Soliris® (eculizumab)

Soliris is covered for its FDA‑approved indications (PNH, aHUS, anti‑AChR antibody–positive gMG, and anti‑AQP4 antibody–positive NMOSD) and excluded for Shiga‑toxin E. coli–related HUS. Coverage requires diagnostic confirmation (PNH by peripheral blood flow cytometry showing GPI‑anchored protein deficiency on ≥2 lineages; positive anti‑AChR or anti‑AQP4 serology), specialist prescribing/consultation (hematologist for PNH, nephrologist for aHUS, neurologist for gMG/NMOSD), specified prior therapy trials or documented failures (e.g., pyridostigmine + two immunosuppressants for gMG; prior Enspryng or Uplizna or two immunosuppressants for NMOSD), IV administration only, documentation of ongoing benefit for renewals, age limits (generally ≥18), and stated approval durations (PNH initial 6 months/renewal 12 months; gMG initial 6 months/renewal 12 months; aHUS 12 months).

"NMOSD: evidence that 'Soliris is prescribed by or in consultation with a neurologist."