Idursulfase (Elaprase®)

Elaprase (idursulfase) is covered only for the FDA‑approved indication of mucopolysaccharidosis type II (MPS II; Hunter syndrome); all other indications are excluded. Coverage requires confirmed diagnosis by deficient iduronate‑2‑sulfatase activity (leukocytes, fibroblasts, serum/plasma) or molecular genetic IDS mutation, prescription by or consultation with an appropriate specialist (geneticist, endocrinologist, metabolic disorder or lysosomal storage disorder specialist), submission of lab/genetic and specialist documentation, dosing ≤0.5 mg/kg IV no more than once weekly, and approvals are limited to 12 months (subject to safety criteria).

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

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