Eculizumab (Soliris)

Soliris is covered only for its FDA‑approved indications — paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome (pediatric dosing allowed only for aHUS) and anti‑AChR antibody‑positive generalized myasthenia gravis — with off‑label uses and Shiga toxin E. coli‑related HUS excluded. Approval requires resolution of any serious Neisseria meningitidis infection, meningococcal vaccination ≥2 weeks prior (or documented rationale to start earlier), indication‑specific confirmation (PNH by flow cytometry; aHUS with exclusion of Shiga toxin E. coli; gMG anti‑AChR positive, MGFA II–IV and prior therapy failure — ≥1 year with ≥2 immunosuppressants or 1 immunosuppressant plus plasmapheresis/IVIG), adherence to IV dosing timing, 12‑month authorizations, reauthorization for gMG showing clinical benefit, and pediatric weight documentation for aHUS dosing.

"Paroxysmal nocturnal hemoglobinuria to reduce hemolysis (FDA-approved indication)."