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danicopan — Blue Cross Blue Shield of Illinois

paroxysmal nocturnal hemoglobinuria (PNH)

Initial criteria

  • ONE of the following:
  • A. The patient has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) AND ALL of the following:
  • 1. Diagnosis 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)
  • 2. The patient has clinically significant extravascular hemolysis (EVH) as indicated by BOTH:
  • A. Hemoglobin ≤ 9.5 g/dL (lab test required)
  • B. Absolute reticulocyte count ≥ 120 x 10^9/L with or without transfusion support (lab test required)
  • 3. BOTH of the following:
  • A. Patient has been treated on a stable dose of Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz) for at least previous 6 months
  • B. Requested agent will be used as add-on therapy to Soliris or Ultomiris
  • OR
  • B. Patient has another FDA labeled indication for the requested agent and route of administration
  • AND
  • If patient has an FDA labeled indication, then ONE of the following:
  • A. The patient’s age is within FDA labeling for the requested indication for the requested agent
  • 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) or has consulted with such specialist
  • AND
  • The patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
  • AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • 2. The patient has had clinical benefit with the requested agent
  • 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or has consulted with such specialist
  • 4. The patient will be using the requested agent as add-on therapy to Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz)
  • 5. The patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
  • 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months