Cost-effectiveness of RefluxStop for gastroesophageal reflux disease: analysis from an Italian healthcare perspective

Abstract Objectives Gastroesophageal 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. Methods A 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. Results RefluxStop 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. Conclusion The 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.