Division of Infectious Disease and International Medicine, Department of Internal Medicine.
Clinical and Translational Science Institute, University of Minnesota, Minneapolis.
Clin Infect Dis. 2017 Nov 13;65(11):1848-1852. doi: 10.1093/cid/cix634.
In recent years, the price of many older generic drugs, including numerous antibiotics, has increased substantially. We sought to analyze recent price changes and extent of generic competition within a cohort of commonly prescribed off-patent oral antibiotics.
We extracted oral antibiotics recommended for common outpatient conditions in the Infectious Diseases Society of America Practice Guidelines. We determined all US Food and Drug Administration-approved manufacturers for each formulation and strength in 2013 and 2016 and the yearly national average drug acquisition cost (NADAC) price between 2013 and 2016. Wilcoxon signed rank test was used to compare changes in drug prices and number of manufacturers from 2013 to 2016. Spearman correlation coefficient was used to assess the association between drug prices and number of manufacturers.
Twenty-two antibiotics (81 formulations and strengths) were analyzed. There was no change in the median NADAC price or the number of manufacturers between 2013 and 2016. However, 11 (14%) formulations increased in price by 90% or more, and 13 (16%) had 2 or fewer manufacturers during all 4 years. Antibiotic prices were negatively associated with the number of available manufacturers.
While prices and the number of manufacturers for common oral antibiotics were overall stable between 2013 and 2016, reduced manufacturer competition was associated with increased prices. A subset of antibiotics exhibited substantial price increases, and most, but not all, had limited manufacturer competition. Policy solutions are needed to ensure availability of low-cost, essential generic antibiotics.
近年来，包括许多抗生素在内的许多旧专利通用药物的价格大幅上涨。我们试图分析一组常用的非专利口服抗生素中最近的价格变化和通用竞争程度。
我们提取了美国传染病学会实践指南中推荐的用于常见门诊情况的口服抗生素。我们确定了每种配方和强度在 2013 年和 2016 年的所有美国食品和药物管理局批准的制造商，以及 2013 年至 2016 年之间的每年国家平均药物收购成本（NADAC）价格。Wilcoxon 符号秩检验用于比较 2013 年至 2016 年药物价格和制造商数量的变化。Spearman 相关系数用于评估药物价格与制造商数量之间的关联。
分析了 22 种抗生素（81 种配方和强度）。2013 年至 2016 年间，NADAC 价格中位数或制造商数量没有变化。然而，有 11 种（14%）配方的价格上涨了 90%或更多，有 13 种（16%）配方在所有 4 年中只有 2 个或更少的制造商。抗生素价格与可用制造商数量呈负相关。
尽管 2013 年至 2016 年间常用口服抗生素的价格和制造商数量总体稳定，但制造商竞争的减少与价格上涨有关。一组抗生素的价格大幅上涨，大多数（但不是全部）抗生素的制造商竞争有限。需要政策解决方案来确保低价、基本的通用抗生素的供应。
