Ultomiris subcutaneous — Medica

Initial criteria

• Patient age ≥ 18 years
• Diagnosis confirmed by peripheral blood flow cytometry showing absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages
• Patient has received or will receive Ultomiris intravenous infusion loading dose prior to initiation of Ultomiris subcutaneous
• Medication is prescribed by or in consultation with a hematologist

Reauthorization criteria

• Patient age ≥ 18 years
• Patient has been established on therapy for at least 6 months
• Patient is continuing to derive benefit from Ultomiris (intravenous or subcutaneous), according to the prescriber (e.g., stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis)
• Medication is prescribed by or in consultation with a hematologist

Approval duration

6 months initial, 1 year reauthorization