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在美国销售的骨质疏松症药物:仿制药竞争、定价结构及支付方之间的差异

OSTEOPOROSIS DRUGS MARKETED IN THE UNITED STATES: GENERIC COMPETITION, PRICING STRUCTURE, AND DISPERSION AMONG PAYERS.

作者信息

Balkhi Bander, Seoane-Vazquez Enrique, Rodriguez-Monguio Rosa

机构信息

Massachusetts College of Pharmacy and Health Sciences,Pharmaceutical Sciences.

University of Massachusetts,Amherst - Health Policy and

出版信息

Int J Technol Assess Health Care. 2016 Jan;32(6):385-392. doi: 10.1017/S0266462316000623. Epub 2017 Jan 9.

Abstract

BACKGROUND

Despite the cost of pharmaceuticals, studies assessing prices of osteoporosis drugs are lacking. This study examined trends in prices of osteoporosis drugs in the United States in the period 1988-2014, assessed pricing structure of osteoporosis drugs, and evaluated price trends before and after generic drugs market entry.

METHODS

Data were derived from the U.S. Food and Drug Administration, the RedBook, the Centers for Medicare & Medicaid Services, and the Federal Supply Schedule (FSS). Descriptive statistics and segmented linear regression analyses were performed.

RESULTS

In the period 1988-2014, osteoporosis drug prices increased faster than the inflation. The average wholesale price (AWP) of generic products at market entry represented 90 percent of the AWP for the corresponding brand. Prices of brand products continued to increase after generic entry. Drug prices showed a significant variation when compared with the brand AWP. The brand wholesale acquisition cost (WAC) was typically set at 83.3 percent of the AWP. Community pharmacies acquired osteoporosis brand drugs at a median of 80.5 percent of the brand AWP. Significant reductions in brand AWP were observed for Medicare Part B (78.5 percent of the brand AWP), generic National Average Drug Acquisition Cost (33.7 percent), and FSS (22.5 percent).

CONCLUSIONS

There are significant differences in the manufacturer prices, pharmacy acquisition costs and reimbursement rates of osteoporosis drugs. Pharmaceutical companies listed prices are higher than the pharmacy actual estimated acquisitions costs, and the prices used for reimbursement to providers. Generic drugs entry significantly drives down prices; still, prices of branded drugs facing generic competition continued to increase after generic market entry.

摘要

背景

尽管药品成本高昂,但评估骨质疏松症药物价格的研究却很匮乏。本研究调查了1988年至2014年期间美国骨质疏松症药物的价格趋势,评估了骨质疏松症药物的定价结构,并评估了仿制药进入市场前后的价格趋势。

方法

数据来源于美国食品药品监督管理局、《红皮书》、医疗保险和医疗补助服务中心以及联邦供应时间表(FSS)。进行了描述性统计和分段线性回归分析。

结果

在1988年至2014年期间,骨质疏松症药物价格的增长速度超过了通货膨胀率。仿制药进入市场时的平均批发价(AWP)占相应品牌AWP的90%。仿制药进入市场后,品牌产品的价格仍在继续上涨。与品牌AWP相比,药品价格存在显著差异。品牌批发采购成本(WAC)通常设定为AWP的83.3%。社区药房采购骨质疏松症品牌药物的价格中位数为品牌AWP的80.5%。医疗保险B部分(品牌AWP的78.5%)、仿制药全国平均药品采购成本(33.7%)和FSS(22.5%)的品牌AWP均有显著降低。

结论

骨质疏松症药物在制造商价格、药房采购成本和报销率方面存在显著差异。制药公司列出的价格高于药房实际估计的采购成本以及用于向供应商报销的价格。仿制药的进入显著压低了价格;不过,面临仿制药竞争的品牌药价格在仿制药进入市场后仍在继续上涨。

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