PATIENT INVOLVEMENT IN HTA ACROSS THE EU4 AND UK: A MAPPING OF ACCESS POINTS AND INFLUENCE ACROSS HTA MILESTONES
Author(s)
Evelien de Wilt, BSc, MSc1, Katharina Ambuehl, MSc2, Christina Due, PhD1.
1Novartis Pharmaceuticals UK Ltd, London, United Kingdom, 2Novartis Pharma Services AG, Basel, Switzerland.
1Novartis Pharmaceuticals UK Ltd, London, United Kingdom, 2Novartis Pharma Services AG, Basel, Switzerland.
OBJECTIVES: Patient involvement in Health Technology Assessment (HTA) is recognised as an important component of the evidence package, improving decision-making transparency and legitimacy by incorporating the perspectives of patients who will use the technologies. Across Europe, formal frameworks exist to include the patient voice in HTA decision-making. Understanding the access points, significance, and influence of patient involvement across HTA milestones is valuable for stakeholders navigating HTA. Reflecting recent legislative changes and new patient involvement frameworks, this research aimed to create a central resource mapping HTA processes and patient access points across the European 4 (EU4; France, Germany, Italy, Spain) and United Kingdom (UK).
METHODS: Desktop searches were conducted (November-December 2025) and validated by local subject matter experts to map HTA processes to key opportunities for patient involvement and determine the influence on decision-making pre-, during-, and post-HTA, across the EU4 and UK.
RESULTS: Patient input is a formally recognised component of HTA processes across the EU4 and UK, and can contextualise disease burden, unmet need, quality of life, and the real-world impact of treatments outside of clinical trials. Pre-HTA, before formal submission, patients can be nominated for early HTA discussions (France/UK). During-HTA, patients can submit written evidence (Germany) and comment on the HTA dossier submitted by the manufacturer (Spain/UK). Patients can also attend in-person meetings with HTA bodies (EU4/UK); discussions may be informative (Italy) or considered as supporting evidence (France/Germany/Spain/UK). Post-HTA, patients can provide evidence to support regional decision-making (Italy/Spain/UK).
CONCLUSIONS: HTA bodies in the EU4 and UK provide formal opportunities for patient input across HTA, with approaches continuing to evolve. For example, Spain's draft patient association legislation, Italy's Ascolta platform, and Germany's updated General Methods framework signal increasing formalisation of HTA engagement. Greater alignment across HTA processes would help stakeholders navigate patient involvement opportunities. Continued monitoring of this environment is essential.
METHODS: Desktop searches were conducted (November-December 2025) and validated by local subject matter experts to map HTA processes to key opportunities for patient involvement and determine the influence on decision-making pre-, during-, and post-HTA, across the EU4 and UK.
RESULTS: Patient input is a formally recognised component of HTA processes across the EU4 and UK, and can contextualise disease burden, unmet need, quality of life, and the real-world impact of treatments outside of clinical trials. Pre-HTA, before formal submission, patients can be nominated for early HTA discussions (France/UK). During-HTA, patients can submit written evidence (Germany) and comment on the HTA dossier submitted by the manufacturer (Spain/UK). Patients can also attend in-person meetings with HTA bodies (EU4/UK); discussions may be informative (Italy) or considered as supporting evidence (France/Germany/Spain/UK). Post-HTA, patients can provide evidence to support regional decision-making (Italy/Spain/UK).
CONCLUSIONS: HTA bodies in the EU4 and UK provide formal opportunities for patient input across HTA, with approaches continuing to evolve. For example, Spain's draft patient association legislation, Italy's Ascolta platform, and Germany's updated General Methods framework signal increasing formalisation of HTA engagement. Greater alignment across HTA processes would help stakeholders navigate patient involvement opportunities. Continued monitoring of this environment is essential.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA217
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas