Cost-effectiveness of Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery: Economic Evaluation alongside the IntAct Randomised Controlled Trial

BackgroundAnastomotic leakage (AL) following resection for rectal cancer has a significant negative impact on patients and represents a substantial economic burden. Intraoperative fluorescence angiography using indocyanine green (ICG+) is a potential strategy to reduce ALs. Findings from recent randomized controlled trials were positive; however, no full economic evaluations of ICG+ have been conducted to date. We conducted a cost-utility analysis of the ICG+ vs standard surgeon assessment (ICG-) using the IntAct trial data. MethodsWe took the perspective of the UK NHS over a 90-day post procedure horizon. EQ-5D-5L and resource use data were collected at baseline, 30 and 90 days in the UK trial sub-sample to enable estimation of quality-adjusted life years (QALYs) and costs. Incremental cost-effectiveness ratios (ICERs) were estimated using generalised linear regression models. ResultsWe analysed data from n=345 UK patients finding negligible adjusted differences in QALYs (-0.001 in the primary multiply imputed analysis) at 90 days but modest cost savings ({pound}73 [95% CI -{pound}78, -{pound}67] for the primary and {pound}140 [95% CI -{pound}150, -{pound}129] for the secondary complete case analyses) per patient for ICG+. The ICER primary analysis indicated ICG+ was cost effective. Simulations indicated ICG+ had a 60% chance of being the optimal strategy in the primary analysis. ConclusionsThis research represents a novel contribution on the value of ICG+ for preventing ALs. Results indicate that ICG+ leads to modest cost savings. Together with the clinical effectiveness results, and the potential positive budget impact, the current results indicate ICG+ is likely to provide net health benefit.