Background <p>Gastroesophageal reflux disease (GERD) affects 6.8 million individuals in Spain, incurring €56 million/year in healthcare costs. Standard-of-care treatment (SOC) in Spain includes medical management with proton pump inhibitors (PPIs) and laparoscopic Nissen fundoplication (LNF) in selected cases. The limitations of PPIs, including high rates of unresponsiveness, adverse events (AEs) associated with long-term use, and nonindicative misuse, increase the economic strain on European healthcare systems. The durability of LNF treatment is hindered by reoperation and postoperative complications. RefluxStop, a novel implantable device, restores the anti-reflux barrier without encircling the esophagus and confers long-term efficacy and safety in the treatment of GERD.</p> Objective <p>This study assessed the cost-effectiveness of RefluxStop compared with medical (PPI-based) and surgical (LNF) SOC for refractory GERD in Spain.</p> Methods <p>The cost-effectiveness of RefluxStop versus PPI-based medical management and LNF was assessed from the Spanish National Health System (SNS) perspective over a lifetime horizon (monthly cycles, 3.0% annual discount rate). A Markov model adapted from a published UK National Health Service (NHS) cost-effectiveness analysis of this device was used. Quality-adjusted life years (QALYs) and total costs were calculated for each intervention, while inter-arm differences were evaluated using incremental cost-effectiveness ratios (ICERs).</p> Results <p>RefluxStop yielded ICERs of €557 and €2393 per QALY gained compared with medical management and LNF, respectively. At the cost-effectiveness threshold of €30,000 per QALY gained for Spain, the probability of RefluxStop being cost-effective was 100% compared with medical management and 93% compared with LNF. Over a lifetime horizon, the per-patient cost differences and QALY gains for RefluxStop were €1472 and 2.64 versus medical management and €2111 and 0.88 versus LNF, respectively. The model results remained robust to sensitivity analysis.</p> Conclusions <p>RefluxStop was estimated to be cost-effective relative to SOC in Spanish healthcare settings for the treatment of adult patients with refractory GERD, consistent with recently published findings in the UK, Switzerland, Sweden, and Norway. It is acknowledged that the model has limitations, including its reliance on single-arm trial data and indirect comparisons using heterogeneous literature sources, which limit the precision and generalizability of its findings.</p>