Fabrazyme® (agalsidase beta)

Fabrazyme (agalsidase beta) is covered only for FDA‑approved treatment of Fabry disease when diagnosis is confirmed by deficient alpha‑galactosidase A activity or a pathogenic GLA (galactosidase alpha) mutation; dosing is 1 mg/kg IV every two weeks and approval is for 12 months. Coverage requires prescription by or consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or lysosomal storage disorder specialist and submission of diagnostic test results and medical records proving the patient meets the policy criteria (off‑label uses are not covered).

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

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