Voydeya (danicopan) — Medica

Initial criteria

• Patient is age ≥ 18 years
• Diagnosis of paroxysmal nocturnal hemoglobinuria confirmed by peripheral blood flow cytometry showing absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages
• Medication prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion)
• According to the prescriber, patient has clinically significant extravascular hemolysis while receiving eculizumab or Ultomiris, as evidenced by objective laboratory findings (e.g., reduction in hemoglobin levels, elevated reticulocyte counts, increased transfusion requirements, or transfusion dependence)
• Medication is prescribed by or in consultation with a hematologist

Reauthorization criteria

• Patient is age ≥ 18 years
• Medication prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion)
• According to the prescriber, patient is continuing to derive benefit from Voydeya, as evidenced by increase or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis, or improvement in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
• Medication is prescribed by or in consultation with a hematologist

Approval duration

Initial: 3 months; Reauthorization: 1 year