LAUSR

To date, there has been little agreement in the literature on what exactly constitutes radical drug innovation and how to properly measure this important construct. Without a validated measure, our ability to understand radical drug innovations, explain their origins, and demonstrate their implications for management and health policy is limited. This paper addresses the problem of radical drug innovation measurement, provides evidence of the limitations associated with the current state of the art, and offers a new method based on German health technology assessments (HTA). Data was obtained for 147 drugs authorized by the European Medicines Agency from 2011 to 2016. The innovativeness of these drugs was assessed using current measures of radical drug innovation compared with the newly developed measure. Findings indicate that current measures of radical drug innovation are associated with very inconsistent outcomes and do not appear to measure what they purport to measure. This study argues that assessing therapeutic value (as measured by the German HTA) is particularly important, given that drug novelty alone does not conclusively indicate whether a drug will deliver therapeutic value.