Enjaymo® (sutimlimab-jome)

Covers Enjaymo for treatment of hemolysis in adults with cold agglutinin disease (CAD) when all criteria are met and excludes use if criteria are not met (e.g., age <18, weight <39 kg, no CAD symptoms or chronic hemolysis, DAT not strongly C3d-positive/IgG negative or weak, cold agglutinin titer <64 at 4°C, baseline Hb >10 g/dL, total bilirubin ≤ULN, secondary causes not excluded, or not prescribed by/with a hematologist). Key requirements: documentation of age ≥18, weight ≥39 kg, ≥1 CAD symptom, evidence of chronic hemolysis, DAT strongly positive for C3d and negative/weak IgG, cold agglutinin titer ≥64 at 4°C, baseline Hb ≤10 g/dL and bilirubin above the lab ULN, exclusion of secondary causes, hematologist involvement, approval limited to 12 months with weight‑based IV dosing (7,500 mg for ≥75 kg; 6,500 mg for 39–<75 kg: weekly x2 then every 2 weeks).

"Enjaymo is indicated for the treatment of hemolysis in adults with cold agglutinin disease."