OBJECTIVES: Gastroesophageal reflux disease (GORD) is a disease characterised by heartburn, chest pain, difficulty swallowing and regurgitation of food. Standard treatment is the prescription of a proton pump inhibitor (PPI). The treatment options for people who fail medical treatment include the Nissen fundoplication and LINX system reflux treatment. RefluxStop is an implantable single-use device implanted during laparoscopic surgery. We looked to evaluate the cost-effectiveness of RefluxStop compared with the currently available surgical treatments and medical management (MM).

METHODS: A state transition (Markov) model was designed to compare the cost-effectiveness of RefluxStop and the three treatment options. The model used the UK National Health Service perspective, a lifetime time horizon, a one-month cycle length and a discount rate of 3.5% p.a. for costs and benefits. Health states include ‘initial MM’, ‘MM relapse’, ‘follow-on surgery’ (including surgical success and failure), ‘reoperations’, ‘MM with a higher dose’, ‘Barrett’s oesophagus’, ‘oesophageal cancer’ and ‘death’. The model structure also included adverse events associated with MM and surgeries (intra-operative and post-operative events). Benefits were expressed as quality-adjusted life-years (QALYs) and unit costs taken from appropriate national databases and medical literature. The clinical efficacy of RefluxStop was taken from an ongoing clinical study and data for the comparator treatments from published economic evaluations. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses.

RESULTS: The base case incremental cost-effectiveness ratios (ICERs) compared with MM, Nissen and LINX were £4,289, £6,752 and £459 per QALY gained, respectively. At a cost-effectiveness threshold of £20,000 per QALY gained, the probability that RefluxStop was cost-effective against MM, Nissen and LINX was 100%, 93% and 100%, respectively. In the deterministic sensitivity analyses, no plausible alterations of parameter values generated an ICER higher than £20,000 per QALY gained.

CONCLUSIONS: RefluxStop is highly likely to be a cost-effective treatment for GORD.