Galsulfase (Naglazyme®)

Galsulfase (Naglazyme) is covered only for mucopolysaccharidosis type VI (MPS VI) and is excluded for other indications or when the required diagnostic confirmation or specialist involvement is absent. Coverage requires confirmed ARSB deficiency by enzyme assay in leukocytes/fibroblasts or a pathogenic ARSB gene mutation, prescription by or consultation with a geneticist/endocrinologist/metabolic-disorder or lysosomal-storage-disease specialist, documentation of diagnosis/safety/prior treatment, dosing ≤1 mg/kg IV no more than weekly, and approval is limited to 12 months.

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

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