Abstract

Abstract Background Gastro-oesophageal reflux disease (GORD) is a common gastrointestinal condition characterized by heartburn, chest pain, and regurgitation. Chronic treatment with proton pump inhibitor (PPI)-based medical management is the current standard of care, with antireflux surgery considered in selected patients. RefluxStop is a novel implantable device indicated for patients eligible for laparoscopic anti-reflux surgery. The purpose of this analysis was to assess the cost-effectiveness of RefluxStop against other GORD treatment options in the UK. Methods A Markov model was developed to assess the cost-effectiveness of RefluxStop compared with PPI-based medical management, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation (MSA) for management of GORD. The UK National Health Service perspective was adopted, with clinical outcomes and costs estimated over a lifetime horizon and an annual discount rate of 3.5% applied. Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Results RefluxStop demonstrated favorable surgical outcomes compared to both laparoscopic Nissen fundoplication and MSA. The base case incremental cost-effectiveness ratios (ICERs) compared with PPIs, laparoscopic Nissen fundoplication, and MSA were £4,156, £6,517, and £249 per quality-adjusted life-year (QALY) gained, respectively. With a UK cost-effectiveness threshold of £20,000 per QALY gained, the probabilities that RefluxStop was cost-effective compared with PPIs, laparoscopic Nissen fundoplication, and MSA were 100%, 93%, and 100%, respectively. Conclusions Based on this analysis, RefluxStop was estimated to improve quality of life and extend life expectancy in GORD patients when compared to PPIs, laparoscopic Nissen fundoplication, and MSA. Furthermore, this analysis demonstrated that RefluxStop is highly likely to be a cost-effective option for treating GORD in the UK.

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