How to Determine Unmet Needs for More Needs-Driven Product Development and Healthcare Decision-Making?

ISSUE: Identifying unmet medical needs is essential for needs-driven product development and healthcare decision-making. Although agreement exists on the importance of focusing research and development on unmet needs, varying interpretations exist towards the meaning and concept of unmet needs, and their identification and application in product evaluation and healthcare decision-making. This session discusses, through a multi-stakeholder lens, challenges and opportunities for unmet need identification and structured assessment in decision-making.

OVERVIEW: This session will highlight insights from different stakeholders (Policy, HTA, academia, patient) on i) the concept of unmet need (distinguishing between patient and societal need), ii) the identification of unmet needs, and iii) avenues for their more systematic integration and assessment in healthcare decision-making, highlighting current and novel methodological approaches and case studies. Opportunities and challenges will be discussed in view of the new European pharmaceutical legislation where the concept of ‘Unmet medical needs’ is centrally embedded. A concrete case example on unmet needs identification, which is currently under development by the Belgian Health Care Knowledge Centre (KCE) in collaboration with academia, will be showcased. Furthermore, the session will delve into unmet need determination in the context of rare diseases, highlighting specific challenges, methodological considerations, and insights from the patient perspective. Speakers will address the current status and challenges, and highlight novel methodological approaches and learnings derived from concrete case studies. Panellists will have 10 min presentation time. 25 minutes are foreseen for discussion during which attendees’ opinions will be probed using the ISPOR polling tool. Multiple stakeholder groups will benefit from attending this issue panel including policymakers, HTA assessors, payers, regulators, patient representatives, academics, pharmaceutical industry, and market access representatives.