DIA Europe 2024

The concept of unmet medical need (UMN) plays an important role in investment and priority-setting decisions by a range of stakeholders, including regulators, HTA agencies, payers, academics and the pharmaceutical industry. Identifying a particular condition or disease area as an UMN is intended to signal its health policy significance, stimulate research activities and incentivise the development of innovative treatments, diagnoses or health technologies in these areas. Incentives associated with the identification of an UMN can take the form of preferential access to public research funds, access to alternative or accelerated regulatory pathways, consideration of UMN as a value element in HTA, and financial incentives or innovative payment models in reimbursing the health benefits a new treatment delivers. As UMN should help to shape policy and action from early phase research, through clinical development to pricing and reimbursement to how a new medicine is used in practice, how the research and healthcare communities define and quantify unmet medical need is challenging as every patient’s perspective is very personal according to their own experience of living with disease and each constituency’s view of unmet need is formed by their own professional expertise and opinion.?? As the European Commission proposed to define the concept of UMN in the current legislative review, the concept is broadly discussed with divergent views. The session will bring together key players in pharmaceutical innovation from developers, health and regulatory authorities, patients to discuss Europe’s ambition for a definition of unmet medical need, what is needed and what are challenges.