Abstract：
UNASSIGNED: To analyze the cost-effectiveness of transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (Edwards Lifesciences, Irvine, CA) compared to surgical aortic valve replacement (SAVR) in low- and intermediate-risk patients from a Japanese public healthcare payer perspective.
UNASSIGNED: A Markov model cost-effectiveness analysis was developed. Clinical and utility data were extracted from a systematic literature review. Cost inputs were obtained from analysis of the Medical Data Vision claims database and supplemented with a targeted literature search. The robustness of the results was assessed using sensitivity analyses. Scenario analyses were performed to determine the impact of lower mean age (77.5 years) and the effect of two different long-term mortality hazard ratios (TAVI versus SAVR: 0.9-1.09) on both risk-level populations. This analysis was conducted according to the guidelines for cost-effectiveness evaluation in Japan from Core 2 Health.
UNASSIGNED: In intermediate-risk patients, TAVI was a dominant procedure (TAVI had lower cost and higher effectiveness). In low-risk patients, the incremental cost effectiveness ratio (ICER) for TAVI was ¥750,417/quality-adjusted-life-years (QALY), which was below the cost-effectiveness threshold of ¥5 million/QALY. The ICER for TAVI was robust to all tested sensitivity and scenario analyses.
UNASSIGNED: TAVI was dominant and cost-effective compared to SAVR in intermediate- and low-risk patients, respectively. These results suggest that TAVI can provide meaningful value to Japanese patients relative to SAVR, at a reasonable incremental cost for patients at low surgical risk and potentially resulting in cost-savings in patients at intermediate surgical risk.
Aortic Stenosis (AS) is the most common valvular heart disease in Japan, and, if left untreated, severe symptomatic AS (sSAS) is associated with a dramatic increase in mortality and morbidity. Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive treatment option for replacing the aortic valve in patients with sSAS and has been associated with similar or better outcomes compared to Surgical Aortic Valve Replacement (SAVR), which involves open-heart surgical replacement of the aortic valve. The objective of this study was to compare the costs and health outcomes associated with TAVI compared to SAVR in Japanese patients deemed low- or intermediate-risk for surgery. Despite the expanding use of TAVI in Japan, a cost-effectiveness analysis (CEA) does not exist that evaluates the economics of TAVI with the current generation SAPIEN 3 implant in patients with low- and intermediate-risk from a public perspective. Our study suggests that TAVI represents strong value for money among low- and intermediate-risk patients in Japan: compared to SAVR, TAVI is associated with better clinical outcomes and quality of life for patients, at a reasonable additional cost for low-risk patients and at a lower cost for intermediate-risk patients.
UNASSIGNED: A Markov model cost-effectiveness analysis was developed. Clinical and utility data were extracted from a systematic literature review. Cost inputs were obtained from analysis of the Medical Data Vision claims database and supplemented with a targeted literature search. The robustness of the results was assessed using sensitivity analyses. Scenario analyses were performed to determine the impact of lower mean age (77.5 years) and the effect of two different long-term mortality hazard ratios (TAVI versus SAVR: 0.9-1.09) on both risk-level populations. This analysis was conducted according to the guidelines for cost-effectiveness evaluation in Japan from Core 2 Health.
UNASSIGNED: In intermediate-risk patients, TAVI was a dominant procedure (TAVI had lower cost and higher effectiveness). In low-risk patients, the incremental cost effectiveness ratio (ICER) for TAVI was ¥750,417/quality-adjusted-life-years (QALY), which was below the cost-effectiveness threshold of ¥5 million/QALY. The ICER for TAVI was robust to all tested sensitivity and scenario analyses.
UNASSIGNED: TAVI was dominant and cost-effective compared to SAVR in intermediate- and low-risk patients, respectively. These results suggest that TAVI can provide meaningful value to Japanese patients relative to SAVR, at a reasonable incremental cost for patients at low surgical risk and potentially resulting in cost-savings in patients at intermediate surgical risk.
Aortic Stenosis (AS) is the most common valvular heart disease in Japan, and, if left untreated, severe symptomatic AS (sSAS) is associated with a dramatic increase in mortality and morbidity. Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive treatment option for replacing the aortic valve in patients with sSAS and has been associated with similar or better outcomes compared to Surgical Aortic Valve Replacement (SAVR), which involves open-heart surgical replacement of the aortic valve. The objective of this study was to compare the costs and health outcomes associated with TAVI compared to SAVR in Japanese patients deemed low- or intermediate-risk for surgery. Despite the expanding use of TAVI in Japan, a cost-effectiveness analysis (CEA) does not exist that evaluates the economics of TAVI with the current generation SAPIEN 3 implant in patients with low- and intermediate-risk from a public perspective. Our study suggests that TAVI represents strong value for money among low- and intermediate-risk patients in Japan: compared to SAVR, TAVI is associated with better clinical outcomes and quality of life for patients, at a reasonable additional cost for low-risk patients and at a lower cost for intermediate-risk patients.
