Eculizumab and Associated Biosimilar(s)

This policy covers eculizumab (Soliris®) and its biosimilars for specified indications—including reduction of hemolysis in paroxysmal nocturnal hemoglobinuria (with flow cytometry confirmation), atypical hemolytic uremic syndrome, generalized myasthenia gravis (AChR‑positive, age ≥6, MGFA II–IV, MG‑ADL ≥6) and anti‑AQP4 positive neuromyelitis optica spectrum disorder (age ≥18)—when the listed clinical criteria are met. Coverage requires dosing consistent with authoritative sources or accepted compendia (or two peer‑reviewed articles for off‑label uses), fulfillment of gMG prior‑therapy requirements (≥2 immunosuppressants for ≥1 year or ≥1 plus chronic plasmapheresis/IVIg), appropriate meningococcal vaccination (or risk‑benefit justification), and excludes use in patients who do not meet age/diagnostic criteria or for unproven/contraindicated indications.

"Requested therapy must be proven effective for the relevant diagnosis or procedure."