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Fabhalta (iptacopan) — Blue Cross Blue Shield of Illinois

Other FDA-labeled indications

Initial criteria

  • ONE of the following:
  • A. Diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) as confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages (e.g., RBCs and WBCs) demonstrating that the patient’s peripheral blood cells are deficient 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 an inadequate response after ≥3 months of therapy with a maximally tolerated ACE inhibitor (e.g., benazepril, lisinopril) or angiotensin II receptor blocker (e.g., losartan), or a combination medication containing an ACEI or ARB OR
  •   B. Intolerance or hypersensitivity to an ACEI or ARB or any 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 an inadequate response after a 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. There is support that glucocorticoid therapy is NOT appropriate for the patient AND
  •  5. The patient will continue on standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2 inhibitor, aliskiren) OR
  • C. The patient has another FDA labeled indication for the requested agent and route of administration AND
  • If the patient has an FDA labeled indication, then ONE of the following:
  •  A. The patient’s age is within FDA labeling for the requested indication OR
  •  B. There is support for using the requested agent for the patient’s age for the requested indication AND
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, nephrologist) or has consulted with a specialist AND
  • The patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz) AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent.
  • Additional pathway for Ohio fully insured/HIM Shop (SG) members:
  •  1. Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
  •   A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
  •   B. ONE of the following:
  •    1. The patient has another FDA labeled indication for the requested agent and route of administration OR
  •    2. The patient has another indication supported in compendia for the requested agent and route of administration OR
  •    3. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals supporting the proposed use as generally safe and effective (excluding case studies).

Reauthorization criteria

  • The patient has been previously approved through the plan’s Prior Authorization process AND
  • ONE of the following:
  • A. Diagnosis of IgAN AND BOTH of the following:
  •  1. Improvement or stabilization with the requested agent as indicated by ONE of the following:
  •   A. Decrease from baseline in urine protein-to-creatinine (UPCR) ratio OR
  •   B. Decrease from baseline in proteinuria AND
  •  2. Will continue standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2 inhibitor, aliskiren) OR
  • B. Diagnosis of PNH AND improvement or stabilization with the requested agent (e.g., decreased requirement of RBC transfusions, improvement/stabilization of hemoglobin, reduction of LDH, improvement/stabilization of symptoms) OR
  • C. Diagnosis other than IgAN or PNH AND has had clinical benefit with the requested agent AND
  • Prescriber is a specialist in the area of diagnosis (e.g., hematologist, nephrologist) or has consulted with one AND
  • The patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Soliris (eculizumab), 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