Objective: We evaluated the cost-effectiveness of Tisagenlecleucel (CD19CAR-T cells) versus salvage chemotherapy followed by hematopoietic cell transplantation in treating diffuse large b-cell lymphoma (DLBCL) patients who are refractory or relapsed after 2 or more lines of therapy from the US societal perspective.

Methods: A three-state (progression-free survival, progressive disease, death) partitioned survival model was adopted after the decision tree over a lifetime horizon. Using the DEALE method for approximation of life expectancy, transitional probabilities were extrapolated from the JULIET clinical trial [NCT02445248] (median follow-up of 40 months) and the SCHOLAR-1 study. We hypothesized the curative potential of tisagenlecleucel, so patients who remain in the progression-free survival state after 40 months were assumed to be equivalent to long-term DLBCL survivors. Utilities were obtained from the JULIET trial, and costs were based on literature, Centers for Medicare and Medicaid, and Healthcare Cost and Utilization Project. We reported discounted total costs and quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER), and incremental net monetary benefit, using a 3% annual discount rate on cost and effectiveness. One-way sensitivity analyses (OSA), scenario analyses, and probabilistic sensitivity analysis (PSA) were conducted to test uncertainties and assumptions. All costs were adjusted to 2021 US dollars.

Results: Tisagenlecleucel was associated with incremental costs of $255,203 and incremental QALYs of 3.12 compared to salvage treatment, resulting in an ICER of $81,739/QALY. OSA showed that the model’s results were affected mostly by the utility of progressive disease, constant hazard ratio assumption to progression-free survival of SCHOLAR-1, and overall response rate of tisagenlecleucel. PSA suggested that tisagenlecleucel is cost-effective 68% at the willingness-to-pay (WTP) of $100,000/QALY and 85% at WTP of $150,000/QALY.

Conclusion: Our analysis demonstrates that tisagenlecleucel is cost-effective in treating DLBCL patients who are refractory or relapsed after 2 or more lines of therapy at the WTP of $100,000/QALY.