OUTLOOK Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers
OUTLOOK Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers
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DOI：
10.1038/nrd3079
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发表时间：
2010-04-01
影响因子：
120.1
通讯作者：
Pearson, Steven
中科院分区：
文献类型：
--
作者：
Eichler, Hans-Georg;Bloechl-Daum, Brigitte;Pearson, Steven
药品监管机构传统上会评估药品的质量、安全性和功效，而当前的范式规定，当收益大于风险时，新药就应该获得许可。相比之下，第三方付款人的报销决定主要基于药物相对于现有治疗方案的健康益处（称为相对疗效；RE）。过去十年，付款人的作用变得更加突出，上市时间不再意味着获得许可的时间，而是意味着报销的时间。公司现在必须满足监管机构和付款人有时不同的需求，并在上市前阶段解决问题。本文介绍了重新辩论当前的政治背景，并提出了与重新评估相关的科学和方法挑战。此外，我们还解释了稀土对药物开发的影响，并推测了未来的发展和关键参与者可能需要采取的行动。
Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address re during the pre-marketing stages. this article describes the current political background to the re debate and presents the scientific and methodological challenges as they relate to re assessment. In addition, we explain the impact of re on drug development, and speculate on future developments and actions that are likely to be required from key players.