Naglazyme® (galsulfase)

Naglazyme is covered only for the FDA‑approved indication of mucopolysaccharidosis type VI (MPS VI) and is excluded for other uses. Approval (12 months) requires confirmed diagnosis by deficient arylsulfatase B enzyme activity or N‑acetylgalactosamine 4‑sulfatase gene mutation, prescription by or consultation with a geneticist/endocrinologist/metabolic/lysosomal-disorder specialist, dosing at 1 mg/kg IV weekly, documentation of tests, patient weight and infusion records, and adherence to applicable safety criteria.

"Treatment of mucopolysaccharidosis type VI (MPS VI; Maroteaux-Lamy Syndrome)."

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