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Voydeya (danicopan)United Healthcare

paroxysmal nocturnal hemoglobinuria (PNH)

Initial criteria

  • Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
  • AND Patient is currently receiving complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
  • AND Patient is experiencing extravascular hemolysis (EVH) while on complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
  • AND Patient will continue to receive complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
  • AND Patient is not receiving Voydeya in combination with a complement protein C3 inhibitor [e.g., Empaveli (Pegcetacoplan)] or a complement factor B inhibitor [e.g., Fabhalta (iptacopan)] used for the treatment of PNH

Reauthorization criteria

  • Documentation of positive clinical response to Voydeya therapy [e.g., decrease in extravascular hemolysis (EVH), increased or stabilization of hemoglobin levels, reduction in transfusions, improvement in hemolysis, etc.]
  • AND Patient continues to receive Voydeya in combination with complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab) for PNH
  • AND Patient is not receiving Voydeya in combination with a complement protein C3 inhibitor [e.g., Empaveli (Pegcetacoplan)] or a complement factor B inhibitor [e.g., Fabhalta (iptacopan)] used for the treatment of PNH

Approval duration

12 months