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A Case Study of Pharmaceutical Pricing in China: Setting the Price for Off-Patent Originators

机译:中国药品定价的案例研究:为非专利授权者定价

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摘要

This article aims to define a value-based approach to pricing and reimbursement for off-patent originators using a multiple criteria decision analysis (MCDA) approach centered on a systematic analysis of current pricing and reimbursement policies in China. A drug price policy review was combined with a quantitative analysis of China’s drug purchasing database. Policy preferences were identified through a MCDA performed by interviewing well-known academic experts and industry stakeholders. The study findings indicate that the current Chinese price policy includes cost-based pricing and the establishment of maximum retail prices and premiums for off-patent originators, whereas reference pricing may be adopted in the future. The literature review revealed significant differences in the dissolution profiles between originators and generics; therefore, dissolution profiles need to be improved. Market data analysis showed that the overall price ratio of generics and off-patent originators was around 0.54–0.59 in 2002–2011, with a 40 % price difference, on average. Ten differentiating value attributes were identified and MCDA was applied to test the impact of three pricing policy scenarios. With the condition of implementing quality consistency regulations and controls, a reduction in the price gap between high-quality off-patent products (including originator and generics) seemed to be the preferred policy. Patents of many drugs will expire within the next 10 years; thus, pricing will be an issue of importance for off-patent originators and generic alternatives.
机译:本文旨在使用多标准决策分析(MCDA)方法,为基于专利的发起人定价和报销定义一种基于价值的方法,该方法以对中国当前定价和报销政策的系统分析为中心。药品价格政策审查与对中国药品购买数据库的定量分析相结合。通过采访知名学术专家和行业利益相关者进行的MCDA来确定政策偏好。研究结果表明,当前的中国价格政策包括基于成本的定价以及为专利非专利发起人确定的最高零售价格和溢价,而未来可能会采用参考定价。文献综述表明,原始药品和仿制药之间的溶出曲线存在显着差异。因此,需要改善溶出度。市场数据分析表明,在2002-2011年间,仿制药和非专利原研药的总体价格比率约为0.54-0.59,平均价格差异为40%。确定了十个区分价值属性,并将MCDA应用于测试三种定价策略方案的影响。在实施质量一致性法规和控制的条件下,缩小高质量非专利产品(包括原研药和非专利药)之间的价格差距似乎是首选政策。许多药物的专利将在未来10年内失效;因此,价格将是非专利发起人和通用替代品重要的问题。

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