Voydeya (danicopan) — United Healthcare

Initial criteria

• Submission of medical records (e.g., chart notes, laboratory values, etc.) documenting the diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) as confirmed by BOTH of the following: (1) Flow cytometry analysis confirming presence of PNH clones AND (2) Laboratory results, signs, and/or symptoms attributed to PNH (e.g., abdominal pain, anemia, dyspnea, extreme fatigue, smooth muscle dystonia, unexplained/unusual thrombosis, hemolysis/hemoglobinuria, kidney disease, pulmonary hypertension, etc.)
• Patient is currently receiving complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
• Patient is experiencing extravascular hemolysis (EVH) while on complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
• Patient will continue to receive complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
• 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
• Prescribed by, or in consultation with, a hematologist OR oncologist

Reauthorization criteria

• Documentation of positive clinical response to Voydeya therapy (e.g., decrease in extravascular hemolysis, increased or stabilization of hemoglobin levels, reduction in transfusions, improvement in hemolysis, etc.)
• Patient continues to receive Voydeya in combination with complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab) for PNH
• 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
• Prescribed by, or in consultation with, a hematologist OR oncologist

Approval duration

12 months