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美国的抗寄生虫药物——通往高价的两条途径。

Antiparasitic Drugs in the United States-Two Roads to High Prices.

作者信息

Shahriar Arman A, Alpern Jonathan D

机构信息

University of Minnesota Medical School, Minneapolis, MN, United States.

HealthPartners Institute, Bloomington, MN, United States.

出版信息

Front Sociol. 2020 Oct 22;5:540478. doi: 10.3389/fsoc.2020.540478. eCollection 2020.

Abstract

High prescription drug prices contribute significantly to healthcare spending in the United States and compromise patients' access to quality medical care. A number of factors allow drug manufacturers to set much higher prices in the US than in other comparable high-income nations. Price-control depends primarily on the entry and persistence of generic products following the expiration of the market exclusivity period granted to the manufacturer of the brand name drug. Unfortunately, barriers to generic entry are common, allowing off-patent drugs like albendazole to remain relatively expensive despite having been marketed in the US for decades. By contrast, miltefosine became FDA approved more recently and has maintained a high price tag by way of a novel incentive program-the neglected tropical disease (NTD) priority review voucher (PRV) program. The voucher has a high market value and can be sold or transferred well before the drug for which it was awarded becomes available on the market. While both drugs are used to treat parasitic infections that are uncommon in the US, they differ by market and regulatory conditions-each telling an interesting pricing story.

摘要

高处方药价格在美国医疗保健支出中占比显著,并影响患者获得优质医疗服务的机会。多种因素使得药品制造商在美国设定的价格远高于其他类似的高收入国家。价格控制主要取决于在品牌药制造商的市场独占期到期后仿制药的进入和持续供应。不幸的是,仿制药进入市场存在诸多障碍,使得像阿苯达唑这种已在美国上市数十年的非专利药价格依然相对较高。相比之下,米替福新最近才获得美国食品药品监督管理局(FDA)批准,并且通过一项新型激励计划——被忽视热带病(NTD)优先审评券(PRV)计划维持了高昂的价格。该审评券具有很高的市场价值,在其对应的药品上市之前很久就可以出售或转让。虽然这两种药物都用于治疗在美国不常见的寄生虫感染,但它们在市场和监管条件方面存在差异——各自都有着有趣的定价故事。

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本文引用的文献

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Changes in Price for Generic Drugs in the USA, 2008-2016.2008 - 2016年美国仿制药价格变化
J Gen Intern Med. 2019 Sep;34(9):1677-1679. doi: 10.1007/s11606-019-05033-3.
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Broken drug markets in infectious diseases: Opportunities outside the private sector?传染病领域的药品黑市:私营部门之外的机会?
PLoS Negl Trop Dis. 2019 Apr 11;13(4):e0007190. doi: 10.1371/journal.pntd.0007190. eCollection 2019 Apr.
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The Real Cost of the US Health Care System.美国医疗保健系统的实际成本。
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