Ravulizumab-cwvz (Ultomiris)

Ultomiris is covered only for FDA‑approved uses—PNH (IV or adult SC after IV loading), aHUS excluding Shiga toxin–related HUS, and anti‑AChR antibody–positive generalized myasthenia gravis in adults—and is not covered for seronegative gMG or non‑FDA indications. Coverage requires indication‑specific documentation (PNH: peripheral blood flow cytometry showing GPI‑anchor deficiency on ≥2 lineages; aHUS: exclusion of Shiga toxin E. coli; gMG: anti‑AChR positivity, MGFA II–IV, MG‑ADL ≥5, pyridostigmine use/failed/intolerance, prior immunosuppressive therapy history), prescription/consult with the appropriate specialist, adherence to weight‑based loading/maintenance dosing (and IV loading before SC), specified initial/renewal approval periods, and demonstration of clinical benefit at reauthorization.

"Treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) (intravenous) when diagnosis confirmed by peripheral blood flow cytometry showing absence or deficiency of GPI-anchored proteins..."