Eculizumab (CPB 0807, reviewed 2026-08-11)
Summary
Aetna considers eculizumab (Soliris), eculizumab-aeeb (Bkemv) and eculizumab-aagh (Epysqli) medically necessary for commercial medical plans when the criteria for the indication are met. Bkemv and Epysqli are biosimilars to Soliris and carry the same labeled indications except for NMOSD and pediatric gMG. Precertification is required of all Aetna participating providers and members in applicable plan designs. Medicare criteria are listed separately under Medicare Part B Criteria. For atypical hemolytic uremic syndrome (aHUS) not caused by Shiga toxin, the member must have ADAMTS 13 activity above 5%, no Shiga toxin, and the drug will not be used in combination with another complement inhibitor such as Ultomiris. For paroxysmal nocturnal hemoglobinuria (PNH), the diagnosis must be confirmed by flow cytometry showing deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs), the member must have clinical manifestations such as LDH greater than 1.5 times the upper limit of normal, thrombosis, renal dysfunction, pulmonary hypertension or dysphagia, and the drug will not be used with another complement inhibitor (concomitant use with Voydeya is allowed). For generalized myasthenia gravis (gMG), the member must be anti-acetylcholine receptor antibody positive, have MGFA clinical classification II to IV, have an MG-ADL total score of 5 or greater, and have either an inadequate response or intolerable adverse event to at least two immunosuppressive therapies over at least 12 months, an inadequate response or intolerable adverse event to one immunosuppressive therapy plus IVIG over at least 12 months, or a documented clinical reason to avoid immunosuppressive agents and IVIG. The drug will not be used with another complement inhibitor, a neonatal Fc receptor blocker, or Uplizna. For neuromyelitis optica spectrum disorder (NMOSD), the member must be anti-aquaporin-4 (AQP4) antibody positive, show one of the listed core clinical characteristics, and not receive other biologics for NMOSD. Continuation of therapy requires no evidence of unacceptable toxicity or disease progression and a positive response to therapy for each indication. Aetna considers eculizumab experimental, investigational or unproven for other indications, including IgA nephropathy, lupus nephritis, systemic lupus erythematosus and Guillain-Barre syndrome. Soliris, Bkemv and Epysqli are not indicated for Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
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