Voydeya — Medical Mutual

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
• The 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 AND
• The patient has been established on eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion or subcutaneous injection) for at least 6 months AND
• The medication is prescribed by or in consultation with a hematologist

Reauthorization 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
• The medication is prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion or subcutaneous injection) AND
• The patient has had a response to Voydeya as evidenced by at least one of the following changes from baseline: Hemoglobin increase of at least 2 g/dL in the absence of transfusions, transfusion avoidance, significant improvement in FACIT-Fatigue scores, or significant reduction in absolute reticulocyte count AND
• The medication is prescribed by or in consultation with a hematologist

Approval duration

initial 3 months, reauth 1 year