Ravulizumab-cwvz (Ultomiris)

Ultomiris (ravulizumab‑cwvz) is covered for FDA‑approved PNH and aHUS (explicitly excluding Shiga toxin E. coli–related HUS) when prescribed/consulted by the appropriate specialist (hematologist for PNH, nephrologist for aHUS) and administered IV per weight‑based loading and maintenance dosing. Coverage requires PNH confirmation by peripheral blood flow cytometry showing GPI‑anchored protein deficiency on ≥2 cell lineages, documentation of weight and infusion records, initial PNH approval 6 months (renewal 12 months) and aHUS approval 12 months, and PNH reauthorization must demonstrate continued clinical benefit (e.g., stabilized hemoglobin, reduced transfusions or hemolysis).

"The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH)."

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