Laronidase (Aldurazyme®)

Aldurazyme (laronidase) is covered only for FDA‑approved MPS I indications — Hurler, Hurler‑Scheie, and Scheie with moderate‑to‑severe symptoms — and other uses are excluded. Approval requires confirmed deficient α‑L‑iduronidase activity (leukocytes, fibroblasts, plasma, or serum) or pathogenic IDUA gene mutation, prescription by or consultation with a geneticist/endocrinologist/metabolic/lysosomal disorder specialist, documentation of the FDA‑approved indication, is authorized for up to 12 months, and follows the recommended 0.58 mg/kg IV weekly dosing.

"Treatment of individuals with the Hurler form of mucopolysaccharidosis type I (MPS I)."

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