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…
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