Voydeya — Blue Cross Blue Shield of Alabama

Initial criteria

• 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)
• Clinically significant extravascular hemolysis (EVH) as indicated by BOTH of the following: Hemoglobin ≤ 9.5 g/dL (lab tests required) AND Absolute reticulocyte count ≥ 120 × 10^9/L with or without transfusion support (lab tests required)
• Patient has been treated on a stable dose of Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), or Ultomiris (ravulizumab-cwvz) for at least the previous 6 months
• Requested agent will be used as add-on therapy to Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), or Ultomiris (ravulizumab-cwvz)
• OR patient has another FDA labeled indication for the requested agent and route of administration
• If the patient has an FDA labeled indication, then ONE of the following: patient’s age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient’s age for the requested indication
• 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
• Patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• 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
• Patient will be using the requested agent as add-on therapy to Soliris (eculizumab), Bkemv (eculizumab-aeeb), Ep=mysqli(aagh), or Ultomiris (ravulizumab-cwvz)
• Patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 3 months; renewal 12 months