Hu Shanlian, Zhang Yabing, He Jiangjiang, Du Lixia, Xu Mingfei, Xie Chunyan, Peng Ying, Wang Linan
School of Public Health, Fudan University, 138 Yi Xue Yuan Rd, Shanghai, 200032, People's Republic of China,
Appl Health Econ Health Policy. 2015 Aug;13 Suppl 1(Suppl 1):S13-20. doi: 10.1007/s40258-014-0150-5.
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.
本文旨在采用多标准决策分析(MCDA)方法,围绕对中国现行定价和报销政策的系统分析,为专利过期的原研药定义一种基于价值的定价和报销方法。药物价格政策审查与对中国药品采购数据库的定量分析相结合。通过对知名学术专家和行业利益相关者进行访谈,运用MCDA确定政策偏好。研究结果表明,中国现行价格政策包括基于成本的定价以及为专利过期的原研药设定最高零售价和溢价,而未来可能会采用参考定价。文献综述显示,原研药和仿制药的溶出曲线存在显著差异;因此,溶出曲线需要改进。市场数据分析表明,2002年至2011年期间,仿制药与专利过期的原研药的总体价格比约为0.54 - 0.59,平均价格差为40%。确定了十个差异化价值属性,并运用MCDA来测试三种定价政策情景的影响。在实施质量一致性监管的条件下,缩小高质量专利过期产品(包括原研药和仿制药)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年内到期;因此,定价将成为专利过期的原研药和仿制药替代品的一个重要问题。