Lumizyme® (alglucosidase alfa)

Covered: Lumizyme (alglucosidase alfa) is covered only for the FDA‑approved indication of Pompe disease (acid α‑glucosidase deficiency) and not for non‑FDA uses. Key requirements: diagnosis must be confirmed by deficient acid α‑glucosidase enzyme assay (blood, fibroblasts, or muscle) or molecular testing showing biallelic pathogenic/likely‑pathogenic GAA variants, it must be prescribed by or in consultation with a geneticist, neurologist, metabolic disorder subspecialist, or lysosomal storage disorder specialist, dosed 20 mg/kg IV every 2 weeks, with approval granted for up to 12 months and documentation of tests and specialist involvement.

"Lumizyme (alglucosidase alfa) is indicated for the treatment of individuals with Pompe disease (acid α-glucosidase deficiency)."

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