Agalsidase Beta (Fabrazyme)

Fabrazyme (agalsidase beta) is covered only for the FDA‑approved indication of Fabry disease (other indications excluded) for up to 12 months at a dose up to 1 mg/kg IV no more frequently than every 2 weeks. Approval requires documentation of deficient α‑galactosidase A activity in leukocytes or fibroblasts OR a pathogenic GLA (α‑galactosidase A) gene mutation, prescription by or consultation with a geneticist, endocrinologist, metabolic disorder or lysosomal storage disorder specialist, and supporting clinical records.

"Fabrazyme (agalsidase beta) is indicated for the treatment of individuals with Fabry disease."

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