Cost-effectiveness Analysis of Robotic Versus Open Pancreatoduodenectomy (DIPLOMA-2) A Multicenter International Randomized Trial

Background: – Although robot-assisted pancreatoduodenectomy (RPD) enhances patient recovery, it could be associated with higher costs than open pancreatoduodenectomy (OPD), potentially limiting its widespread adoption. High-level evidence comparing costs of RPD and OPD is lacking. This analysis in a randomized trial compared costs and cost-effectiveness between RPD and OPD. Methods: – Predefined cost-effectiveness analysis in the international randomized DIPLOMA-2 trial (ISRCTN27483786) comparing RPD and OPD in patients with primary resectable neoplasm in 14 centers in 6 European countries (2022–2023). Primary outcomes were mean total hospital costs (euro) at 6 months postoperatively and cost-effectiveness based on costs per quality-adjusted life year (QALY; incremental cost-utility ratio). Three analyses were performed: (1) costs, (2) QALYs including Health-Related Quality of Life (HR-QoL), and (3) cost-effectiveness with probabilities at various willingness-to-pay (WTP) thresholds. Results: – Overall, 268 patients were included (170 RPD, 98 OPD). No significant difference in total hospital costs was found between RPD and OPD (€30, 956 vs. €28, 271, P=0.538). The intraoperative costs were €5, 491 higher with RPD (€11, 906 vs. €6, 451, P<0.001), whereas postoperative costs were €2806 lower (€19, 051 vs. €21, 856, P=0.518). The HR-QoL index scores were comparable at 1 and 3 months, but worse at 6 months with RPD (Δ−0.08 [−0.15 to −0.001]). Consequently, over 6 months a QALY loss was observed with RPD (Δ−0.02 [−0.07 to 0.01]) with a <30% probability of RPD being cost-effective across various WTP thresholds. Conclusion: – This analysis in a randomized trial found no significant differences in costs between RPD and OPD up to 6 months. Nonsignificantly lower QALYs at 6 months with RPD resulted in a <30% probability that RPD is cost-effective compared with OPD within 6 months after surgery in selected patients in high-volume centers.