Ravulizumab-cwvz (Ultomiris)

Ultomiris (ravulizumab‑cwvz) is covered only for FDA‑approved indications—adult PNH and aHUS to inhibit complement‑mediated TMA—and is excluded for non‑FDA uses and for Shiga‑toxin E. coli–related HUS. Coverage requires diagnostic confirmation (PNH: peripheral blood flow cytometry showing GPI‑anchor deficiency on ≥2 cell lineages and age ≥18), prescribing/consultation by a hematologist (PNH) or nephrologist (aHUS), documentation of weight and IV administration, adherence to weight‑based loading and maintenance dosing schedules, and specified approval periods (PNH: initial 6 months, renewal 12 months with demonstrated clinical benefit; aHUS: 12 months).

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

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