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