Idursulfase (Elaprase)

Idursulfase (Elaprase) is covered only for the FDA‑approved indication of mucopolysaccharidosis type II (Hunter syndrome); uses for other indications are not supported. Coverage requires confirmation by deficient iduronate‑2‑sulfatase activity (leukocytes, fibroblasts, serum/plasma) or molecular genetic testing, prescription by or consultation with a geneticist/endocrinologist/metabolic disorder or lysosomal storage disorder specialist, dosing ≤0.5 mg/kg IV no more than once weekly, and authorization is limited to 12 months.

"Treatment of individuals with mucopolysaccharidosis type II (MPS II; Hunter syndrome) — FDA-approved indication."

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