Luo Zhenhuan, Gyawali Bishal, Han Sheng, Shi Luwen, Guan Xiaodong, Wagner Anita Katharina
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Department of Oncology, Department of Public Health Sciences and Division of Cancer Care and Epidemiology, Queen's University, Kingston, Canada.
Semin Oncol. 2021 Apr;48(2):141-144. doi: 10.1053/j.seminoncol.2021.03.001. Epub 2021 Apr 6.
Rapid growth in pharmaceutical expenditures and high prices have greatly hampered access to medicines, especially targeted anticancer medicines. Confronted with such difficulties, the Chinese government has put more effort into supporting local research and development of cancer medicines, resulting in locally developed me-too drugs. Since 2016, the government has implemented a central reimbursement-linked drug price negotiation policy aimed at reducing the prices of expensive medicines. Locally developed me-too drugs marketed at lower prices may inject price competition and help negotiate reduced prices of similar internationally-developed products. As an example, we selected 3 tyrosine kinase inhibitors (TKIs) developed for the therapy of advanced non-small cell lung cancer harboring mutations in the epidermal growth factor receptor (EGFR). Descriptive analysis was applied to data from the Chinese Medical Economic Information database to describe the impact on the price and utilization of three TKIs after the introduction of icotinib, a locally developed me-too TKI and two national negotiations regarding the price of EGFR-TKIs in China. After two national negotiations, the daily costs of all three EGFR-TKIs were reduced to around $30. From the first quarter of 2013 to the second quarter of 2016, the market share of the purchasing volume of icotinib, China's locally developed TKI, increased from 13% to 40%, while the market shares of two internationally developed TKIs decreased from 35% to 15% and from 52% to 45%, for erlotinib and gefitinib, respectively. The prices of EGFR-TKIs decreased and China's locally developed TKI accounted for a considerable proportion of market share. Locally developed me-too drugs aid price negotiation by injecting price competition and helping negotiate reduced prices of similar internationally-developed products. Through efforts to develop me-too drugs, combined with national drug price negotiation and reimbursement policies, developing countries might improve access to more affordable targeted cancer therapies.
药品支出的快速增长和高昂价格极大地阻碍了药品的可及性，尤其是靶向抗癌药物。面对这些困难，中国政府加大了支持本土抗癌药物研发的力度，催生了本土研发的仿制药。自2016年以来，政府实施了与医保报销挂钩的药品价格谈判政策，旨在降低高价药品的价格。以较低价格上市的本土仿制药可能会引发价格竞争，并有助于协商降低类似国际研发产品的价格。例如，我们选择了3种用于治疗表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌的酪氨酸激酶抑制剂（TKIs）。对来自中国医药经济信息数据库的数据进行描述性分析，以描述本土研发的仿制药埃克替尼以及中国两次关于EGFR-TKIs价格的国家谈判对三种TKIs价格和使用情况的影响。经过两次国家谈判，所有三种EGFR-TKIs的每日费用都降至约30美元。从2013年第一季度到2016年第二季度，中国本土研发的TKI埃克替尼的采购量市场份额从13%增至40%，而两种国际研发的TKIs，即厄洛替尼和吉非替尼的市场份额分别从35%降至15%、从52%降至45%。EGFR-TKIs的价格下降，且中国本土研发的TKI占据了相当大的市场份额。本土研发的仿制药通过引发价格竞争和帮助协商降低类似国际研发产品的价格来助力价格谈判。通过努力研发仿制药，结合国家药品价格谈判和报销政策，发展中国家或许能够改善获得更可负担的靶向癌症治疗药物的可及性。
