Cost-effectiveness evaluation for pricing medicines and devices: A new value-based price adjustment system in Japan
Cost-effectiveness evaluation for pricing medicines and devices: A new value-based price adjustment system in Japan
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DOI：
10.1017/s0266462320000264
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发表时间：
2020-06-01
影响因子：
3.2
通讯作者：
Shiroiwa, Takeru
中科院分区：
文献类型：
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作者：
Shiroiwa, Takeru
目标.日本在2019年4月试行了新的药品和医疗器械定价成本效益评估体系。本研究描述了2016年4月至2019年3月期间就新引入的系统进行的讨论。本报告利用政府公开文件、与利益相关者的讨论以及垂京委员会的会议记录，阐述了以下问题：（i）试行的结果;（ii）新引进系统的概况。在试行期间，对13种产品进行了评估和价格调整。新系统的过程-将于2019财年实施-在国民健康保险列出目标产品后大约需要15-18个月才能完成。目标产品的选择主要基于销售量、创新程度（溢价）以及定价理由的披露。首先，制造商提交成本效益数据，然后由健康成果研究和经济评估中心（C2 H）与学术界合作进行审查。在关于产品列入的决策过程中，不考虑成本效益评价的结果。价格调整机制与价值定价机制相似，因此，新的价格调整机制可以被视为价值定价机制。成本效益评估有助于促进医疗保健系统的技术创新和可持续性。我们需要创造更大的能力来加强这一学术审查制度。
Objectives. In Japan, a new cost-effectiveness evaluation system for medicine and medical device pricing was employed in April 2019 after a trial implementation. This study describes the discussions held from April 2016 to March 2019 concerning the newly introduced system.Methods. Using published government documents, discussions with stakeholders, and the minutes of the Chuikyo committee meetings, the following issues are addressed: (i) the results of the trial implementation and (ii) an overview of the newly introduced system.Results. During the trial implementation, thirteen products were evaluated and their prices adjusted. The process of the new system-which was to be implemented in FY 2019-takes about 15-18 months to complete after listing of the target products by the National Health Insurance. The target products are selected principally based on sales volume, degree of innovation (premium), and disclosure of rationale for price setting. First, a manufacturer submits the cost-effectiveness data, which is then reviewed by the Center for Outcomes Research and Economic Evaluation for Health (C2H) in collaboration with academics. The results of the cost-effectiveness evaluation are not considered during the decision-making process concerning the product's listing. The price adjustment system is similar to value-based pricing (VBP); hence, the new system can be considered as VBP adjustment.Conclusion. Cost-effectiveness evaluation can help promote both technological innovation and sustainability of the healthcare system. We need to create a greater capacity for enhancing this academic review system.