Eculizumab (Soliris)

Soliris (eculizumab) is covered only for the FDA‑approved indications—PNH (to reduce hemolysis), aHUS (to inhibit complement‑mediated thrombotic microangiopathy), and adult (≥18) AchR‑antibody–positive generalized myasthenia gravis—and aHUS due to Shiga‑toxin E. coli HUS is excluded. Coverage requires confirmed diagnosis (PNH: flow cytometry on ≥2 lineages; aHUS: exclusion of Shiga‑toxin E. coli HUS; gMG: positive AchR antibody), specialist prescribing/consultation (hematologist/nephrologist for aHUS, hematologist for PNH, neurologist for gMG), adherence to prior‑therapy requirements for gMG (pyridostigmine unless intolerant and trial of two immunosuppressants unless contraindicated), IV dosing per indication, documentation of clinical benefit for reauthorization, age limits (PNH/gMG ≥18), and specified approval durations (initial: PNH/gMG 6 months, aHUS 12 months; renewals 12 months).

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