Naglazyme® (galsulfase)

Naglazyme (galsulfase) is covered only for the FDA‑approved indication—treatment of mucopolysaccharidosis type VI (MPS VI)—and is not covered for other uses. Approval requires confirmatory testing (deficient ARSB enzyme activity in leukocytes/fibroblasts OR biallelic pathogenic/likely pathogenic ARSB variants), prescription by or consultation with a geneticist, endocrinologist, metabolic disorder or lysosomal storage disorder specialist, is authorized for 12 months, and dosing is limited to 1 mg/kg IV once weekly.

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

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