Galsulfase (Naglazyme®)

Naglazyme (galsulfase) is covered only for the FDA‑approved indication MPS VI when diagnosis is confirmed by deficient arylsulfatase B (N‑acetylgalactosamine 4‑sulfatase) activity or by molecular genetic testing, with approval for up to 12 months and dosing limited to 1 mg/kg IV no more frequently than once weekly. Coverage requires prescription by or consultation with a geneticist, endocrinologist, metabolic disorder subspecialist or lysosomal storage disorder specialist and submission of the specified laboratory/genetic and clinical/safety documentation; other indications or dosing/frequency outside these parameters are not supported.

"Naglazyme (galsulfase) is indicated for the treatment of mucopolysaccharidosis type VI (MPS VI; Maroteaux-Lamy Syndrome)."

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