OBJECTIVES: Gastro-oesophageal reflux disease (GORD) is common in the European population. In Sweden, proton pump inhibitors (PPIs) are the standard treatment, with Nissen fundoplication as the standard of care surgical option for selected cases. RefluxStop is a device emerging as an alternative surgical option. The objective of this analysis was to evaluate the cost-effectiveness of RefluxStop compared to Nissen fundoplication and PPIs.

METHODS: A Markov model was developed based on a recent publication for the UK NHS to assess cost-effectiveness of RefluxStop against other treatments. The healthcare payer's perspective was adopted with a lifetime horizon, one-month cycle length, and 3% annual discount rate utilised. Health states included initial PPI use, PPI relapse, follow-on surgery, reoperations, higher-dose PPI, Barrett's esophagus, esophageal cancer, and death. The model incorporated adverse events associated with PPIs and surgeries, while benefits were measured in quality-adjusted life-years (QALYs). Unit costs were derived from Swedish diagnostic-related group tariffs and from medical literature. Clinical efficacy data came from publications in the literature. Uncertainty was explored through deterministic and probabilistic sensitivity analyses.

RESULTS: The lifetime difference in costs for RefluxStop relative to PPIs and Nissen fundoplication were SEK 86,684 and SEK 42,523 per person, while the difference in QALYs per patient gained were 1.80 and 0.68, respectively. Thus, the base case incremental cost-effectiveness ratios (ICERs) for RefluxStop compared to PPIs and Nissen fundoplication were SEK 48,152 and SEK 62,966 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 100% and 96% against PPIs and Nissen fundoplication, respectively. Model results remained robust with sensitivity analysis. In a scenario analysis with a 10-year time horizon, RefluxStop remained cost-effective compared to other options.

CONCLUSIONS: RefluxStop demonstrates strong potential as a cost-effective treatment for GORD in Sweden.