OBJECTIVES: Therapeutic landscape of LBCL RR≤12 is rapidly evolving, shifting from ASCT to CAR-T cell therapy. In France, liso-cel is available since September 2022 for LBCL RR≤12 as part of early access. The objective of this study was to assess the cost-effectiveness of liso-cel versus ASCT in this indication in France.

METHODS: A 3-state (event-free (EF), post-event (PE), death) semi-Markov model was developed. French healthcare system perspective and a 20-year-time horizon were selected. Costs (€2023, French-specific) and health outcomes were discounted by 2.5% annually. Acquisition cost of liso-cel was list price. Patients’ characteristics and EF survival (EFS) curves were obtained from the TRANSFORM trial (#NCT03575351) while overall survival (OS) curves were derived from DESCAR-T and SCHOLAR-1 studies. Survival was extrapolated over a 5-year period, after which patients were considered cured. Afterwards, sex and age adjusted French population mortality was applied to cured patients, increased by a 2.2 standardized mortality ratio.

Outcomes were life-years (LYs) gained, total and incremental costs, incremental cost-effectiveness ratio (ICER). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the results.

RESULTS: Liso-cel generated a total of 6.4 LYs (EF state: 5.6 LYs, PE state: 0.8 LYs) for a €381,775 total cost. ASCT generated a total of 5.1 LYs (EF state: 1.9 LYs, PE state: 3.2 LYs) for a €256,932 total cost. The incremental cost of liso-cel was €124,843 and the ICER was estimated at €91,531/LY gained versus ASCT. DSA showed that variables with the highest impact on the ICER were parameters of distributions extrapolating the EFS curves, treatments used for post-recurrence and OS extrapolations. PSA showed that liso-cel was more effective and more costly in 92% of the simulations.

CONCLUSIONS: Liso-cel is cost-effective versus ASCT to treat patients with LBCL RR≤12 in France. Generation of real-world data may confirm long-term outcomes and this result.