Idursulfase (Elaprase®)

Elaprase (idursulfase) is covered only for the FDA‑approved treatment of mucopolysaccharidosis type II (Hunter syndrome); off‑label uses are excluded. Approval requires documented iduronate‑2‑sulfatase deficiency in leukocytes/fibroblasts/serum/plasma or a pathogenic IDS gene mutation, prescription by or in consultation with a geneticist, endocrinologist, metabolic disorder or lysosomal storage disorder specialist, IV dosing of 0.5 mg/kg weekly, documentation of applicable safety criteria, and is authorized for up to 12 months (renewal required).

"Must meet all of the following criteria for approval (i."

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