欧洲生物类似药市场准入政策解读与思考  

Insight into market access policies of biosimilars in Europe

作　　者：徐巍巍 吴晶[3] XU Wei-wei;WU Jing

机构地区：[1]Fresenius Kabi Swiss Bio Sim,1260 Nyon,Switzerland [2]中国天津大学药学院医药政策与经济研究中心,天津300072 [3]中国天津大学药物科学与技术学院,天津300072

出　　处：《中国药物经济学》2018年第11期16-21,共6页China Journal of Pharmaceutical Economics

摘　　要：生物类似药高度类似于其原研药品。由于相对于原研药品的价格优势,欧洲各国付费方期待生物类似药能够缓解卫生系统面临的巨大财政压力。本文浅析生物类似药在欧洲五国(英国、德国、法国、意大利和西班牙)的上市许可政策以及药物经济学证据对市场准入与定价政策的支持,希望对国内的相关政策制定有所启发。生物类似药的上市许可一般通过欧洲药品管理局进行。欧洲药品管理局要求生物类似药的生产厂家通过全面的一致性试验证明生物类似药和原研药品的"相似性"。在获得了上市许可批准之后,生物类似药的定价以及是否进入医疗保险目录由欧盟各个国家独立决定。对于生物类似药,欧洲五国有三大类市场准入和定价相关政策,包括价格控制,如法国、意大利和西班牙的(半)强制价格干预,德国和英国的厂商自由定价;需方教育,如德国和英国大力推动对需方(医生、患者)的教育培训;以及需方财政激励,如付费方对医生或者医院实行财政激励,鼓励其广泛使用生物类似药。生物类似药的性质决定了医生和患者对其临床疗效和安全性认识上存在一定程度的不确定性。因此,推动生物类似药广泛使用的关键在于解决不确定性带来的顾虑。德国的例子在一定程度上说明相比价格控制,针对需方的政策,包括需方教育配合需方财政激励,会取得事半功倍的效果。Biosimilars are highly similar to their reference medications.Payers across European countries hold high expectations on biosimilars to relief the huge financial burden on healthcare systems based on an expected price advantage of biosimilars vs.their reference medications.This study analyses the market access policies and the use of pharmacoeconomic evidence in market access and pricing of biosimilars in the EU5 countries(including UK,Germany,France,Italy and Spain).The objective of this study is to inspire policy makers in China regarding relevant biosimilar policies.In Europe,market authorization of biosimilars is generally granted by the European Medicines Agency(EMA),based on comprehensive comparability studies to demonstrate the similarity between biosimilars and their reference medications.Upon the EMA approval,the reimbursement and pricing of biosimilars are decided independently by each member states in the European Union.There are three categories of market access and pricing policies for biosimilars in the EU5 countries:including price control,e.g.(semi)mandatory pricing rules in France,Italy and Spain vs.free-pricing in Germany and UK;demand side education,e.g.proactive education and training towards the demand side(physicians and patients)in Germany and UK;and demand-side financial incentives,e.g.payers set financial incentive mechanisms to hospitals or physicians in order to encourage the use the biosimilars.The nature of biosimilars leads to a certain extent of uncertainties in clinical effectiveness and safety and hence some concerns from physicians and patients.The case study in Germany showed that policies targeting at the demand-side,including education and financial incentives are more efficiency compared to pure price control.

关 键 词：生物类似药 市场准入 药物经济学 定价 欧洲 

分 类 号：R951[医药卫生—药学]