Empaveli — Cigna
Paroxysmal Nocturnal Hemoglobinuria
Initial criteria
- Patient age ≥ 18 years; AND
 - Diagnosis confirmed by peripheral blood flow cytometry showing absence or deficiency of glycosylphosphatidylinositol-anchored proteins on at least two cell lineages; AND
 - For a patient transitioning to Empaveli from eculizumab intravenous infusion (Soliris, biosimilar), prescriber attests that eculizumab will be discontinued 4 weeks after starting Empaveli; AND
 - Medication is prescribed by or in consultation with a hematologist
 
Reauthorization criteria
- Patient age ≥ 18 years; AND
 - According to the prescriber, patient is continuing to derive benefit from Empaveli (e.g., increased or stabilized hemoglobin levels, decreased transfusion needs, reductions in hemolysis, improvement in FACIT-Fatigue score); AND
 - Medication is prescribed by or in consultation with a hematologist
 
Approval duration
6 months initial, 1 year reauth