Ultomiris — Medica
Paroxysmal Nocturnal Hemoglobinuria
Initial criteria
- Diagnosis was confirmed by peripheral blood flow cytometry results showing absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages
- The medication is prescribed by or in consultation with a hematologist
Reauthorization criteria
- According to the prescriber, patient is continuing to derive benefit from Ultomiris (examples include 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)
- The medication is prescribed by or in consultation with a hematologist
Approval duration
initial: 6 months; continuation: 1 year