A cost-effectiveness analysis of RefluxStop against relevant therapeutic alternatives for chronic gastroesophageal reflux disease in Sweden.

The standard treatment for gastroesophageal reflux disease (GERD) is proton pump inhibitors (PPIs). In selected cases, Nissen fundoplication is offered as a surgical treatment option, but alternative endoscopic and minimally invasive surgical alternatives are emerging. RefluxStop is a new technology for the treatment of GERD. A cost-effectiveness analysis of RefluxStop in comparison to PPI therapy and Nissen fundoplication in the Swedish healthcare setting was conducted using a Markov model and available comprehensive population and clinical trial-based long-term data. Benefits were measured in quality-adjusted life-years (QALYs). Uncertainty was determined by deterministic and probabilistic sensitivity analyses. The base case incremental cost-effectiveness ratios (ICERs) for RefluxStop in comparison to PPIs and Nissen fundoplications were SEK 48,152 (€ 4,531) and SEK 62,966 (€ 5,925) per QALY gained, respectively. At a cost-effectiveness threshold of SEK 500,000 per QALY gained, RefluxStop has a high likelihood of being cost-effective, with probabilities of 96% and 100% against Nissen fundoplication and PPIs, respectively. The results of the model remained robust with sensitivity analysis. RefluxStop may offer a highly cost-effective long-term treatment alternative for chronic GERD patients over lifelong PPI therapy, but also in comparison with laparoscopic Nissen fundoplication. Gastroesophageal reflux disease (GERD) is typically managed by proton pump inhibitor (PPI)-based medical management or antireflux surgery (i.e. Nissen fundoplication) in selected cases. However, alternative endoscopic and minimally invasive surgical alternatives have emerged. RefluxStop is a novel implantable device that aims to treat chronic GERD. We performed a cost-effectiveness analysis of RefluxStop from the perspective of the Swedish healthcare system including available treatment options in Sweden (i.e. PPI therapy and Nissen fundoplication). Benefits were measured using quality-adjusted life-years (QALYs). At the cost-effectiveness threshold of SEK 500,000 per QALY gained for Sweden, RefluxStop demonstrated a high likelihood of cost-effectiveness, with probabilities of 96% and 100% against Nissen fundoplication and PPI therapy, respectively. RefluxStop is likely to be a highly cost-effective long-term treatment alternative for chronic GERD patients as compared to lifelong PPI therapy and laparoscopic Nissen fundoplication.