OBJECTIVES: This study aimed to assess the cost-effectiveness of axicabtagene ciloleucel (axi-cel) versus the standard of care (SoC) treatment of adult patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after first-line chemoimmunotherapy, from the Spanish National Health System perspective.

METHODS: A partitioned survival mixture cure model (PS-MCM) comprising three health states (event-free, post-event and death) was used to estimate, in monthly cycles, the costs and outcomes (in terms of life-years gained [LYG] and quality-adjusted life-years [QALY]) accumulated over a lifetime horizon. The SoC comprised salvage chemotherapy followed by high-dose chemotherapy and autologous stem-cell transplantation (ASCT). Overall survival (OS), event-free survival and time to next treatment were derived from the ZUMA-7 study for axi-cel and SoC. QALY were estimated using utility values derived from literature. Total costs (€, 2023) included drug acquisition (official ex-factory price), drug administration, ASCT, subsequent treatment, adverse events management, disease management and palliative care. Unitary costs were derived from local databases and literature. A 3% discount rate was applied for costs and outcomes. Deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed.

RESULTS: Axi-cel provided higher LYG (10.00) and QALY gained per patient (7.85) than SoC (8.28 LYG/patient and 6.04 QALYs/patient), resulted in 1.72 incremental LYG and 1.81 incremental QALYs per patient. The lifetime total costs accounted €343,581/patient with axi-cel, versus €257,994/patient with SoC. The incremental cost-effectiveness ratio of axi-cel versus SoC were €49,627/LYG and the incremental cost-utility ratio €47,309/QALY. In the DSA, modelled OS curves for axi-cel and SoC had the greatest impact on cost-effectiveness. The PSA confirmed the robustness of the model.

CONCLUSIONS: Compared to SoC, axi-cel has shown an improvement in health outcomes in terms of LYG and QALY. Axi-cel is a potentially cost-effective alternative to SoC for the treatment of adults with R/R LBCL in Spain.