Presentation (CTI)

OBJECTIVES: The EU HTA Regulation positions patient involvement as a core element of the Joint Clinical Assessment (JCA), including participation in scoping, reviews of draft assessments, and strategic feedback through the Stakeholder Network. This aims to ensure health technology assessment (HTA) reflects real-world patient experiences and preferences. This research aims to explore HTA representatives’ perceptions on the extent to which patient input will meaningfully shape JCAs under the EU HTA Regulation.
METHODS: Primary research with 6 HTA representatives from France, Germany, Hungary, Italy, Poland, and Spain explored how EU HTA Regulation provisions may enable meaningful patient involvement in the JCA process and the potential barriers to such involvement. The selection of these countries ensured institutional diversity across the EU, supporting understanding of how the Regulation may be interpreted and implemented within national HTA processes.
RESULTS: HTA representatives acknowledged that patient collaboration can play a meaningful role in the JCA process, particularly in reviewing draft JCA summary reports and providing strategic feedback through the Stakeholder Network. While patient perspectives were broadly valued, their perceived importance relative to other sources like national clinical guidelines varied. Countries with established engagement frameworks like Germany were more optimistic about strengthening patient involvement under the Regulation. However, countries without formal processes for patient involvement in HTA such as Italy, cited barriers like limited resources and scepticism toward patient input as ‘hard’ evidence. Additional concerns included the timeliness of input and limited awareness of involvement opportunities among patient organisations, especially in countries without well-established national organisations. Proposed solutions included EU-wide real-world evidence harmonisation, defined milestones for patient involvement at national level, and leveraging initiatives like EUCAPA to enhance patient readiness.
CONCLUSIONS: While the Regulation’s provisions for structured patient involvement are welcomed, meaningful impact will depend on addressing national-level barriers and ensuring consistent support for patient engagement across diverse HTA systems.