Elfabrio™ (pegunigalsidase alfa)

Elfabrio is covered only for adults (≥18) with confirmed Fabry disease (patients <18 excluded) and approval (limited to 12 months) requires ALL of: confirmatory testing (deficient α‑galactosidase A in leukocytes/fibroblasts OR pathogenic GLA variant), prescription by or consultation with a geneticist/endocrinologist/metabolic disorder or lysosomal storage disorder specialist, documentation of actual body weight to support the recommended dosing (1 mg/kg IV every 2 weeks), and clinical records showing the patient meets the policy’s specific coverage/safety criteria.

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

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