danicopan — Blue Cross Blue Shield of New Mexico

Initial criteria

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

3 months initial; 12 months renewal