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中国药科大学国际医药商学院,南京 211198
Received:26 September 2023,
Revised:2024-03-17,
Accepted:19 March 2024,
Published:30 April 2024
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王琳宁,杨盟雨,虞杰,等.日本成本-效用评估制度对我国医保目录药品准入定价的启示[J].中国药房,2024,35(08):901-905.
WANG Linning,YANG Mengyu,YU Jie,et al.Insights from Japan’s cost-effectiveness analysis policy on pricing for China’s NRDL access[J].ZHONGGUO YAOFANG,2024,35(08):901-905.
王琳宁,杨盟雨,虞杰,等.日本成本-效用评估制度对我国医保目录药品准入定价的启示[J].中国药房,2024,35(08):901-905. DOI: 10.6039/j.issn.1001-0408.2024.08.01.
WANG Linning,YANG Mengyu,YU Jie,et al.Insights from Japan’s cost-effectiveness analysis policy on pricing for China’s NRDL access[J].ZHONGGUO YAOFANG,2024,35(08):901-905. DOI: 10.6039/j.issn.1001-0408.2024.08.01.
日本于2019年开始正式对药品施行成本-效用评估政策,实现了不同品种的价格定量化调整。在评估品种上,日本采用分级分类手段遴选预计年销售额较大的品种,并根据预先设定的增量成本-效果比(ICER)阈值对现有价格构成中的溢价部分和利润部分进行调整,从而解决了由主观差异导致的调整标准和幅度不一致的问题;同时,该政策对部分药品进行了特殊考量,给予评估豁免或提高ICER阈值的激励措施。在价格调整机制上,日本针对药品价格加算部分和营业利润部分,结合阶梯式ICER阈值和量化公式,构建了有升有降的价格调整机制。我国在医保目录准入环节,仍存在部分药品价格形成的量化机制不够明确、价格修正措施不完善、沟通环节滞后等问题。建议我国可在医保准入阶段提高特殊人群用药的ICER阈值,量化调增、调减的标准和幅度,对提交高质量疗效证据的企业给予价格激励,前置企业沟通环节,就降价幅度过大的准入品种探索建立价格兜底机制,以进一步提升我国医保目录准入过程中药品定价的科学性和公平性。
The cost-effectiveness analysis policy for drugs was institutionalized in Japan since 2019, realizing quantitative adjustment of price across varieties. A hierarchical categorization approach was adopted to select medicines with high expected annual sales. For selected medicines, adjustments were made to the premium and profit components within the existing price structure based on a pre-defined incremental cost-effectiveness ratio (ICER) threshold, effectively resolving the issue of inconsistent criteria and magnitudes caused by subjective judgment. Meanwhile, incentive measures like evaluation exemption or threshold enhancement were granted for specific medicines. Besides, a price adjustment mechanism, which was allowed for upward and downward adjustments, involving tiered ICER threshold and quantified formulas, had been established for the premium and profit components of drug price. In China’s National Reimbursement Drug List (NRDL) access, certain issues remained to be addressed: insufficient clarity in the quantitative mechanism of price formation, incomplete price adjustment measures, and lagging in the communication channels. It is recommended that the following measures could be referred to when further improving the scientificity and fairness of drug pricing during China’s NRDL access, such as enhancing the ICER threshold for medicines catering to special populations, quantifying criteria and extents for price adjustment, granting preferential pricing policies to pharmaceutical companies that present high-quality evidence of effectiveness, preceding communication channels with pharmaceutical companies, as well as exploring a price floor mechanism for the drugs with excessive price reduction.
LIU G , WU E Q , AHN J , et al . The development of health technology assessment in Asia:current status and future trends [J ] . Value Health Reg Issues , 2020 , 21 : 39 - 44 .
厚生労働省 . 令和6年度薬価改定について⑪ [EB/OL ] .( 2023-11-21 )[ 2024-02-02 ] . https://www.mhlw.go.jp/content/12404000/001169881.pdf https://www.mhlw.go.jp/content/12404000/001169881.pdf .
