Cost-Effectiveness of second-line lisocabtagene maraleucel in relapsed or refractory diffuse large B-cell lymphoma.

Lisocabtagene maraleucel (liso-cel), a chimeric antigen receptor (CAR) T-cell therapy, received FDA approval in 2022 for second-line treatment of diffuse large B-cell lymphoma (DLBCL) in patients with refractory disease or early relapse following first-line chemoimmuno-therapy. This decision was influenced by the TRANSFORM study demonstrating improvements in event-free survival with liso-cel compared to standard care. Given the substantial costs associat-ed with CAR T-cell therapies, particularly as they transition to second-line treatment, a cost-effectiveness analysis is essential to accurately determine their economic viability. The study em-ployed a partitioned survival model using standard parametric functions over a lifetime horizon to evaluate the cost-effectiveness of liso-cel versus platinum-based chemotherapy followed by autolo-gous hematopoietic stem cell transplantation. Integrating data from the TRANSFORM and TRANSCEND trials, along with established literature and public datasets, the study calculated the incremental cost-effectiveness ratio (ICER). For a representative cohort of 60-year-old US adults, liso-cel's ICER was $99,669 per quality-adjusted life-year (QALY) from a healthcare sector perspective and $68,212 per QALY from a societal perspective, confirming its cost-effectiveness at $100,000 per QALY threshold. Nonetheless, under certain scenarios, liso-cel surpasses this benchmark but remains within the US acceptable range of $150,000 per QALY. This study is the first to analyze liso-cel's cost-effectiveness as a second-line therapy. A key finding underlines the importance of incorporating productivity losses into such analyses to capture the broader societal values of novel therapies. The study reveals that although these therapies offer substantial clinical benefits, their high acquisition costs and limited long-term data critically challenge their economic sustainability.