CRECON Medical Assessment Inc, Tokyo, Japan.
Division of Cardiology, Cardiovascular Center, Saiseikai Kumamoto Hospital, Kumamoto, Japan.
Value Health Reg Issues. 2020 May;21:82-90. doi: 10.1016/j.vhri.2019.07.013. Epub 2019 Oct 25.
Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis.
This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan.
The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results.
The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY.
TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.
经导管主动脉瓣植入术(TAVI)是一种创新性且有效的治疗方法,适用于高手术风险(HR)和无法手术的症状性重度主动脉瓣狭窄患者。
本研究通过与日本厚生劳动省卫生、劳动和福利成本效益评估方法学指南保持一致,对经股动脉 TAVI(TF-TAVI)与外科主动脉瓣置换术(SAVR)进行成本效益分析。
从国家支付者的角度,采用终生马尔可夫模拟对使用 SAPIEN XT 的 TF-TAVI 的成本效益进行评估。比较对象为 HR 患者的 SAVR 和无法手术患者的标准治疗(SOC)。对 TF-TAVI 和比较器的临床证据进行了系统的文献回顾。TF-TAVI 的证据来自 SOURCE XT 登记处和日本上市后监测。由于没有直接或间接比较使用 SAPIEN XT 的 TF-TAVI 与比较器的文献,因此考虑到研究纳入标准和患者背景(例如年龄和手术风险评分)的相似性,从相关已发表的研究中选择了比较器数据。进行敏感性分析以验证结果的稳健性。
与 HR 患者的 SAVR 相比,TF-TAVI 的增量成本效益比为 ¥130 万/质量调整生命年(QALY)。与无法手术患者的 SOC 相比,TF-TAVI 的增量成本效益比为 ¥350 万/QALY。
使用 500 万日元/QALY 的阈值,TF-TAVI 与 HR 患者的 SAVR 相比具有成本效益,与无法手术患者的 SOC 相比也具有成本效益。