Session (CTI)

ISSUE: EU HTAR mandates involvement of patients as key stakeholders in all aspects of HTA. In 2023-2026, EUPATI implemented the EU-funded HTA4Patients project, resulting in an easily accessible, high-quality training program preparing patients to become involved in the EU-HTA. The project also recognised that patient experience data (PED) is increasingly recognised as a source of evidence, that could complement both the regulatory review and HTA. Following guidance issued in the USA, a 2025 reflection paper by the EMA defined PED as ‘data that directly reflect the experience of a patient or carer, without input or interpretation by a healthcare professional, third party or (artificial intelligence [AI]-based) device.’ Facey et al (2026) highlight the potential role of qualitative and quantitative research into patient aspects for HTA as an additional source of information reflecting the patient-level value that is not observable in the randomised clinical trial setting.However, collection, use and appraisal by regulatory and HTA bodies globally are inconsistent. Some of them rely on submissions from patient organisations, testimonials, surveys, focus groups and lived-experience reports and use this variably.Likewise, patients and patient organisations lack understanding about their role in PED generation, analysis and use. Hence, the quality and methodologies for data gathering are still variable.HTA4Patients project revealed the opportunity to shape the role of patients in the generation of PED, arising from the progressing involvement of patients in the EU-level and national HTA processes. Consequently, first training modules on PED are being developed and integrated as part of EUPATI’s educational offerings. Complementing existing materials on PROMs, the current emphasis for new content is on patient preference studies (PPS) with patients as participants and co-designers.OVERVIEW: This panel will highlight from different stakeholder perspectives the opportunities and gaps in using PED in HTA and the resulting educational needs among patient communities.