ISSUE: Health technology manufacturers seek early dialogues with health technology assessment (HTA) bodies and regulators to gain advice on their evidence generation plans and insights on how these agencies are likely to assess technologies within a disease area. Not all agencies involve patients in this process and this panel will debate the value gained versus the burden of patient involvement. OVERVIEW: Is patient involvement in early HTA dialogues a useful stakeholder perspective that adds value to the early advice, or an unnecessary burden? This is a critical debate as patients become more involved in medicines development and HTA decision-making. Many HTA agencies have processes for patient involvement in the assessment of health technologies, but few include patients in early scientific advice. The burden: There exist many barriers to patient involvement in this process; identifying the patient who can contribute, setting expectations on the patients’ pre-knowledge, training and support for patients, having staff and processes to administer the process, confidentiality, and defining clear roles for the parties giving the advice. The value: Those agencies that have included patients maintain that the value outweighs these challenges. In particular, patients bring a perspective and experience that no other stakeholder can replicate; the day-to-day experience of a condition; practical challenges with current management approaches; weighting of symptoms that most affect their lives; experience with current standards of care; experience as a participant of clinical studies. Resources within agencies are limited. So this panel will explore the various points of view. The audience will have the opportunity to discuss the processes from EUnetHTA and NICE via case studies, and join in the debate with the panel. A new IMI consortium, PARADIGM, has been tasked with determining why and how patients can be included in early dialogues and this debate will be a timely input into their work.