Laronidase (Aldurazyme)

Aldurazyme (laronidase) is covered only for MPS I confirmed by enzyme assay or genetic testing for Hurler or Hurler–Scheie phenotypes, and for Scheie patients only if symptoms are moderate-to-severe; off‑label uses are not supported. Approval (up to 12 months) requires documentation of diagnosis/subtype and symptom severity for Scheie, and safety measures include pretreatment to reduce infusion reactions, considering delay for acute febrile/respiratory illness, and immediate discontinuation/treatment for anaphylaxis.

"No off-label uses meet evidence standards"

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