NEED assessment framework 2025: EU expert consensus and core version

KCE Reports 401C (2025)

The goal of the NEED initiative is to assess patients’ and society’s unmet health-related needs in a scientific and structured way. This information, collected in a dedicated database, can then be used to inform innovation and healthcare policies to help them target the areas of highest need.

In 2024, the NEED research team developed a framework for assessing unmet needs for a given disease or health condition. Since then, it has been working tirelessly to refine the framework, taking on board the lessons learnt from two case studies and from an additional study on the applicability of the concept to rare diseases. It has also developed a methodology for the identification and selection of the health conditions to be assessed.

More recently, the framework was submitted to 26 experts from 17 EU member states in order to reach a consensus on its general structure and on its individual components (the criteria and indicators used to assess health-related needs). This is an important step to ensure the acceptability and relevance of the framework across diverse European contexts.

This new report presents the latest version of the framework following the European consensus and an internal team discussion. It also introduces a core version of the framework containing the minimally required criteria for a meaningful assessment of unmet health-related needs. This will hopefully speed up the process of filling up the NEED evidence database, as these core assessments, while still relevant to inform healthcare planning and decision-making, will require less time and resources.