval duration
12 months