Columbia University, New York, New York, USA.
National Bureau of Economic Research, Cambridge, Massachusetts, USA.
Health Econ. 2021 Aug;30(8):1910-1932. doi: 10.1002/hec.4283. Epub 2021 May 13.
There are several types of pharmaceutical competition. In addition to competition among producers of the same chemical substance ("within-substance competition"), there may be competition among producers of different chemical substances in the same chemical subgroup ("between-substance competition"). There have been numerous econometric studies of the effect of within-substance competition on drug prices, but empirical evidence about the effect of between-substance competition is far more limited. The primary objective of this study is to assess the impact of the entry of new drugs in a drug's therapeutic class on branded drug prices, generic drug prices, and the generic market share, using publicly-available US data for the period 1997-2017. Two methods are used to estimate the effects of between-substance and within-substance competition on those variables. The first method is standard 2-way fixed effects estimation based on aggregate data. The second method, based on micro data, is estimation using the DID_MULTIPLEGT procedure developed by de Chaisemartin et al. (2021), which does not rely on, and allows us to test for, "parallel trends." Between-substance competition does not appear to have any effect on brand-name drug prices, although our inability to fully account for rebates may bias the estimates towards zero. (There is also little evidence for an effect of within-substance competition on brand-name drug prices.) However, between-substance competition has a significant negative effect on generic drug prices. We estimate that the 1985-2005 increase in the number of substances ever registered in a drug's ATC4 chemical subgroup reduced the 2017 price of generic drugs by 42%. (The ratio of the generic-price reduction attributable to rising between-substance competition to the generic-price reduction attributable to rising within-substance competition also happens to be 42%.) A striking finding is that the entry of imitators has no effect on the prices of brand-name drugs, but the entry of innovators has a significant negative effect on the prices of generic drugs in the same ATC4 chemical subgroup. In addition, between-substance competition has a significant positive effect on the generic market share: the 1985-2005 increase in the number of substances ever registered in a drug's ATC4 chemical subgroup increased the 2017 generic market share by 15.0 percentage points. Due to its effects on generic drug prices and the generic market share, the 1985-2005 increase in between-substance competition reduced the average 2017 price of drugs that were already sold in 1997 by 35%. We estimate that 36% of 2017 expenditure on drugs that were first registered during 1986-2005 was offset by reduced 2017 expenditure on drugs that were sold in both 1997 and 2017.
有几种类型的药物竞争。除了同一化学物质的生产者之间的竞争(“同一物质内竞争”)之外,同一化学亚组中的不同化学物质的生产者之间也可能存在竞争(“不同物质间竞争”)。已经有许多关于同一物质内竞争对药品价格影响的计量经济学研究,但关于不同物质间竞争影响的经验证据则要少得多。本研究的主要目的是使用 1997 年至 2017 年期间美国公开数据,评估新进入药物治疗类别的药物对品牌药物价格、仿制药价格和仿制药市场份额的影响。两种方法用于估计不同物质间和同一物质内竞争对这些变量的影响。第一种方法是基于汇总数据的标准双向固定效应估计。第二种方法基于微观数据,使用 de Chaisemartin 等人(2021 年)开发的 DID_MULTIPLEGT 程序进行估计,该方法不依赖于并允许我们测试“平行趋势”。不同物质间竞争似乎对品牌药价格没有任何影响,尽管我们无法充分考虑回扣可能会使估计值偏向零。(同一物质内竞争对品牌药价格也几乎没有影响。)然而,不同物质间竞争对仿制药价格有显著的负向影响。我们估计,1985 年至 2005 年间,在药物的 ATC4 化学亚组中注册的物质数量增加,导致 2017 年仿制药价格降低了 42%。(归因于不同物质间竞争导致的仿制药价格降低与归因于同一物质内竞争导致的仿制药价格降低的比例也恰好为 42%。)一个惊人的发现是,仿制药的进入对品牌药价格没有影响,但创新药的进入对同一 ATC4 化学亚组中的仿制药价格有显著的负向影响。此外,不同物质间竞争对仿制药市场份额有显著的正向影响:1985 年至 2005 年间,在药物的 ATC4 化学亚组中注册的物质数量增加,使 2017 年仿制药市场份额增加了 15.0 个百分点。由于不同物质间竞争对仿制药价格和仿制药市场份额的影响,1985 年至 2005 年间不同物质间竞争的增加导致 1997 年已销售药物的平均 2017 年价格降低了 35%。我们估计,在 2017 年支出中,有 36%用于抵消在 1986 年至 2005 年期间首次注册的药物的 2017 年支出,这些药物在 1997 年和 2017 年均有销售。