Eculizumab (Soliris)

Soliris (eculizumab) is covered only for FDA‑approved indications—PNH, aHUS (excluding Shiga toxin E. coli–related HUS; pediatric aHUS uses weight‑based dosing), anti‑AChR antibody–positive gMG, and anti‑AQP4 antibody–positive NMOSD—with age limits (generally ≥18 years), IV administration, and indication‑specific dosing. Coverage requires diagnostic confirmation, specialty prescriber involvement (hematology/nephrology/neurology), required prior therapy trials (e.g., pyridostigmine + ≥2 immunosuppressants for gMG; Enspryng or Uplinza or two immunosuppressives for NMOSD), documentation excluding STEC‑HUS for aHUS, and demonstration of clinical benefit for reauthorization with defined approval durations.

"Generalized Myasthenia Gravis (gMG) initial approval duration: 6 months; renewal approval duration: 12 months."

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