Presentation (CTI)

OBJECTIVES: The European Union Health Technology Assessment (EU-HTA) regulation aims to harmonize health technology assessments across EU member states, thereby fostering collaboration and reducing redundancies. This study investigates the readiness of market access experts in various European countries for the implementation of the EU-HTA regulation and explores its potential influence on national HTA frameworks.
METHODS: A structured questionnaire was developed and distributed to market access experts in multiple European countries. The survey was conducted in two phases: before and after the regulation’s enactment. This longitudinal approach enabled a comparative analysis of readiness, perceptions, and the regulation’s potential impact on national HTA processes. Key areas of focus included awareness of the EU-HTA regulation, perceived challenges, and the extent of its influence on national policies.
RESULTS: The findings reveal both similarities and differences in readiness across countries, reflecting the diversity of national HTA regulations within the EU. The study also highlights variations in the influence of the European regulation on national HTA frameworks. While some countries implemented comprehensive adaptations early on to align with EU requirements, others took a wait-and-see approach and have largely maintained independent procedures to date.
CONCLUSIONS: This survey provides valuable insights into the current alignment of national HTA procedures with the EU-HTA regulations. It highlights the varying levels of preparedness among different countries. Since release of the guidelines on frameworks was so close before the EU-HTA regulation came into force, countries waited to implement adaptations within their national HTA procedures. Further, the extent of adaptations depends on the already existing national HTA regulations. It is becoming apparent that countries are now taking a step in the direction of EU-HTA and initiating the necessary adjustments to achieve the goal of harmonizing European HTA and avoiding redundancy.