Empaveli — Medica

Initial criteria

• Patient is ≥ 18 years of age
• Paroxysmal nocturnal hemoglobinuria diagnosis was confirmed by peripheral blood flow cytometry results showing absence or deficiency of glycosylphosphatidylinositol-anchored proteins on at least two cell lineages
• For a patient transitioning to Empaveli from eculizumab intravenous infusion (Soliris, biosimilar), the prescriber attests that eculizumab will be discontinued 4 weeks after starting Empaveli
• The medication is prescribed by or in consultation with a hematologist

Reauthorization criteria

• Patient is ≥ 18 years of age
• According to the prescriber, patient is continuing to derive benefit from Empaveli (examples include increase in or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in Functional Assessment of Chronic Illness Therapy-Fatigue score)
• The medication is prescribed by or in consultation with a hematologist

Approval duration

initial 6 months, renewal 1 year