Galafold (migalastat) — Highmark
Fabry disease with an amenable GLA variant
Initial criteria
- age ≥ 18 years
- Diagnosis of Fabry disease (ICD-10: E75.21) confirmed by biochemical and/or genetic testing
- Presence of an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data interpreted by a clinical genetics professional as causing Fabry disease
- Not receiving concomitant enzyme replacement therapy (ERT) such as Fabrazyme (agalsidase beta)
Reauthorization criteria
- Prescriber attests that the member has experienced positive clinical response to therapy
- Member is not receiving concomitant enzyme replacement therapy (ERT) such as Fabrazyme (agalsidase beta)
Approval duration
12 months