简介:西方社会最普遍的疾病之一是胃食管反流病(GERD)。在瑞士,GERD的标准治疗是基于质子泵抑制剂(PPI)的医疗管理,但Nissen胃底折叠术和MSA系统等手术选择是可用的。RefluxStop是一种新颖的设备,提供了一种替代解决方案。本报告的目的是评估RefluxStop与PPI和现有手术治疗相比的成本效益。方法:使用瑞士医疗保健支付者的观点开发了一个模型(马尔可夫),一个月的周期长度,以及每年3%的成本和收益折现率。纳入治疗组特有的不良事件,和益处以质量调整寿命年(QALYs)衡量。RefluxStop的临床疗效数据来自其CE标记研究,和比较治疗基于已发表的文献。使用确定性和概率敏感性分析来探索不确定性。由于RefluxStop和PPI治疗之间没有正面研究,尼森胃底折叠术,或MSA,这项研究的一个局限性是使用天真,间接比较研究的治疗方案之间的临床有效性。结果:与Nissen胃底折叠术和LINX系统相比,RefluxStop提供了更高的QALY和更低的成本。与基于PPI的医疗管理相比,RefluxStop的增量成本效益比(ICER)为2,116瑞士法郎。在获得的每QALY100,000瑞士法郎的成本效益阈值下,RefluxStop具有成本效益的可能性很高,概率为100%,97%,100%反对基于PPI的医疗管理,尼森胃底折叠术,和MSA,分别。通过确定性和概率敏感性分析提供了分析的稳健性。结论:这项成本效益分析表明,与瑞士其他可用的治疗方案相比,RefluxStop很有可能成为GERD成人患者的一种具有成本效益的治疗方式。
胃食管反流病(GERD)是西方社会最普遍的疾病之一。瑞士的标准治疗需要基于质子泵抑制剂(PPI)的医疗管理或手术选择(即,Nissen胃底折叠术和磁性括约肌增强[MSA])。RefluxStop是一项用于GERD手术治疗的新技术,可恢复抗反流屏障的正常解剖结构。RefluxStop的临床益处和货币成本必须与可用的治疗方案进行权衡,以确定这项新技术在瑞士的作用。成本效益分析比较了在患者旅程中采用不同路径时疾病管理的相对成本和临床结果。按质量调整寿命年(QALYs)衡量。在本研究中,RefluxStop与Nissen胃底折叠术相比,和MSA,提供更高的QALY和更低的成本。反对PPI治疗,成本略高,但QALY也更高,产生有利的增量成本效益比。此外,在每QALY获得100,000瑞士法郎的成本效益阈值下,与PPI治疗相比,RefluxStop极有可能具有成本效益,尼森胃底折叠术,概率为100%的MSA,97%,100%,分别。最终,这种成本效益分析表明,RefluxStop作为GERD治疗在瑞士与其他治疗方案相比,具有很高的成本效益。即使在额外的敏感性分析中考虑了不确定性,结果也是稳健的。
UNASSIGNED: One of the most prevalent conditions in Western societies is gastroesophageal reflux disease (GERD). In Switzerland, the standard treatment for GERD is proton pump inhibitor (PPI)-based medical management, but surgical options such as Nissen fundoplication and magnetic sphincter augmentation (MSA) are available. RefluxStop is a novel device that offers an alternative solution. The purpose of this report is to evaluate the cost-effectiveness of RefluxStop compared to PPIs and existing surgical treatments.
UNASSIGNED: A model (Markov) was developed using the Swiss healthcare payer perspective with a lifetime horizon, 1-month cycle length, and a 3% annual discount rate for costs and benefits. Adverse events specific to treatment arms were incorporated, and benefits were measured in quality-adjusted life-years (QALYs). Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Deterministic and probabilistic sensitivity analyses were used to explore uncertainty. Since there are no head-to-head studies between RefluxStop and PPI therapy, Nissen fundoplication, or MSA, a limitation of this study is the use of naïve, indirect comparison of clinical effectiveness between the studied treatment options.
UNASSIGNED: Higher QALYs and lower costs were provided by RefluxStop compared to Nissen fundoplication and the MSA system. The incremental cost-effectiveness ratio (ICER) for RefluxStop was CHF 2,116 in comparison to PPI-based medical management. At a cost-effectiveness threshold of CHF 100,000 per QALY gained, the probability of RefluxStop being cost-effective was high, with probabilities of 100%, 97%, and 100% against PPI-based medical management, Nissen fundoplication, and MSA, respectively. The robustness of the analysis was provided by deterministic and probabilistic sensitivity analyses.
UNASSIGNED: This cost-effectiveness analysis demonstrates that there is a high likelihood of RefluxStop being a cost-effective treatment modality in adults with GERD when compared with other treatment options available in Switzerland.
Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions in Western societies. Standard treatment in Switzerland entails proton pump inhibitor (PPI)-based medical management or surgical options (i.e., Nissen fundoplication and magnetic sphincter augmentation [MSA]) in selected cases. RefluxStop is a new technology indicated for the surgical treatment of GERD that restores the normal anatomy of the anti-reflux barrier. The clinical benefits and monetary costs of RefluxStop must be weighed against available treatment options to determine the role of this new technology in Switzerland. Cost-effectiveness analyses compare the relative costs and clinical outcomes of disease management when pursuing different paths in the patient journey landscape, as measured by quality-adjusted life-years (QALYs). In the present study, RefluxStop in comparison to Nissen fundoplication, and MSA, provided higher QALYs and lower costs. Against PPI therapy, the costs were slightly higher but the QALYs were also higher, generating a favourable Incremental cost-effectiveness ratio. Furthermore, at the cost-effectiveness threshold of CHF 100,000 per QALY gained, RefluxStop was highly likely to be cost-effective in comparison to PPI therapy, Nissen fundoplication, and MSA with probabilities of 100%, 97%, and 100%, respectively. Ultimately, this cost-effectiveness analysis showed that RefluxStop has a high likelihood of cost-effectiveness as a GERD treatment in Switzerland against other treatment options, with results being robust even with uncertainties considered in additional sensitivity analyses.