Presentation (CTI)

OBJECTIVES: To examine the strategic importance of patient experience data (PED) within the EU health technology assessment (HTA) regulation and joint clinical assessment (JCA), as well as to highlight emerging practices for the integration of PED to enhance value demonstration with regard to both European and national HTA requirements.
METHODS: A review of selected regulatory guidance documents (EU HTA Regulation 2021/2282), documented consultations (EMA-HTA bodies parallel consultations) and documented key framework and initiatives (IMI project, ISPOR reports, and EUPATI toolbox) was conducted.
RESULTS: First, PED is positioned to play an instrumental role in the EU JCA, where it is expected to evaluate outcome selection, supporting value claims, and aiding alignment with national HTA. It helps prioritise outcomes during PICO scoping and strengthen value claims when clinical evidence is limited. A case study from France showed that data from validated Quality of Life (QoL) measures (HPES and SF-36) significantly contributed to securing an autonomous sensory meridian response ASMR (improved medical service) level IV rating by the French HTA body. In contrast, a comparable case lacking both QoL data and a supportive report from the patient association. Second, early engagement with EMA and HTA bodies through the joint scientific consultation (JSC) allows proactive validation of PED endpoints. Lastly, transparent governance and conflict of interest management are essential for credible patient input.
CONCLUSIONS: In the evolving EU HTA landscape, PED is a strategic differentiator. Integrating patient insights from early development through commercialisations vital to optimise JCA outcomes and secure national reimbursement. To ensure robust evidence evaluation relevant for JCA, these measures need to be fit for purpose. Transparent PED governance and early alignment with HTA expectations will be key to demonstrating true value and achieving market access success.