In this latest update we highlight the publication of a draft real-world evidence framework by the UK National Institute for Health and Care Excellence, and describe a press release from Germany's Institute for Quality and Efficiency in HealthCare outlining how real-world evidence submissions are not following their guidelines. We also discuss whether the lack of adherence to guidelines is due to ignorance of these guidelines on the part of manufacturers, the difficulty in achieving best practices or a failure of guidelines to comprehensively describe best practices.
Keywords: HTA; Institute for Quality and Efficiency in Health Care; National Institute for Health and Care Excellence; RWE; comparative effectiveness research; guidelines; health technology assessment; real-world evidence; real-world evidence framework.