Ultomiris — Medical Mutual
Atypical Hemolytic Uremic Syndrome (aHUS)
Initial criteria
- Patient age ≥ 1 month; AND
- Patient does not have Shiga toxin E. coli related hemolytic uremic syndrome; AND
- LDH level ≥ 2 × upper limit of normal range; AND
- Patient is transfusion dependent defined by one of the following: Hemoglobin < 7 g/dL OR patient is transfusion dependent; AND
- Patient has symptoms of thromboembolic complications (abdominal pain, shortness of breath, chest pain, end organ damage); AND
- Prescribed by or in consultation with a nephrologist; AND
- Patient will or has received meningococcal vaccine at least 2 weeks before treatment; AND
- Site of care medical necessity is met
Reauthorization criteria
- 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, reductions in hemolysis); AND
- Site of care medical necessity is met
Approval duration
initial 6 months; reauth 12 months