Elfabrio (pegunigalsidase)

Elfabrio (pegunigalsidase alfa) is covered for up to 12 months for adults (≥18 years) with confirmed Fabry disease and is not authorized for pediatric patients or for adults lacking the required diagnostic confirmation. Coverage requires documentation of deficient α‑galactosidase A activity OR a pathogenic GLA gene mutation, prescription by or documented consultation with a geneticist, endocrinologist, metabolic disorder or lysosomal storage disorder specialist, and adherence to the recommended dosing of 1 mg/kg IV every 2 weeks (plus age, lab/genetic, prescriber/consultation, and weight documentation).

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

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