Galsulfase (Naglazyme)

Covered only for the FDA‑approved indication — treatment of Mucopolysaccharidosis VI (Maroteaux‑Lamy); off‑label uses are not covered. Authorization is for up to 12 months and requires diagnosis confirmed by enzyme assay showing N‑acetylgalactosamine‑4‑sulfatase deficiency or genetic testing, with recommended premedication (antihistamines ± antipyretics), monitoring for anaphylaxis, immune- and infusion-associated reactions, and surveillance for spinal/cervical cord compression (discontinue and treat immediately for severe allergic reactions).

"Sleep apnea is common in MPS VI individuals and antihistamine pretreatment may increase the risk of apneic episodes."

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