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美国心脏协会关于药物和生物制剂可及性和可负担性的原则:美国心脏协会的总统顾问报告。

American Heart Association Principles on the Accessibility and Affordability of Drugs and Biologics: A Presidential Advisory From the American Heart Association.

出版信息

Circulation. 2017 Dec 12;136(24):e441-e447. doi: 10.1161/CIR.0000000000000551. Epub 2017 Nov 9.

DOI:10.1161/CIR.0000000000000551
PMID:29122813
Abstract

Net US spending on pharmaceuticals reached $309.5 billion in 2015, an 8.5% increase from the year before, and is expected to reach between $370 and $400 billion by 2020. These current and projected levels have raised serious concerns by policy makers, providers, payers, and patient groups that they are unsustainable and threaten the affordability of and accessibility to much-needed therapies for patients. Two trends related to drugs/biologics and generic drugs/biosimilars underlie this overall increase in spending. First, the market entry prices of innovator pharmaceutical products, or brand drugs and biologics, are at levels that some assessments consider unaffordable to the healthcare system. Second, prices for some established generic drugs such as digoxin and captopril have seen sharp and rapid increases. As an evidence-based patient advocacy organization dedicated to improving the cardiovascular health of all Americans, the American Heart Association has a unique role in advocating for treatments, including medicines that are available, affordable, and accessible to patients. This advisory serves to lay out a set of principles that will guide association engagement in pursuit of this goal.

摘要

2015 年,美国的药品净支出达到 3095 亿美元,比前一年增长 8.5%,预计到 2020 年将达到 3700 亿至 4000 亿美元。这些当前和预计的支出水平引起了政策制定者、提供者、支付者和患者群体的严重关注,他们认为这些支出水平不可持续,并威胁到患者所需疗法的可负担性和可及性。导致这种整体支出增长的两个趋势与药品/生物制剂和仿制药/生物类似药有关。首先,创新药物产品(即品牌药物和生物制剂)的市场进入价格处于一些评估认为医疗体系无法承受的水平。其次,一些已上市的仿制药,如地高辛和卡托普利的价格出现了急剧而快速的上涨。作为一个致力于改善所有美国人心血管健康的循证患者倡导组织,美国心脏协会在倡导包括可获得、负担得起和可及的药物在内的治疗方法方面具有独特的作用。本咨询报告旨在阐述一系列指导协会参与实现这一目标的原则。

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