First-line enfortumab vedotin-pembrolizumab versus nivolumab plus gemcitabine-cisplatin in metastatic urothelial cancer: a cost-effectiveness study.

[INTRODUCTION] Recent phase III programs, EV-302 and CheckMate-901, showed that enfortumab vedotin plus pembrolizumab (EV + P) and nivolumab with gemcitabine-cisplatin (N + GC) deliver superior clinical outcomes when used as initial therapy for advanced urothelial cancer. What remains uncertain is their relative economic value when assessed under Chinese and US payer conditions. To address this gap, we compared the value for money of EV + P versus N + GC as first-line management for la/mUC from the perspectives of healthcare payers in China and the US.

[METHODS] We performed a model-based economic evaluation using a time-dependent state-transition framework implemented in TreeAge Pro (2022). Health benefits were measured as quality-adjusted life-years (QALYs) derived from health-state utilities, and comparative value was expressed as incremental cost-effectiveness ratios (ICER). The robustness of the model was assessed through one-way sensitivity analysis (OWSA) to evaluate the impact of key parameter uncertainties.

[RESULTS] In the US, EV + P cost $1,863,624.32 and provided 3.34 QALYs, while N + GC cost $881,979.07 for 2.36 QALYs, resulting in an ICER of $1,001,626.19 per QALY, exceeding the $150,000/QALY threshold. In China, EV + P cost $485,374.69 and provided 2.95 QALYs, compared to $203,811.61 for 2.15 QALYs with N + GC, yielding an ICER of $351,960.68/QALY, above the $40,451.64/QALY threshold. Therefore, N + GC is the more cost-effective first-line strategy in both countries.

[CONCLUSION] Under current pricing and reimbursement assumptions, N + GC is economically preferable to EV + P as a first-line strategy for la/mUC in both the US and China. EV + P may warrant consideration only in tightly selected scenarios or with substantial coordinated price reductions and policy changes. Meanwhile, it should be noted that due to the inherent limitations of the indirect comparison method between drugs, the conclusions of this study should be regarded as exploratory analysis results.