During this session, based on the work of RWE4Decisions, new actions for all stakeholder groups will be presented and documented and those for HTA, Industry and Analytics Groups will be discussed, emphasizing the evolving policy and system developments supporting the actions in the EU. François Meyer will facilitate a conversation among the panelists and the audience about the applicability of these actions in their day-to-day work and the implications for JSCs and JCAs in EU HTA. The goal of the session is to provide concrete actions that each stakeholder group can take to improve the accessibility and quality of RWD and improve the use of high-quality RWE studies in HTA decision-making.

RWE4Decisions is a multistakeholder learning network that facilitates stakeholder dialogues over the life cycle of highly innovative medicines. It seeks to identify the real-world evidence needed to inform HTA/Payer decisions, clarifying how RWE will be assessed and supporting effective implementation of Post-Launch Evidence Generation. RWE4Decisions used a mixed methods approach involving HTA/Payers, industry, clinicians, patient groups, analytics experts and registry holders in the EU and Canada over the past year to develop a set of actions to build better RWE for HTA (updating actions from a previous 2020 publication.)