648 Background: The NIAGARA trial investigated the efficacy of adding perioperative durvalumab to standard gemcitabine/cisplatin chemotherapy in patients with muscle-invasive bladder cancer (MIBC). Given the increasing economic burden of urothelial carcinoma management and the favorable clinical outcomes reported in the NIAGARA trial, this study aimed to evaluate the cost-effectiveness of incorporating durvalumab into perioperative therapy from a German healthcare perspective. Methods: A Markov model was developed from the payer’s perspective using clinical outcomes from the NIAGARA trial. A Monte Carlo simulation was applied to identify the most cost-effective treatment strategy within the German healthcare context. Incremental cost-effectiveness ratios (ICERs) were calculated for each treatment approach across varying willingness-to-pay (WTP) thresholds. Results: The average cost of the standard-of-care (SoC) regimen was €113,224, compared with €126,386 for the durvalumab plus gemcitabine/cisplatin combination, resulting in an incremental cost of €13,162. The quality-adjusted life years (QALYs) were 3.16 for SoC and 3.37 for the combination therapy, corresponding to an incremental gain of 0.21 QALYs. The resulting ICER for the durvalumab-based regimen was €61,006 per QALY. At a WTP threshold of €100,000, the combination therapy was cost-effective in 76.5% of simulations. A substantial portion of total costs was attributed to expenses related to subsequent therapies in the metastatic disease setting. Conclusions: The addition of durvalumab to perioperative chemotherapy represents a cost-effective strategy for MIBC in Germany, primarily due to its potential to reduce the need for costly subsequent treatments. These findings suggest that intensified perioperative therapy may provide not only clinical benefits but also meaningful socioeconomic value within the German healthcare system. Base case analysis. Strategy Costs(€) Incremental costs (€) Effectiveness (QALY)/estimated life years Incremental effectiveness/estimated incremental life years ICER (€) SoC 113 224 3.16 Gemcitabine/Cisplatin + Durvalumab 126 386 13 162 3.37 0.21 61 006 The table summarizes the cost-effectiveness outcomes evaluated over a lifetime horizon. It outlines the mean cost and effectiveness per patient for each treatment strategy, along with the incremental cost and effectiveness relative to the Standard of Care. Furthermore, the table reports the corresponding Incremental Cost-Effectiveness Ratios (ICERs).
Rieger et al. (Sun,) studied this question.