Agalsidase Beta (Fabrazyme®)

Covered only for the FDA‑approved indication of Fabry disease, with dosing limited to 1 mg/kg IV no more frequently than every 2 weeks and approvals issued for up to 12 months; use for non‑FDA indications is not supported. Approval requires documented diagnostic confirmation (deficient α‑galactosidase A activity in leukocytes or fibroblasts or a pathogenic GLA mutation) and prescription by or consultation with a geneticist, endocrinologist, metabolic disorder specialist, or other physician specializing in lysosomal storage disorders.

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

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