ABSTRACT Objectives CAR‐T cell therapies such as lisocabtagene maraleucel (liso‐cel) have transformed the treatment of patients with second line primary refractory or early relapsed ≤ 12 months (R/R) large B‐cell lymphoma (LBCL). The objective of this study was to assess the cost‐effectiveness of liso‐cel compared to standard of care (SOC) to treat R/R LBCL in France. Methods A 3‐health‐state model was developed to compare liso‐cel to SOC over 20 years in France. Efficacy and safety were extrapolated from the TRANSFORM trial (NCT03575351), or DESCAR‐T (registry of patients treated with a CAR‐T in France). Costs were calculated using French‐specific sources. Outcomes were quality‐adjusted life years (QALY), life‐years (LY), total costs, incremental cost‐utility and cost‐effectiveness ratios (ICUR, ICER). Probabilistic sensitivity analysis (PSA) was conducted to assess the robustness of the results. Results Liso‐cel generated 5.7 QALY (6.4 LY) for a €265 907. SOC generated 4.4 QALY (5.1 LY) for €233 903. ICUR and ICER were estimated at €24 580/QALY and €23 464/LY gained versus SOC. PSA showed that liso‐cel was more effective and more costly in 92% of the simulations. Conclusions Liso‐cel is cost‐effective versus SOC to treat R/R LBCL patients in France. Generation of long‐term real‐world data is needed in order to validate these findings.
Thieblemont et al. (2026) studied this question.