Ministry of Health , Labour and Welfare . 2024 NHI price revision:11 [EB/OL ] .( 2023-11-21 )[ 2024-02-02 ] . https://www.mhlw.go.jp/content/12404000/001169881.pdf https://www.mhlw.go.jp/content/12404000/001169881.pdf .
厚生労働省 . 令和6年度薬価改定について② [EB/OL ] .( 2023-07-11 )[ 2024-02-02 ] . https://www.mhlw.go.jp/content/12404000/001120014.pdf https://www.mhlw.go.jp/content/12404000/001120014.pdf .
Ministry of Health , Labour and Welfare . 2024 NHI price revision:2 [EB/OL ] .( 2023-07-11 )[ 2023-08-13 ] . https://www.mhlw.go.jp/content/12404000/001120014.pdf https://www.mhlw.go.jp/content/12404000/001120014.pdf .
HASEGAWA M , KOMOTO S , SHIROIWA T , et al . Formal implementation of cost-effectiveness evaluations in Japan:a unique health technology assessment system [J ] . Value Health , 2020 , 23 ( 1 ): 43 - 51 .
SHIROIWA T . Cost-effectiveness evaluation for pricing medicines and devices:a new value-based price adjustment system in Japan [J ] . Int J Technol Assess Health Care , 2020 , 36 ( 3 ): 270 - 276 .
SHIROIWA T , FUKUDA T , IKEDA S , et al . New decision-making processes for the pricing of health technologies in Japan:the FY 2016/2017 pilot phase for the introduction of economic evaluations [J ] . Health Policy , 2017 , 121 ( 8 ): 836 - 841 .
FUKUDA T , SHIROIWA T . Cost effectiveness evaluation of health care technologies in Japan:new HTA system and the role of C2H [J ] . J Natl Inst Public Health , 2021 , 70 : 22 - 27 .
KAMAE I , THWAITES R , HAMADA A , et al . Health technology assessment in Japan:a work in progress [J ] . J Med Econ , 2020 , 23 ( 4 ): 317 - 322 .
厚生労働省 . 令和4年度診療報酬改定の概要費用対効果評価制度 [EB/OL ] .( 2022-03-04 )[ 2024-02-02 ] . https://www.mhlw.go.jp/content/12400000/000906933.pdf https://www.mhlw.go.jp/content/12400000/000906933.pdf .
Ministry of Health , Labour and Welfare . Overview of the 2022 revision of medical fees:cost-effectiveness evalu-ation system [EB/OL ] .( 2022-03-04 )[ 2024-02-02 ] . https://www.mhlw.go.jp/content/12400000/000906933.pdf https://www.mhlw.go.jp/content/12400000/000906933.pdf .
张宸 , 凡馨 , 金秋晨 , 等 . 日本儿童药定价及价格激励政策对我国的启示 [J ] . 中国药房 , 2021 , 32 ( 23 ): 2822 - 2827 .
ZHANG C , FAN X , JIN Q C , et al . Pediatric drug pricing and price incentive policy in Japan and its enlightenment to China [J ] . China Pharm , 2021 , 32 ( 23 ): 2822 - 2827 .
马旭锋 , 颜建周 , 邵蓉 . 创新药品医保谈判准入制度中申报材料和证据的标准化研究 [J ] . 中国新药杂志 , 2021 , 30 ( 15 ): 1361 - 1366 .
MA X F , YAN J Z , SHAO R . Standardization of application materials and evidence in the negotiation access system of innovative medicines and medical insurance [J ] . Chin J N Drugs , 2021 , 30 ( 15 ): 1361 - 1366 .
李鑫垚 , 高杰 , 李元通 , 等 . 简易续约规则对谈判药品价格和持续供应的影响:现象及可行性方案探究 [J ] . 中国医疗保险 , 2024 ( 2 ): 60 - 71 .
LI X Y , GAO J , LI Y T , et al . Impact of the simplified renewal rules on negotiated drug prices and continuous supply:phenomenon and feasible solutions [J ] . China Health Insur , 2024 ( 2 ): 60 - 71 .
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