Pegunigalsidase Alfa-iwxj (Elfabrio®)

By November 1, 2026: Billing and clinical teams must implement prior authorization workflows for Elfabrio (pegunigalsidase alfa-iwxj) claims. (1) Update billing system to require prior auth before claim submission for this medication. (2) Create prior auth submission checklist requiring: initial requests must include alpha-galactosidase enzyme assay results or genetic testing AND documented baseline clinical signs/symptoms (acroparesthesias, angiokeratomas, GI symptoms, corneal opacities); continuation requests must include chart notes documenting therapeutic response (GL-3/Gb3 reduction, renal function improvement, or pain reduction). (3) Implement system validation to confirm prescriber specialty is metabolic disease and/or lysosomal storage disorder specialist. (4) Add drug interaction check to flag if patient is concurrently on Galafold or Fabrazyme (coverage will be denied). (5) Train providers and prior auth team on 18+ age requirement and symptomatic obligate carrier qualification. Failure to obtain proper prior authorization will result in claim denials. Update prior auth templates and communication tools by effective date.