Presentation (CTI)

OBJECTIVES: The EU HTA Regulation (2021/2282) mandates patient involvement in Joint Clinical Assessments, increasing attention to the patient’s role in health technology assessment (HTA). This systematic review aimed to examine how patient involvement in HTA is organized across Europe, comparing Belgium with peer countries and to formulate actionable recommendations for the Belgian payer.
METHODS: PubMed was searched for publications from January 1, 2016 to June 1, 2026, combining terms for HTA patient participation/engagement, and European countries. A structured data extraction framework summarised the purpose, timing, level and methods of patient involvement, patient profiles, and reported barriers across countries. To complement the review, European HTA bodies were surveyed on current practices and future plans for patient involvement.
RESULTS: A total of 17 studies covering 15 European countries met the inclusion criteria. Written submissions are the predominant form of patient involvement across Europe. The UK (NICE) and France (HAS) have the most comprehensive frameworks including patient expert consultations, public hearings, early scientific dialogue, and in the UK, patient participation in managed entry agreement negotiations. Germany (G-BA) provides a formal patient petition mechanism, and Scotland (SMC) offers a dedicated pathway for orphan medicines, where patient testimony is a key input given limited clinical evidence. Central and Eastern Europe remain more fragmented and less formal. Belgium includes the use of patient questionnaires and a non-voting patient representative in the reimbursement committee, however patient involvement remains limited and lacks a structured approach. Two challenges emerged in Europe: absence of feedback mechanisms despite substantial investments by patient organisations, and no consensus on the definition of patient involvement, hindering cross-country comparisons.
CONCLUSIONS: Patient involvement in European HTA remains largely consultative and fragmented. Structured feedback mechanisms, a harmonised definition, and inclusive frameworks are urgently needed. Belgium should build on its existing mechanisms to ensure patient input is demonstrably integrated, not merely collected.