Cost-Effectiveness Analysis of Axicabtagene Ciloleucel vs. Standard of Care in Second-Line Treatment for Relapsed/Refractory Large B-Cell Lymphoma in Spain.

Simple Summary: At least 40% of treated patients with large B-cell lymphoma do not respond to first-line treatment or experience disease recurrence, and less than 50% of patients respond to second-line salvage immunochemotherapy and can proceed to the historical standard of care of autologous stem-cell transplantation (ASCT). This study aimed to assess the cost-effectiveness of axicabtagene ciloleucel compared to salvage immunochemotherapy followed by high-dose chemotherapy (HDT) and ASCT for the treatment of large B-cell lymphoma in second-line patients in Spain. Compared to patients treated with HDT+ASCT, patients treated with axicabtagene ciloleucel experienced improvements in health outcomes in terms of life years gained (LYG) (+1.72) and quality-adjusted life years (QALYs) (+1.81). The incremental cost–utility ratio of axicabtagene ciloleucel versus HDT+ASCT was 47,309 EUR/QALY. Axicabtagene ciloleucel could be a cost-effective option that addresses an unmet clinical need for the treatment of relapsed/refractory large B-cell lymphoma after first-line treatment. Purpose: To estimate the cost-effectiveness of axi-cel vs. salvage immunochemotherapy followed by high-dose chemotherapy and autologous stem-cell transplantation (HDT+ASCT) for responders to second-line treatment for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Methods: A partitioned survival mixture-cure model comprising three health states was used to estimate the costs, life years gained (LYG), and quality-adjusted life years (QALYs) accumulated over a lifetime horizon. Overall survival, event-free survival, and time to the next treatment with axi-cel and HDT+ASCT were derived from the ZUMA-7 study. The total costs (EUR, 2022) included drug acquisition and administration, ASCT, subsequent treatment, disease and adverse event management, and palliative care. The unitary costs were derived from local databases and the literature. A 3% discount rate was applied to the costs and outcomes. Results: Compared with HDT+ASCT, axi-cel provided higher LYG per patient (10.00 vs. 8.28 LYG/patient) and greater QALYs gained per patient (7.85 vs. 6.04 QALY/patient). The lifetime total costs were 343,581 EUR/patient with axi-cel vs. 257,994 EUR/patient with IQT+ASCT. The incremental cost-effectiveness ratio of axi-cel vs. HDT+ASCT was 49,627 EUR/LYG, and the incremental cost-utility ratio was 47,309 EUR/QALY. Sensitivity analyses confirmed the robustness of the model. Conclusion: Axi-cel is a potentially cost-effective alternative to HDT+ASCT for the treatment of R/R DLBCL in Spain. [ABSTRACT FROM AUTHOR]