ArticleBMC gastroenterology2026
Cost-effectiveness of RefluxStop for gastroesophageal reflux disease: analysis from an Italian healthcare perspective.
Article in BMC gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Abstract
objectivesGastroesophageal reflux disease (GERD) is estimated to affect up to one-quarter of the Italian population, generating immense treatment costs. An emergent surgical treatment involving implantation of a nonactive device, RefluxStop, is offered at a number of hospitals in Italy and several other European countries. Published clinical outcomes of this device from the Conformité Européenne (CE)-mark clinical trial and real-world settings are consistently encouraging and with a favorable safety profile. This study evaluated the cost-effectiveness of RefluxStop compared with the current medical and surgical standards of care in Italy.
methodsA Markov model recently developed for use in the United Kingdom was adapted to the Italian healthcare payer’s perspective, covering the GERD treatment field. The model incorporated a lifetime horizon, one-month cycle length, and a 3% annual discount rate. Standards of care to be compared to the RefluxStop procedure included proton pump inhibitor (PPI)-based medical management, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation (MSA). The mutually exclusive health states of the model comprised PPI use, PPI relapse, follow-on surgery, reoperation, high-dose PPI, Barrett’s esophagus, esophageal cancer, and death. The model included adverse events (AEs) associated with PPIs and surgeries and quantified the benefits in terms of quality-adjusted life years (QALYs). Unit costs were derived from the Italian diagnosis-related group (DRG) tariffs and the literature. Additional clinical efficacy data on standard-of-care treatments were derived from published literature. Model uncertainty was evaluated using deterministic and probabilistic sensitivity analyses.
resultsRefluxStop demonstrated a lifetime cost difference relative to PPIs, Nissen fundoplication, and MSA of €8,788, €5,312, and €376 per patient, respectively. The corresponding QALY gains per patient were 2.87, 0.79, and 2.20, respectively. Base-case analysis established corresponding incremental cost-effectiveness ratios (ICERs) of €3,067, €6,712, and €171 per QALY gained, against PPIs, Nissen fundoplication, and MSA, respectively. At a cost-effectiveness threshold of €50,000 per QALY gained, RefluxStop was predicted to be cost-effective against both PPIs and MSA with a probability of 100% and against Nissen fundoplication with a probability of 97%. Sensitivity analysis confirmed the robustness of the model.
conclusionThe implementation of RefluxStop in the Italian national health service is highly likely to be cost-effective compared to standard medical and surgical options for GERD, providing an opportunity for healthcare optimization in Italy.
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