OBJECTIVES: Gastro-oesophageal reflux disease (GORD) remains highly prevalent in Europe. In Spain, proton pump inhibitors (PPIs) are the standard medical treatment, and Nissen fundoplication, the standard-of-care surgical treatment. The RefluxStop device is an emerging surgical alternative. This analysis evaluated the cost-effectiveness of RefluxStop comparing against PPIs and Nissen fundoplication.

METHODS: A Markov model to assess cost-effectiveness of RefluxStop versus other treatments was adapted based on a recent publication for the UK National Health Service. The model adopted the healthcare payer's perspective of Spain, using a one-month cycle length, a lifetime horizon, and a 3% annual discount rate. The health states comprised PPI use, PPI relapse, follow-on surgery, reoperation, increased-dose PPI, Barrett's oesophagus, oesophageal cancer, and death. Adverse events associated with PPIs and surgery were incorporated; benefits were measured in quality-adjusted life-years (QALYs). Unit costs were derived from Spanish diagnostic-related group (DRG) tariffs and medical literature. Clinical efficacy data were sourced from published literature. Uncertainty was explored through probabilistic and deterministic sensitivity analyses.

RESULTS: Over a lifetime horizon, the cost difference for RefluxStop versus PPIs and Nissen fundoplication was EUR 1,472 and EUR 2,111 per person, and the difference in QALYs gained per patient was 2.64 and 0.88, respectively. Using the base case, the incremental cost-effectiveness ratios (ICERs) for RefluxStop compared to standard care were EUR 557 per QALY gained against PPIs and EUR 2,393 per QALY gained against Nissen. Taking a cost-effectiveness threshold of EUR 30,000 per QALY gained, the likelihood of RefluxStop being cost-effective was high, with a probability of 100% against PPIs and 95% against Nissen fundoplication. The model results remained robust on sensitivity analysis. Analysis using a 10-year time horizon showed that RefluxStop remained cost-effective compared to standard of care.

CONCLUSIONS: RefluxStop treatment for GORD is highly likely a cost-effective surgical option in Spain.