In 2025, the European Union’s Health Technology Assessment (HTA) landscape will undergo a significant transformation with the implementation of the EU HTA Regulation (HTAR). This legislation will pave the way for a joint European HTA procedure, aiming to streamline assessments, reduce duplication, and enhance patient access to innovative treatments.
During our special event, Meet the Expert SPECIAL EUROPE, we were honored to have three distinguished speakers who shared invaluable insights on the implementation of the HTAR and its profound impact on healthcare decision-making. Dr. Alexander Natz (EUCOPE), Dr. Antje Behring (G-BA), and Prof. Finn Kristensen (University of Southern Denmark/Copenhagen Business School) provided their expertise and together we delved into the essential considerations and challenges that emerge within the realm of national evaluations.
Navigating the implementation of HTAR
The HTAR expands on the foundation of the current European network for Health Technology Assessment (EUnetHTA) and covers various aspects, such as Joint Clinical Assessment (JCA), Joint Scientific Consultations, horizon scanning, and voluntary cooperation. Although joint clinical reports are not obligatory for Member States, they should be appropriately taken into account during national evaluations. The European Commission, in collaboration with EUnetHTA, is actively engaged in developing procedural rules and methodologies for EU HTA to ensure a seamless transition.
National HTA bodies are responsible for evaluating the JCA reports according to their specific criteria. This entails assessing the suitability of the assessment scope, patient groups, comparators, and statistical methods in alignment with national standards. By leveraging the shared methodology and insights from the JCA reports, national HTA bodies can improve their evaluations while avoiding redundant assessments.
Addressing stakeholder concerns
The implementation of the EU HTA procedure presents specific challenges. There may be conflicts in timing due to modifications in marketing authorization texts, expedited approval processes, and varying approval timelines. Achieving synchronization between national procedure submission dates and the availability of JCA reports demands meticulous coordination and potential adjustments in national legislation.
Another challenge involves scoping and defining the Population, Intervention, Comparator, and Outcome (PICO) criteria. Balancing the consolidation of PICOs that meet the requirements of multiple Member States while minimizing their quantity poses a significant challenge. Standardizing terms, definitions, and outcome measures across countries is essential to ensure consistency and comparability in assessments.
How to get ready for 2025
To effectively prepare for the forthcoming implementation of the EU HTA Regulation in 2025, it is crucial for industry stakeholders to adjust their internal processes. This involves staying updated on the latest guidance from EUnetHTA 21, actively participating in consultations, and aligning their processes and governance models with the upcoming EU JCA process.
To ensure effective preparation, affiliates should be engaged earlier in the process to anticipate PICO components and contribute national perspectives. Additionally, processes and templates should be modified to meet JCA requirements, and HTA dossiers should be prepared well in advance of current timelines. These proactive measures will enable industry stakeholders to adapt swiftly and navigate the forthcoming changes effectively.