Sutimlimab-jome (Enjaymo®)

Coverage is limited to the FDA‑approved indication—treatment of cold agglutinin disease—and excludes use for other indications or for patients who do not meet all specified criteria. Key requirements: age ≥18, weight ≥39 kg, documented CAD signs/symptoms and chronic hemolysis, DAT strongly positive for C3d with negative/weak IgG, cold agglutinin titer ≥64 at 4°C, baseline hemoglobin ≤10 g/dL and total bilirubin above lab ULN, exclusion of secondary causes, prescribed by/with a hematologist, approval for 1 year with weight‑based IV dosing (6,500 mg for 39–75 kg or 7,500 mg for >75 kg: weekly ×2 then every 2 weeks).

"Enjaymo is indicated for the treatment of individuals with cold agglutinin disease."

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