Title: Repurposing evidentiary standards and evaluation in practice
Authors: Virginia Acha - MSD (United Kingdom) [presenting]
Adrian Towse - Office of Health Economics (United Kingdom)
Abstract: The aim is to address the challenges of defining repurposing and the resulting confusion in evidentiary requirements and regulatory review to support use for patients in practice. These challenges have been made more acute by the social conflicts in incentives and understanding, resulting from wider scope of stakeholders directly engaging in establishing what appropriate evidentiary standards and evaluation should be and where responsibility and accountability for these should lie. We use recent examples from the UK to illustrate these points, and conclude with proposals for new research to address the gaps.