International comparison of assessments of pharmaceutical innovation

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• 作者：Joel Lexchin^a ; ^b ; ^c ; ^{jlexchin@yorku.ca}
• 关键词：Canada ; Drug regulation ; Review status ; Therapeutic innovation
• 刊名：Health Policy
• 出版年：2012
• 期刊代码：110_01688510
• 类别：med
• 出版时间：May, 2012
• 卷：105
• 期：2-3
• 页码：221-225
• 文件大小：176 K

摘要

Introduction

This study was undertaken to compare decisions about medicines innovation made by two Canadian organizations, the Therapeutic Products Directorate (TPD) and the Human Drug Advisory Panel (HDAP), with those made by similar organizations in other countries.

Methods

Assessments by TPD and HDAP were compared to those made by the Food and Drug Administration (FDA) and the drug bulletin Prescrire International, respectively.

Results

Between 2004 and 2009 the TPD gave priority reviews to 46 of 137 (34%) products compared to 71 of 145 drugs (49%) by the FDA (p = 0.011). Of 109 drugs in common the two agreed on the review status in 88 (weighted Kappa = 0.606). In the same time period HDAP categorized 12 of 120 (10%) drugs as innovative while Prescrire did the same for 49 of 624 (8%) new drugs and new indications for older drugs (p = 0.4664). Of 84 drugs in common the two agreed on the evaluation for 70 (weighted Kappa = 0.319).

Discussion

Differences between the different organizations may be due to a variety of factors. These differences have significant policy implications.