Ultomiris — Medical Mutual

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Initial criteria

Patient age ≥ 1 month; AND
PNH diagnosis confirmed by peripheral blood flow cytometry showing absence or deficiency of GPI-anchored proteins on at least two lineages; AND
LDH level ≥ 1.5 × upper limit of normal range; AND
Greater than 50% GPI-AP deficient polymorphonuclear cells (PMNs); AND
Patient is transfusion dependent defined by one of the following: Hemoglobin < 7 g/dL OR patient is experiencing symptoms of anemia; AND
Patient has symptoms of thromboembolic complications (abdominal pain, shortness of breath, chest pain, end organ damage); AND
Patient will or has received meningococcal vaccine at least 2 weeks before treatment; AND
Prescribed by or in consultation with a hematologist, oncologist, or immunology specialist; AND
Patient is not currently taking another complement inhibitor (pegcetacoplan, eculizumab, iptacopan); AND
Site of care medical necessity is met

Patient has experienced an improvement in fatigue and quality of life; AND
Patient has demonstrated a positive clinical response (stabilization of hemoglobin, decreased transfusion requirements, or transfusion independence, reductions in hemolysis); AND
Patient is not currently taking another complement inhibitor (pegcetacoplan, eculizumab, iptacopan); AND
Site of care medical necessity is met

initial 6 months; reauth 12 months