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Fabhalta (iptacopan) — Blue Cross Blue Shield of Kansas

complement 3 glomerulopathy (C3G)

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • ONE of the following:
  • A. Diagnosis of primary immunoglobulin A nephropathy (IgAN) AND improvement or stabilization with the requested agent as indicated by ONE of the following:
  • 1. Decrease from baseline of urine protein-to-creatinine (UPCR) ratio OR
  • 2. Decrease from baseline in proteinuria OR
  • B. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) AND improvement or stabilization with the requested agent (e.g., decreased requirement of RBC transfusions, stabilization/improvement of hemoglobin, reduction of lactate dehydrogenase (LDH), stabilization/improvement of symptoms) (medical records required) OR
  • C. Diagnosis of complement 3 glomerulopathy (C3G) AND BOTH of the following:
  • 1. Improvement or stabilization with the requested agent as indicated by ONE of the following:
  • A. Decrease from baseline of urine protein-to-creatinine (UPCR) ratio OR
  • B. Decrease from baseline in proteinuria AND
  • 2. ONE of the following:
  • A. BOTH of the following:
  • 1. Currently treated with a maximally tolerated ACE inhibitor, ARB, or combination medication containing an ACEi or ARB within the past 90 days AND
  • 2. Will continue maximally tolerated ACEi, ARB, or combination medication containing an ACEi or ARB therapy in combination with the requested agent OR
  • B. Has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL ACEi, ARB, and combination medications containing an ACEi or ARB OR
  • D. Diagnosis other than IgAN, PNH, or C3G AND has had clinical benefit with the requested agent AND
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, nephrologist), or has consulted with such a specialist AND
  • The patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz) AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months