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Fabhalta (iptacopan)Highmark

Complement 3 glomerulopathy (C3G)

Initial criteria

  • age ≥ 18 years
  • Diagnosis of complement 3 glomerulopathy (C3G) confirmed by biopsy
  • Experiencing all of the following: urine protein-to-creatinine ratio (UPCR) ≥ 1.0 g/g AND estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
  • Therapeutic failure, contraindication, intolerance, or inadequate response to at least one of the following: systemic corticosteroids OR immunosuppressants OR mycophenolate mofetil
  • Currently receiving the maximally tolerated dose or has experienced intolerance or contraindication to one of the following: ACE inhibitor OR ARB

Reauthorization criteria

  • Member has experienced a reduction in UPCR from baseline

Approval duration

12 months