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Elfabrio (pegunigalsidase alfa) — Medica

Fabry disease

Initial criteria

  • Patient age ≥ 18 years; AND
  • Diagnosis established by ONE of the following: (i) laboratory test demonstrating deficient α-galactosidase A activity in leukocytes or fibroblasts; OR (ii) molecular genetic test demonstrating a pathogenic variant in the galactosidase alpha (GLA) gene; AND
  • Elfabrio is prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder sub-specialist, or a physician who specializes in the treatment of lysosomal storage disorders; AND
  • NOT used concurrently with Galafold (migalastat) or Fabrazyme (agalsidase beta).

Approval duration

1 year