Vimizim® (elosulfase alfa)

Vimizim (elosulfase alfa) is covered only for the FDA‑approved treatment of mucopolysaccharidosis type IVA (Morquio A) and not for other indications, with approval for 12 months at the specified dose of 2 mg/kg IV weekly infused over 3.5–4.5 hours. Coverage requires confirmed diagnosis by deficient N‑acetylgalactosamine‑6‑sulfatase enzyme activity or molecular genetic testing showing biallelic pathogenic/likely pathogenic variants, prescription by or in consultation with an appropriate specialist (geneticist, endocrinologist, metabolic disorder or lysosomal storage disorder specialist), and meeting applicable safety criteria.

"Diagnosis is confirmed by one of the following: Laboratory test demonstrating deficient N-acetylgalactosamine-6-sulfatase activity in leukocytes or fibroblasts."

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