Elfabrio™ (pegunigalsidase alfa intravenous infusion)

Elfabrio (pegunigalsidase alfa) IV is covered only for the FDA‑approved treatment of adults (≥18 years) with confirmed Fabry disease and is not covered for non‑FDA‑approved uses. Coverage requires laboratory evidence of deficient α‑galactosidase A activity or a pathogenic GLA mutation, prescription by or consultation with a geneticist, endocrinologist, metabolic disorder/lysosomal storage disorder specialist, proof of age, and is authorized for up to 12 months at the recommended dose of 1 mg/kg IV every 2 weeks.

"Elfabrio is indicated for the treatment of adults with confirmed Fabry disease."

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