Imiglucerase (Cerezyme)

Cerezyme (imiglucerase) is covered only for the FDA‑approved treatment of Type 1 Gaucher disease and is not authorized for other Gaucher types or non‑FDA indications. Approval (up to 1 year) requires documentation of diagnosis by deficient β‑glucocerebrosidase activity in leukocytes/fibroblasts or by molecular genetic testing, prescription by or consultation with a qualifying specialist (geneticist, endocrinologist, metabolic disorder subspecialist, or lysosomal storage disorder specialist), dosing of 60 U/kg IV no more frequently than every 2 weeks, and satisfaction of referenced safety criteria.

"Treatment of individuals with Type 1 Gaucher disease (FDA-approved indication)."

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