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Voydeya™

DrugVoydeya™ (danicopan) [Alexion Pharmaceuticals Inc.]

January 2025

Therapeutic area - PNH Agents

Initial approval criteria:

  • Patient age ≥ 18 years; AND
  • Patient has diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) confirmed by flow cytometry diagnostic testing revealing:
    • detection of PNH clones of ≥ 10%; AND
    • the presence of ≥ 2 different glycosylphosphatidylinositol (GPI) protein deficiencies (e.g., CD55, CD59) within ≥ 2 different cell lines (e.g., granulocytes, monocytes, erythrocytes); AND
  • Patient has clinically evident extravascular hemolysis (EVH) defined by anemia (hemoglobin [Hb] ≤ 9.5 g/dL with absolute reticulocyte count ≥ 120 x 109/L with or without transfusion support; AND
  • Patient has baseline platelet count ≥ 30,000/ µL AND
  • Patient has absolute neutrophil counts (ANC) ≥ 500 µL; AND
  • Patient has received a stable dose of C5 inhibitor therapy (ravulizumab-cwvz [Ultomiris®] or eculizumab [Soliris®]) for ≥6 months prior to starting danicopan; AND
  • Danicopan will be used as add-on therapy to eculizumab (Soliris) or ravulizumab-xwvz (Ultomiris); AND
  • Danicopan will NOT be used in combination with pegcetacoplan (Empaveli®) or iptacopan (Fabhalta®); AND
  • Patient does NOT have any of the following:
    • severe hepatic impairment (Child-Pugh Class C); AND
    • unresolved serious infection caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type B; AND
  • Patient has documented vaccinations for N. meningitidis and S. pneumoniae ≥ 2 weeks prior to initiating danicopan therapy; AND
  • Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  • Prescriber is enrolled in the Voydeya Risk Evaluation and Mitigation Strategy (REMS) program
  • Initial approval is for 3 months

Renewal criteria:

  • Patient must continue to meet the above criteria; AND
  • Patient has demonstrated improvement or stabilization of PNH from baseline (e.g., decreased requirement of red blood cell [RBC] transfusions, Hb stabilization or improvement, lactate dehydrogenase [LDH] reduction, symptom improvement or stabilization, reduction in thrombotic events); AND
  • Patient does NOT have treatment restricting adverse effects (e.g., encapsulated bacterial infection, clinically significant or symptomatic hepatic enzyme elevations)
  • Renewal approval is for 12 months

Quantity limits

  • 50 mg tablet: 270 tablets/30 days
  • 100 mg tablet: 180 tablets/30 days
  • (Recommended daily dose: 150 mg three times daily; maximum: 200 mg three times daily)

Background

Voydeya is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Voydeya has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.

Questions?

Provider Call Center (844) 575-7887

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