摘要：
■使用SAPIEN3（EdwardsLifesciences，Irvine,CA）从日本公共医疗保健支付者的角度来看，与低危和中危患者的外科主动脉瓣置换术（SAVR）进行了比较。
■开发了马尔可夫模型成本效益分析。从系统文献综述中提取临床和效用数据。成本输入是从医学数据视觉索赔数据库的分析中获得的，并进行了针对性的文献检索。使用敏感性分析评估结果的稳健性。进行了情景分析，以确定较低的平均年龄（77.5岁）的影响以及两种不同的长期死亡风险比（TAVI与SAVR：0.9-1.09）对两种风险水平人群的影响。这项分析是根据Core2Health在日本的成本效益评估指南进行的。
■在中危患者中，TAVI是一个主要的程序（TAVI具有更低的成本和更高的效率）。在低风险患者中，TAVI的增量成本效益比(ICER)为750,417日元/质量调整寿命年(QALY)，低于500万日元/QALY的成本效益门槛。TAVI的ICER对所有测试的灵敏度和情景分析都是稳健的。
■与SAVR相比，TAVI在中危和低危患者中占主导地位且具有成本效益，分别。这些结果表明，相对于SAVR，TAVI可以为日本患者提供有意义的价值，对于低手术风险的患者而言，这是合理的增量成本，并可能导致中等手术风险的患者节省成本。
主动脉瓣狭窄(AS)是日本最常见的心脏瓣膜病。and,如果不及时治疗，重度症状性AS(sSAS)与死亡率和发病率显著增加相关.经导管主动脉瓣植入术（TAVI）是一种微创治疗方案，用于替换sSAS患者的主动脉瓣，与外科主动脉瓣置换术（SAVR）相比，其结果相似或更好。这涉及主动脉瓣的心脏直视手术置换。这项研究的目的是比较TAVI与SAVR相关的成本和健康结果，日本患者被认为是低风险或中等风险的手术。尽管TAVI在日本的使用不断扩大，不存在成本-效果分析(CEA),该分析从公众的角度评估TAVI在低风险和中风险患者中的经济性。我们的研究表明，TAVI在日本的低风险和中危患者中具有很强的性价比：与SAVR相比，TAVI与患者更好的临床结果和生活质量相关，低风险患者的额外费用合理，中等风险患者的费用较低。
■开发了马尔可夫模型成本效益分析。从系统文献综述中提取临床和效用数据。成本输入是从医学数据视觉索赔数据库的分析中获得的，并进行了针对性的文献检索。使用敏感性分析评估结果的稳健性。进行了情景分析，以确定较低的平均年龄（77.5岁）的影响以及两种不同的长期死亡风险比（TAVI与SAVR：0.9-1.09）对两种风险水平人群的影响。这项分析是根据Core2Health在日本的成本效益评估指南进行的。
■在中危患者中，TAVI是一个主要的程序（TAVI具有更低的成本和更高的效率）。在低风险患者中，TAVI的增量成本效益比(ICER)为750,417日元/质量调整寿命年(QALY)，低于500万日元/QALY的成本效益门槛。TAVI的ICER对所有测试的灵敏度和情景分析都是稳健的。
■与SAVR相比，TAVI在中危和低危患者中占主导地位且具有成本效益，分别。这些结果表明，相对于SAVR，TAVI可以为日本患者提供有意义的价值，对于低手术风险的患者而言，这是合理的增量成本，并可能导致中等手术风险的患者节省成本。
主动脉瓣狭窄(AS)是日本最常见的心脏瓣膜病。and,如果不及时治疗，重度症状性AS(sSAS)与死亡率和发病率显著增加相关.经导管主动脉瓣植入术（TAVI）是一种微创治疗方案，用于替换sSAS患者的主动脉瓣，与外科主动脉瓣置换术（SAVR）相比，其结果相似或更好。这涉及主动脉瓣的心脏直视手术置换。这项研究的目的是比较TAVI与SAVR相关的成本和健康结果，日本患者被认为是低风险或中等风险的手术。尽管TAVI在日本的使用不断扩大，不存在成本-效果分析(CEA),该分析从公众的角度评估TAVI在低风险和中风险患者中的经济性。我们的研究表明，TAVI在日本的低风险和中危患者中具有很强的性价比：与SAVR相比，TAVI与患者更好的临床结果和生活质量相关，低风险患者的额外费用合理，中等风险患者的费用较低。
