Galafold (migalastat) — United Healthcare

Initial criteria

• Diagnosis of Fabry disease
• Patient has an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data
• Patient is not receiving Galafold in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)

Reauthorization criteria

• Documentation of positive clinical response to Galafold therapy
• Patient is not receiving Galafold in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)

Approval duration

12 months