Galsulfase (Naglazyme)

Naglazyme (galsulfase) is covered only for the FDA‑approved treatment of mucopolysaccharidosis type VI (MPS VI) and is not covered for other indications. Coverage requires confirmation by deficient N‑acetylgalactosamine‑4‑sulfatase (arylsulfatase B) activity or pathogenic ARSB gene mutation, prescription by or consultation with a geneticist/endocrinologist/metabolic or lysosomal storage disorder specialist, dosing ≤1 mg/kg IV no more than once weekly, documentation of test results, specialist note and patient weight, and authorization is limited to up to 12 months.

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

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