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美国抗真菌药物价格上涨,2000-2019 年。

Antifungal drug price increases in the United States, 2000-2019.

机构信息

Division of Infectious Diseases and International Medicine, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.

Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas, USA.

出版信息

Mycoses. 2022 Sep;65(9):859-865. doi: 10.1111/myc.13486. Epub 2022 Jul 18.

Abstract

BACKGROUND

Antifungal drugs treat a variety of conditions, ranging from localised dermatologic disease to life-threatening systemic infections. Some common antifungal drugs experienced large price increases in recent years, however, factors contributing to these price increases are poorly understood. We sought to examine trends in antifungal drug prices and determine underlying drivers of price changes.

METHODS

Antifungal drug products in the United States were identified using the Food and Drug Administration (FDA) Label database. For each product, we determined the wholesale acquisition cost per unit over time between 2000 and 2019, adjusting for inflation, and examined variables that could impact price: route of administration, number of FDA indications, the quantity of professional guideline recommendations, use for prophylaxis, number of FDA-approved manufacturers, and whether it was compounded. Price trajectories were clustered into four groups: (1) stable, 2) moderate, (3) high, and (4) extreme price increases.

RESULTS

Of 139 identified drug products, one outlier was removed due to exorbitant price increases. Cluster 1 (n = 31) demonstrated the most stable prices with a 25% mean price increase. Clusters 2 (n = 97), 3 (n = 7), and 4 (n = 3) demonstrated moderate, high, and extreme price increases with 52%, 318%, and 900% mean price increases, respectively. Atypical routes of administration and compounding were over-represented in clusters 3 and 4. There was no correlation between the number of manufacturers and price changes.

CONCLUSIONS

Antifungal drugs exhibited large, inflation-adjusted price increases. Atypical routes of administration and compounding were over-represented within clusters exhibiting extraordinary price increases. Our data support policies aiming to curb large price increases for medically important drugs.

摘要

背景

抗真菌药物可治疗多种疾病,从局部皮肤病到危及生命的全身性感染。近年来,一些常见的抗真菌药物价格大幅上涨,但导致这些价格上涨的因素尚不清楚。我们试图研究抗真菌药物价格趋势,并确定价格变化的潜在驱动因素。

方法

使用美国食品和药物管理局 (FDA) 标签数据库确定美国的抗真菌药物产品。对于每种产品,我们确定了 2000 年至 2019 年期间每单位的批发采购成本,同时考虑了通货膨胀因素,并检查了可能影响价格的变量:给药途径、FDA 适应症数量、专业指南推荐数量、预防用途、FDA 批准的制造商数量以及是否为复合制剂。价格轨迹分为四组:(1)稳定,(2)中度,(3)高和(4)极端价格上涨。

结果

在确定的 139 种药物产品中,由于价格过高,一种产品被剔除。组 1(n=31)显示出最稳定的价格,平均价格上涨 25%。组 2(n=97)、组 3(n=7)和组 4(n=3)的价格分别稳定上涨、中度上涨、高度上涨和极端上涨,平均价格分别上涨 52%、318%和 900%。非典型给药途径和复合制剂在组 3 和组 4 中更为常见。制造商数量与价格变化之间没有相关性。

结论

抗真菌药物的价格大幅上涨,经通货膨胀调整后涨幅较大。非典型给药途径和复合制剂在价格涨幅异常的组中更为常见。我们的数据支持旨在遏制重要药物大幅涨价的政策。

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