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澳大利亚的仿制药价格与政策:有改进空间吗?与英国的比较分析。

Generic drug prices and policy in Australia: room for improvement? a comparative analysis with England.

作者信息

Mansfield Sarah J

机构信息

Department of General Practice, Deakin University, 2-18 Colac Road, Belmont, Vic. 3216, Australia. Email:

出版信息

Aust Health Rev. 2014 Feb;38(1):6-15. doi: 10.1071/AH12009.

Abstract

OBJECTIVE

To assess the degree to which reimbursement prices in Australia and England differ for a range of generic drugs, and to analyse the supply- and demand-side factors that may contribute to these differences.

METHODS

Australian and English reimbursement prices were compared for a range of generic drugs using pricing information obtained from government websites. Next, a literature review was conducted to identify supply- and demand-side factors that could affect generic prices in Australia and England. Various search topics were identified addressing potential supply-side (e.g. market approval, intellectual property protection of patented drugs, generic pricing policy, market size, generic supply chain and discounting practices) and demand-side (consumers, prescribers and pharmacists) factors. Related terms were searched in academic databases, official government websites, national statistical databases and internet search engines.

RESULTS

Analysis of drug reimbursement prices for 15 generic molecules (representing 45 different drug presentations) demonstrated that Australian prices were on average over 7-fold higher than in England. Significant supply-side differences included aspects of pricing policy, the relative size of the generics markets and the use of clawback policies. Major differences in demand-side policies related to generic prescribing, pharmacist substitution and consumer incentives.

CONCLUSIONS

Despite recent reforms, the Australian Government continues to pay higher prices than its English counterpart for many generic medications. The results suggest that particular policy areas may benefit from review in Australia, including the length of the price-setting process, the frequency of subsequent price adjustments, the extent of price competition between originators and generics, medical professionals' knowledge about generic medicines and incentives for generic prescribing. WHAT IS KNOWN ABOUT THE TOPIC? Prices of generic drugs have been the subject of much scrutiny over recent years. From 2005 to 2010 the Australian Government responded to observations that Pharmaceutical Benefits Scheme prices for many generics were higher than in numerous comparable countries by instituting several reforms aimed at reducing the prices of generics. Despite this, several studies have demonstrated that prices for generic statins (one class of cholesterol-lowering drug) are higher in Australia compared with England and many other developed countries, and prices of numerous other generics remain higher than in the USA and New Zealand. Recently there has been increasing interest in why these differences exist. WHAT DOES THIS PAPER ADD? By including a much larger range of commonly used and costly generic drugs, this paper builds significantly on the limited previous investigations of generic drug prices in Australia and England. Additionally, this is the first comprehensive investigation of multiple supply- and, in particular, demand-side factors that may explain any price differences between these countries. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners may contribute to the higher prices of generic medications in Australia compared with England through relatively low rates of generic prescribing. There are also significant implications for health policy makers, as this paper demonstrates that if Australia achieved the same prices as England for many generic drugs there could be substantial savings for the Pharmaceutical Benefits Scheme.

摘要

目的

评估澳大利亚和英国一系列仿制药的报销价格差异程度,并分析可能导致这些差异的供应方和需求方因素。

方法

利用从政府网站获取的定价信息,比较澳大利亚和英国一系列仿制药的报销价格。接下来,进行文献综述,以确定可能影响澳大利亚和英国仿制药价格的供应方和需求方因素。确定了各种搜索主题,涉及潜在的供应方因素(如市场批准、专利药品的知识产权保护、仿制药定价政策、市场规模、仿制药供应链和折扣做法)和需求方因素(消费者、开处方者和药剂师)。在学术数据库、官方政府网站、国家统计数据库和互联网搜索引擎中搜索相关术语。

结果

对15种仿制药分子(代表45种不同药品剂型)的药品报销价格分析表明,澳大利亚的价格平均比英国高出7倍多。供应方的显著差异包括定价政策方面、仿制药市场的相对规模以及回扣政策的使用。需求方政策在仿制药处方、药剂师替代和消费者激励方面存在重大差异。

结论

尽管最近进行了改革,但澳大利亚政府在许多仿制药上支付的价格仍高于英国。结果表明,澳大利亚的特定政策领域可能需要进行审查,包括定价过程的时长、后续价格调整的频率、原研药和仿制药之间的价格竞争程度、医疗专业人员对仿制药的了解以及仿制药处方的激励措施。关于该主题已知的情况是什么?近年来,仿制药价格一直备受 scrutiny。2005年至2010年期间,澳大利亚政府针对许多仿制药的药品福利计划价格高于众多可比国家的情况,进行了多项旨在降低仿制药价格的改革。尽管如此,多项研究表明,澳大利亚的仿制药他汀类药物(一类降胆固醇药物)价格高于英国和许多其他发达国家,许多其他仿制药的价格也高于美国和新西兰。最近,人们对这些差异为何存在的兴趣与日俱增。本文补充了什么?通过纳入范围更广的常用且昂贵的仿制药,本文在澳大利亚和英国仿制药价格此前有限的调查基础上有了显著拓展。此外,这是对可能解释这些国家之间价格差异的多个供应方因素,尤其是需求方因素的首次全面调查。对从业者有何影响?与英国相比,澳大利亚仿制药价格较高,从业者可能因仿制药处方率相对较低而对此有所影响。这对卫生政策制定者也有重大影响,因为本文表明,如果澳大利亚许多仿制药的价格与英国相同,药品福利计划可能会节省大量资金。

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