Voydeya (danicopan tablets – Alexion) — Cigna
Paroxysmal nocturnal hemoglobinuria (PNH)
Initial criteria
- Patient is age ≥ 18 years; AND
- Paroxysmal nocturnal hemoglobinuria diagnosis was confirmed by peripheral blood flow cytometry results showing the absence or deficiency of glycosylphosphatidylinositol-anchored proteins on at least two cell lineages; AND
- Medication is prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion); AND
- 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, transfusion-dependence); AND
- Medication is prescribed by or in consultation with a hematologist
Reauthorization criteria
- Patient is age ≥ 18 years; AND
- Medication is prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion); AND
- According to the prescriber, patient is continuing to derive benefit from Voydeya (e.g., increase in or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score); AND
- Medication is prescribed by or in consultation with a hematologist
Approval duration
3 months initial, 1 year reauth