Agalsidase Beta (Fabrazyme®)

Fabrazyme (agalsidase beta) is covered only for the FDA‑approved indication of Fabry disease and other indications are excluded. Coverage requires documented deficient α‑galactosidase A activity in leukocytes or fibroblasts or a pathogenic GLA gene mutation, prescription by or consultation with a geneticist/endocrinologist/metabolic disorder or lysosomal storage disorder specialist, adherence to the recommended dosing (1 mg/kg IV every 2 weeks), documentation of test results/diagnosis, and is approved for a 12‑month duration.

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

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