What Is “Unmet Medical Need?”

A Multistakeholder Panel Addresses the Challenges in the Lack of a Common Definition


Glasgow, Scotland, UK—6 November 2017—ISPOR, the professional society for health economics and outcomes research (HEOR), held a session this afternoon at its 20th Annual European Congress in Glasgow, Scotland, UK that explored the question, “what is ‘unmet medical need?’”

The issue panel, “Unmet Medical Need: Should Stakeholders Align on a Definition?” [IP3], was moderated by Claudine Sapede, PharmD, MSc, F. Hoffmann-La Roche Ltd, Basel, Switzerland. Panelists included Nicola Bedlington, European Patients’ Forum and The Patient Access Partnership PACT, Brussels, Belgium; Neil McAuslane, PhD, Center for Innovation in Regulatory Science, London, UK, and Jo De Cock, MS, INAMI—Institut National de l’Assurance Maladie-Invalidité, Brussels, Belgium.

Addressing unmet medical need in drug development is a key criterion for medicine prioritization. It is also one of the requirements a molecule candidate needs to satisfy in order to qualify for an adaptive pathways approach and a number of accelerated regulatory review processes, such as PRIME.

A common definition of the term “unmet medical need,” however, does not exist. The interpretation of the term may also vary between various stakeholder groups (e.g., regulators, payers, patients, medicine developers). Additionally, the definitions and interpretations of the term may vary between countries and constituents. This lack of common understanding leads to significant challenges in achieving stakeholder alignment on a medicine’s eligibility for accelerated development and patient access pathways.

These issues have also been identified by the World Health Organization and the European Parliament that have called on the European Union Commission to define clearly the concept of unmet medical need and on stakeholders to explore new ways of delivering affordable medicines.

The multistakeholder panel examined these issues and presented  various perspectives on how the interpretation of unmet medical need will impact pricing and reimbursement decisions in global health care systems.

Additional information on the ISPOR 20th Annual European Congress can be found here. Released presentations from the congress can be found here. Interested parties can follow news and developments from the congress on social media using the hashtag #ISPORGlasgow.



ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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