ISSUE: The panel will debate, with diverse perspectives, (1) how the spectrum of stakeholders can jointly improve the process of demonstrating benefit/risk and value in the challenging environment of adaptive pathways with greater uncertainty, (2) the role of RWE to support conditional authorisation and market access, and which areas still require further development, (3) the current limitations to implementing value-based MEAs in Europe and potential ways forward, (4) the role of the patient community to enhance early access initiatives as mediators and decision-makers on national and European levels. To allow for a maximum of debate, the panelists will each give a 5-minute introduction, followed by a 30-minute panel discussion and 15 minutes of Q&A. OVERVIEW: Patients are often willing to accept greater risks from treatment of life-threatening diseases in return for earlier access. Their rising influence puts focus on rapid development and faster access to potentially transformative medicines. Better defined, smaller patient populations and the need for speed challenge established development pathways and regulatory, HTA and pricing systems. In response, paradigms of biomedical innovation are being transformed with “Adaptive pathways”. In order to achieve equitable and timely access for patients with unmet needs, market access and reimbursement in step with earlier conditional marketing authorisation is essential. However, uncertainty about whether the anticipated clinical benefits will be verified and the possibility of undiscovered risks pose challenges to HTA bodies. With greater uncertainty, a novel medicine’s price should no longer be determined at first market entry, but be governed by more flexible approaches that reflect the emerging evidence generated. Patient-centered RWE presents a significant opportunity to enhance early access regulatory decision-making and adaptive value-based contracting centred on mutually agreed outcomes and set milestones. Nonetheless, opinions on RWE remain diverse. Questions raised by stakeholders concern the methodology, reliability and the usefulness of RWE in decision-making.