Eculizumab (Soliris)

Soliris (eculizumab) is covered only for its FDA-approved indications—PNH, aHUS (non–Shiga-toxin E. coli), anti‑AChR antibody positive gMG, and anti‑AQP4 antibody positive NMOSD—and is excluded for non‑FDA indications. Coverage requires indication-specific diagnostic confirmation (e.g., flow cytometry for PNH; antibody testing for gMG/NMOSD), age and prior‑therapy restrictions (most adults ≥18; gMG requires pyridostigmine ± two immunosuppressants trialed; NMOSD requires prior satralizumab/inebilizumab or two specified immunosuppressives and documented relapse history), specialist prescribing/consultation (hematologist for PNH, nephrologist for aHUS, neurologist for gMG/NMOSD), IV route- and dose‑specific regimens, set approval durations (typically 6–12 months), and reauthorization with documented continued clinical benefit.

"The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy."