A cost-effectiveness analysis of RefluxStop against relevant therapeutic alternatives for chronic gastroesophageal reflux disease in Sweden

The standard treatment for gastroesophageal reflux disease (GERD) is proton pump inhibitors (PPIs). In selected cases, Nissen fundoplication is offered as a surgical treatment option, but alternative endoscopic and minimally invasive surgical alternatives are emerging. RefluxStop is a new technology for the treatment of GERD. A cost-effectiveness analysis of RefluxStop in comparison to PPI therapy and Nissen fundoplication in the Swedish healthcare setting was conducted using a Markov model and available comprehensive population and clinical trial-based long-term data. Benefits were measured in quality-adjusted life-years (QALYs). Uncertainty was determined by deterministic and probabilistic sensitivity analyses. The base case incremental cost-effectiveness ratios (ICERs) for RefluxStop in comparison to PPIs and Nissen fundoplications were SEK 48,152 (€ 4,531) and SEK 62,966 (€ 5,925) per QALY gained, respectively. At a cost-effectiveness threshold of SEK 500,000 per QALY gained, RefluxStop has a high likelihood of being cost-effective, with probabilities of 96% and 100% against Nissen fundoplication and PPIs, respectively. The results of the model remained robust with sensitivity analysis. RefluxStop may offer a highly cost-effective long-term treatment alternative for chronic GERD patients over lifelong PPI therapy, but also in comparison with laparoscopic Nissen fundoplication. Gastroesophageal reflux disease (GERD) is typically managed by proton pump inhibitor (PPI)-based medical management or antireflux surgery (i.e. Nissen fundoplication) in selected cases. However, alternative endoscopic and minimally invasive surgical alternatives have emerged. RefluxStop is a novel implantable device that aims to treat chronic GERD. We performed a cost-effectiveness analysis of RefluxStop from the perspective of the Swedish healthcare system including available treatment options in Sweden (i.e. PPI therapy and Nissen fundoplication). Benefits were measured using quality-adjusted life-years (QALYs). At the cost-effectiveness threshold of SEK 500,000 per QALY gained for Sweden, RefluxStop demonstrated a high likelihood of cost-effectiveness, with probabilities of 96% and 100% against Nissen fundoplication and PPI therapy, respectively. RefluxStop is likely to be a highly cost-effective long-term treatment alternative for chronic GERD patients as compared to lifelong PPI therapy and laparoscopic Nissen fundoplication.

胃食管反流病（gastroesophageal reflux disease, GERD）的标准治疗方案为质子泵抑制剂（proton pump inhibitors, PPIs）。针对特定病例，临床会采用尼森胃底折叠术作为外科治疗选择，但内镜下及微创外科替代疗法正逐渐兴起。RefluxStop是一款用于治疗胃食管反流病的新技术。本研究基于马尔可夫模型，结合瑞典医疗体系中可获取的全人群数据及基于临床试验的长期数据，开展了RefluxStop与质子泵抑制剂治疗、尼森胃底折叠术的成本效益分析。研究以质量调整生命年（quality-adjusted life-years, QALYs）作为效益衡量指标，通过确定性敏感性分析与概率敏感性分析评估结果的不确定性。以每获得1个质量调整生命年所需花费计算，RefluxStop对比质子泵抑制剂、尼森胃底折叠术的基础案例增量成本效益比（incremental cost-effectiveness ratios, ICERs）分别为每QALY 48152瑞典克朗（合4531欧元）与62966瑞典克朗（合5925欧元）。在瑞典每QALY 500000瑞典克朗的成本效益阈值下，RefluxStop具有较高的成本效益可行性：相较于尼森胃底折叠术与质子泵抑制剂治疗，其成本效益概率分别达96%与100%。敏感性分析结果显示本模型结论具有稳健性。相较于终身质子泵抑制剂治疗以及腹腔镜尼森胃底折叠术，RefluxStop可为慢性胃食管反流病患者提供极具成本效益的长期治疗选择。

胃食管反流病通常采用基于质子泵抑制剂的药物治疗，或针对特定病例采用抗反流外科手术（即尼森胃底折叠术）进行管理。不过目前已涌现出内镜下及微创外科替代疗法。RefluxStop是一款新型可植入装置，旨在治疗慢性胃食管反流病。本研究从瑞典医疗体系的视角出发，结合瑞典境内可用的治疗方案（即质子泵抑制剂治疗与尼森胃底折叠术）开展了RefluxStop的成本效益分析，以质量调整生命年作为效益衡量指标。在瑞典每QALY 500000瑞典克朗的成本效益阈值下，RefluxStop展现出较高的成本效益可行性：相较于尼森胃底折叠术与质子泵抑制剂治疗，其成本效益概率分别达96%与100%。相较于终身质子泵抑制剂治疗与腹腔镜尼森胃底折叠术，RefluxStop或可为慢性胃食管反流病患者提供极具成本效益的长期治疗选择。