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澳大利亚、新西兰、韩国和新加坡的仿制药定价政策:专利到期及对阿托伐他汀价格的影响。

Pricing policies for generic medicines in Australia, New Zealand, the Republic of Korea and Singapore: patent expiry and influence on atorvastatin price.

作者信息

Roughead Elizabeth E, Kim Dong-Sook, Ong Benjamin, Kemp-Casey Anna

机构信息

Sansom Institute for Health Research, University of South Australia, Adelaide, Australia.

Pharmaceutical Policy Research Team, Research Centre, Health Insurance Review and Assessment Service, Seoul, Republic of Korea.

出版信息

WHO South East Asia J Public Health. 2018 Sep;7(2):99-106. doi: 10.4103/2224-3151.239421.

DOI:10.4103/2224-3151.239421
PMID:30136668
Abstract

BACKGROUND

Little is known about how the different policies available to promote use of generic medicines affect the price per unit supplied or sold. This study compares the influence of pricing policies for generic medicines on atorvastatin prices in Australia, New Zealand, the Republic of Korea and Singapore, after market entry of generic atorvastatin.

METHODS

The annual price of atorvastatin per defined daily dose supplied (price/DDD) was examined for each country from 2006 to 2015 (≥2 years before and ≥4 years after generic market entry). Prices were converted to international dollars and cumulative percentage price reductions were calculated for the first 4 years following generic entry.

RESULTS

Prior to market entry of generic atorvastatin, New Zealand had the lowest price ($0.10/DDD), and the Republic of Korea the highest ($2.89/DDD). The price/DDD fell immediately after generic entry in all countries except New Zealand, which already had low prices. The largest immediate decrease was observed in Singapore (46%, year 1). By the fourth year after generic entry, the price had fallen by 46-80% in all countries; however, large price differences between countries remained.

CONCLUSION

New Zealand's tendering system and use of preferred medicines resulted in very low atorvastatin prices well before patent expiry. Pricing policies in the other three countries were effective in reducing atorvastatin prices, with reductions of between 46% and 80% within 4 years of generic entry. Where tendering and use of preferred medicines were the mechanisms for atorvastatin procurement (New Zealand), prices were lowest before and after generic entry. Mandatory price cuts, combined with price-disclosure policies (Australia), produced similar relative price reductions to tendering systems (New Zealand, Singapore) at 4 years. By comparison, mandatory price cuts upon generic entry as the sole measure, while initially effective, were associated with the smallest relative reduction in price after 4 years (Republic of Korea).

摘要

背景

对于促进仿制药使用的不同政策如何影响供应或销售的单位价格,人们了解甚少。本研究比较了仿制药阿托伐他汀在澳大利亚、新西兰、韩国和新加坡上市后,仿制药定价政策对阿托伐他汀价格的影响。

方法

对2006年至2015年期间每个国家每规定日剂量(price/DDD)的阿托伐他汀年价格进行了研究(仿制药上市前至少2年和上市后至少4年)。价格换算为国际美元,并计算仿制药上市后头4年的累计降价百分比。

结果

在仿制药阿托伐他汀上市前,新西兰价格最低(0.10美元/DDD),韩国最高(2.89美元/DDD)。除价格本就较低的新西兰外,所有国家仿制药上市后价格/DDD立即下降。新加坡降幅最大(第1年为46%)。到仿制药上市后第4年,所有国家价格均下降了46%至80%;然而,各国之间仍存在较大价格差异。

结论

新西兰的招标制度和优先药品的使用在专利到期前很久就使阿托伐他汀价格非常低。其他三个国家的定价政策在降低阿托伐他汀价格方面有效,仿制药上市后4年内降价幅度在46%至80%之间。在以招标和优先药品使用作为阿托伐他汀采购机制的地方(新西兰),仿制药上市前后价格最低。强制降价与价格披露政策相结合(澳大利亚),在4年时产生了与招标制度(新西兰、新加坡)类似的相对价格降幅。相比之下,仅以仿制药上市时强制降价作为唯一措施,虽然最初有效,但在4年后价格相对降幅最小(韩国)。

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