Budget Impact Analysis of Refluxstop as a Treatment of Refractory Gastroesophageal Reflux Disease in Spain

OBJECTIVES: Current first-line treatment for gastroesophageal reflux disease (GORD) comprises medical management in the form of proton pump inhibitors (PPIs). In cases of medication intolerance or symptom persistence, surgical treatment may be indicated: in Spain, Nissen fundoplication is the gold standard. RefluxStop is a new antireflux surgery that involves implantation of an inactive device. This study assesses the budget impact for the Spanish national health system associated with the introduction of the RefluxStop procedure.

METHODS: This analysis, from the perspective of the Spanish national health system, used a time horizon of five years. Estimates for population growth projections were obtained from the Instituto Nacional de Estadística (National Institute of Statistics) database. Incidence and prevalence of GORD and the operative rate of laparoscopic anti-reflux surgery in the general population were taken from published literature. The existing market share of individuals necessitating either medical management or Nissen fundoplication, as well as the anticipated market share following the introduction of RefluxStop were derived from market research and foundational assumptions. Unit costs were taken from national databases and published literature. Scenario analyses were performed around key model inputs.

RESULTS: The overall one-year, three-year and five-year financial impacts of introducing RefluxStop were EUR 236,131, EUR 682,456 and EUR 951,938 per year, respectively. This corresponded to 0.03%, 0.10% and 0.15% increases in overall annual expenditure for GORD treatment in Spain. Analysis using more optimistic (doubled) and pessimistic (halved) market uptake rates of RefluxStop resulted in one-year increases in expenditure of 0.06% and 0.16% and five-year increases of 0.3% and 0.08%, respectively.

CONCLUSIONS: Considering the increasing financial burden of GORD to patients and the wider society, the introduction of RefluxStop, which yields a minimal budgetary impact, is likely an effective and economically acceptable surgical treatment option for the Spanish national health system.