Session (CTI)

Purpose: The purpose of the workshop is to have an interactive session with input from participants on expanding the use of patient evidence to support reimbursement, and explore whether the use of regulatory and HTA guidelines is working well or should be further strengthened. The topic will focus on whether globally patient evidence has a higher valuation due to more inclusion in regulatory and health technology guidelines, and how sponsors can include it to strengthen their case for a better value and creation of health. Participants are expected to leave the workshop empowered and better informed. Description: Katja Rudell has analysed the 2025 EMA JCA guideline and workshop slides to evaluate the impact of patient centred evidence which has always been considered nice to have in EMA 2005 regulatory guidelines on QoL. She will outline the intent of the two concepts -conceptual model and measurement model that are introduced to reduce burden and increase chances for positive outcome on trials and patient evidence. Dan Ollendorf will describe ICER’s patient engagement process in detail and highlight recent work to pilot patient-informed economic model development as well as the efforts of ICER’s overarching Patient Council. Elisabeth Oehrlein will outline frameworks to plan the inclusion of patient centered evidence that sponsors could use to plan ahead. She will draw on her experience as a patient advocate. The session is then planned to move to open-ended discussion and improvement suggestions. The interactive part will include - 2 surveys one at the start and one at the end of the session as well as knowledge checks in between the presenters. We hope to get questions about improvements to guidelines live and prepare for active participation.