Ultomiris (ravulizumab-cwvz) subcutaneous — Highmark

Initial criteria

• age ≥ 18 years
• Diagnosis of PNH evidenced by either: PNH mutant clone confirmed by flow cytometry OR glycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficient polymorphonuclear cells (PMNs) confirmed by flow cytometry
• Baseline hemoglobin level < 10.5 g/dL
• One of the following: Elevated lactate dehydrogenase (LDH) ≥ 1.5 × ULN OR history of thromboembolic event (e.g., DVT, PE) OR clinical findings of systemic complications (e.g., fatigue, hemoglobinuria, abdominal pain, dyspnea, dysphagia, erectile dysfunction, history of transfusion due to PNH)
• One of the following treatment transition criteria: (a) Currently on Ultomiris IV and will start Ultomiris SC 8 weeks after last Ultomiris IV maintenance dose OR (b) Currently on Soliris IV, will receive weight-based Ultomiris IV loading dose at next Soliris dose, and start Ultomiris SC 2 weeks later OR (c) Not on Ultomiris or Soliris, will receive weight-based Ultomiris IV loading dose and start Ultomiris SC 2 weeks later
• Prescriber attests Ultomiris not used in combination with another complement inhibitor for PNH (e.g., Soliris, Empaveli)

Reauthorization criteria

• Positive clinical response defined as one of the following: (a) hemoglobin stabilization or increase from baseline OR (b) decrease from baseline in number of transfusions OR (c) decrease in LDH levels or reduction of hemolysis

Approval duration

12 months