Voydeya — Blue Cross Blue Shield of Kansas

Initial criteria

• Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) confirmed by flow cytometry with at least 2 independent reagents on at least 2 cell lineages demonstrating deficiency in glycosylphosphatidylinositol (GPI)-linked proteins (lab tests required)
• Patient has clinically significant extravascular hemolysis (EVH) as indicated by BOTH of the following: Hemoglobin ≤ 9.5 g/dL (lab test required) AND Absolute reticulocyte count ≥ 120 × 10^9/L (lab test 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
• Voydeya will be used as add-on therapy to Soliris, Bkemv, Epysqli, or Ultomiris
• OR patient has another FDA labeled indication for Voydeya and route of administration
• If patient has an FDA labeled indication, ONE of the following: (A) age is within FDA labeling for requested indication OR (B) there is support for use at that age
• Prescriber is a specialist in hematology or has consulted with a specialist
• Patient will NOT be using Voydeya in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
• Patient does NOT have any FDA labeled contraindications to Voydeya

Reauthorization criteria

• Patient was previously approved for Voydeya through the plan’s prior authorization process
• Patient has had clinical benefit with Voydeya
• Prescriber is a specialist in hematology or has consulted with a specialist
• Voydeya will be used as add-on therapy to Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), or Ultomiris (ravulizumab-cwvz)
• Voydeya will NOT be used in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
• Patient does NOT have any FDA labeled contraindications to Voydeya

Approval duration

initial 3 months; renewal 12 months