OBJECTIVES: The high prevalence and chronic nature of gastro-oesophageal reflux disease (GORD) generate high treatment costs. In Italy, standard medical treatment is initiated with proton pump inhibitors (PPIs), progressing to surgical treatment—primarily Nissen fundoplication or magnetic sphincter augmentation (MSA)—in a subgroup of patients. An emergent surgical treatment involving implantation of a non-active device, RefluxStop, was assessed for cost effectiveness against standard of care: PPIs, Nissen fundoplication, and MSA.

METHODS: Adapting a recently developed model for the UK National Health Service, a Markov model was constructed to incorporate a lifetime horizon, one-month cycle length, and 3% annual discount rate, from the Italian healthcare payer's perspective. The model included health states of initial PPI use, PPI relapse, follow-on surgery, reoperation, higher-dose PPI, Barrett's oesophagus, oesophageal cancer, and death. Adverse events associated with PPIs and surgeries were incorporated, and benefits were quantified in quality-adjusted life-years (QALYs). Unit costs were derived from Italian diagnostic-related group (DRG) tariffs and medical literature. Published literature was also used to provide clinical efficacy data. Deterministic and probabilistic sensitivity analyses were performed to evaluate uncertainty.

RESULTS: RefluxStop demonstrated a lifetime cost difference, relative to PPIs, Nissen fundoplication, and MSA, respectively, of EUR 8,788, EUR 5,312, and EUR 376 per person. The difference in QALYs gained per patient was 2.87, 0.79, and 2.20; the corresponding incremental cost-effectiveness ratios (ICERs) using the base case were EUR 3,067, EUR 6,712, and EUR 171 per QALY gained, respectively against PPIs, Nissen, and MSA. At the cost-effectiveness threshold of EUR 50,000 per QALY gained, the model demonstrated a high probability of cost-effectiveness of RefluxStop against PPIs (100%), Nissen fundoplication (97%), and MSA (100%). Sensitivity analysis confirmed the model’s robustness. Cost-effectiveness was maintained on a 10-year time horizon analysis.

CONCLUSIONS: RefluxStop is highly cost-effective against standard medical and surgical options for GORD in Italy.