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英国国家卫生与临床优化研究所(NICE)是否影响英国仿制药的采用和普及?

Does NICE influence the adoption and uptake of generics in the UK?

机构信息

Department of Economics, City, University of London, London, UK.

Department of Health Policy, London School of Economics and Political Science, London, UK.

出版信息

Eur J Health Econ. 2021 Mar;22(2):229-242. doi: 10.1007/s10198-020-01245-1. Epub 2020 Dec 7.

Abstract

The aim of this paper is to examine generic competition in the UK, with a special focus on the role of Health Technology Assessment (HTA) on generic market entry and diffusion. In the UK, where no direct price regulation on pharmaceuticals exists, HTA has a leading role for recommending the use of medicines providing a non-regulatory aspect that may influence the dynamics in the generic market. The paper focuses on the role of Technology Appraisals issued by the National Institute for Health and Care Excellence (NICE). We follow a two-step approach. First, we examine the probability of generic entry. Second, conditional on generic entry, we examine the determinants of generic market share. We use data from IQVIA British Pharmaceutical Index (BPI) for the primary care market for 60 products that lost patent between 2003 and 2012. Our results suggest that market size remains one of the main drivers of generic entry. After controlling for market size, intermolecular substitution and difficulty of manufacturing increase the likelihood of generic entry. After generic entry, our estimates suggest that generic market share is highly state dependent. Our findings also suggest that while NICE recommendations do influence generic uptake, there is only marginal evidence they affect generic entry.

摘要

本文旨在考察英国的仿制药竞争,特别关注卫生技术评估(HTA)在仿制药市场准入和扩散中的作用。在英国,药品没有直接的价格管制,HTA 在推荐使用药品方面发挥着主导作用,提供了一种可能影响仿制药市场动态的非监管方面。本文重点关注英国国家卫生与保健优化研究所(NICE)发布的技术评估的作用。我们采用两步法。首先,我们考察仿制药进入的概率。其次,在仿制药进入的情况下,我们考察仿制药市场份额的决定因素。我们使用 IQVIA 英国制药指数(BPI)的数据,该数据来自 2003 年至 2012 年间失去专利的 60 种产品的初级保健市场。我们的研究结果表明,市场规模仍然是仿制药进入的主要驱动因素之一。在控制了市场规模之后,分子间替代和制造难度增加了仿制药进入的可能性。在仿制药进入之后,我们的估计表明,仿制药市场份额高度依赖于国家。我们的研究结果还表明,尽管 NICE 的建议确实影响了仿制药的采用,但只有边际证据表明它们影响了仿制药的进入。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a250/7881963/5d6ac303d5ae/10198_2020_1245_Fig1_HTML.jpg

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