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Fabhalta (iptacopan) — Blue Cross Blue Shield of New Mexico

Other FDA-labeled indication

Initial criteria

  • ONE of the following:
  • A. Diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages (e.g., RBCs and WBCs) demonstrating deficiency in glycosylphosphatidylinositol (GPI)-linked proteins (lab tests required) OR
  • B. Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND ALL of the following:
  • 1. Urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g AND
  • 2. eGFR ≥ 30 mL/min/1.73 m^2 AND
  • 3. ONE of the following:
  • A. Tried and had inadequate response after ≥ 3 months of therapy with maximally tolerated ACE inhibitor or ARB, or combination medication containing an ACEI or ARB OR
  • B. Intolerance or hypersensitivity to an ACEI or ARB, or combination medication containing an ACEI or ARB OR
  • C. FDA labeled contraindication to ALL ACEI or ARB agents AND
  • 4. ONE of the following:
  • A. Tried and had inadequate response after 6-month course of glucocorticoid therapy (e.g., methylprednisolone, prednisolone, prednisone) OR
  • B. Intolerance or hypersensitivity to glucocorticoid therapy OR
  • C. FDA labeled contraindication to ALL glucocorticoid therapies OR
  • D. Support that glucocorticoid therapy is NOT appropriate for the patient AND
  • 5. Patient will continue on standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2, aliskiren) OR
  • C. Patient has another FDA labeled indication for the requested agent and route of administration AND
  • If patient has an FDA labeled indication, ONE of the following:
  • A. Age is within FDA labeling for the requested indication OR
  • B. Support for using the requested agent for patient's age for the requested indication AND
  • Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist, nephrologist) OR has consulted with such specialist AND
  • Patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz) AND
  • No FDA labeled contraindications to the requested agent.

Reauthorization criteria

  • Patient previously approved through the plan’s Prior Authorization process AND
  • ONE of the following:
  • A. IgAN: improvements or stabilization with requested agent as indicated by ONE of:
  • 1. Decrease from baseline of urine protein-to-creatinine ratio (UPCR) OR
  • 2. Decrease from baseline in proteinuria AND
  • Continues standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2, aliskiren) OR
  • B. PNH: improvements or stabilization (e.g., decreased RBC transfusions, stabilization/improvement of hemoglobin, reduction of LDH, stabilization/improvement of symptoms) OR
  • C. Other indications: clinical benefit with requested agent AND
  • Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, nephrologist) or has consulted with specialist AND
  • Patient will NOT be using in combination with Empaveli, Soliris, Ultomiris, or Piasky AND
  • No FDA labeled contraindications to the requested agent.

Approval duration

6-12 months (initial) / 12 months (renewal)