Agalsidase Beta (Fabrazyme)

Agalsidase beta (Fabrazyme) is covered only for the FDA‑approved treatment of Fabry disease (non‑FDA indications are excluded). Coverage requires documented diagnosis by deficient α‑galactosidase A activity in leukocytes/fibroblasts or a pathogenic GLA mutation, prescription by or consultation with a geneticist/endocrinologist/metabolic- or lysosomal-storage-disorder specialist, dosing up to 1 mg/kg IV every 2 weeks, and is approved for a 12‑month duration with supporting lab/genetic and prescriber documentation.

"Treatment of individuals with Fabry disease (FDA-approved indication)."

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