Cost-utility analysis of CAR-T therapy compared to standard of care in patients with relapsed/refractory diffuse large B-cell lymphoma in Colombia, 2025.

BACKGROUND: Chimeric Antigen Receptor T-cell (CAR-T) therapy has changed the treatment landscape for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Although its clinical effectiveness has been demonstrated, the cost of CAR-T is concerning, given its accessibility and sustainability, especially in countries with intermediate incomes such as Colombia. OBJECTIVE: Assess the cost-utility of CAR-T therapy relative to conventional salvage chemotherapy from the perspective of the Colombian health system. METHODS: A cost-utility analysis was performed using a state-transition (Markov) model with a 10-year horizon and monthly cycles. The costs were estimated from Colombian tariff manuals (ISS, SOAT), adjusted to 2025 values. Effectiveness was measured by quality-adjusted life-years (QALYs) from clinical trial data (ZUMA-1, JULIET) and literature-based utilities. Both costs and outcomes were discounted by 3% annually. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The QALYs generated by CAR-T therapy were 4.5 versus 2.0 QALYs from standard chemotherapy, an incremental enhancement of 2.5 QALYs. Total costs were COP 1,825,000,000 for CAR-T and COP 14,825,906 for conventional treatment. The ICER obtained was COP 724,069,638/QALY, which is higher than commonly referenced Colombian willingness-to-pay (WTP) thresholds (COP 25-75 million/QALY). The sensitivity analyses validated that the cost of acquiring CAR-T is the primary driver of the ICER. CONCLUSION: CAR-T therapy gives substantial clinical benefits but is not cost-effective at current prices in Colombia. Affordability requires significant price reductions or alternative reimbursement strategies.