Enhancing Patient Involvement in European Health Technology Assessment (HTA): From Inconsistent National Practices to Systematic Engagement in Joint Clinical Assessments
Author(s)
Justyna Tomassy, MSc1, Lucia Perez-Kempner, MBS, MSc2, Ioana Horea, MSc3, Sangeeta Budhia, BSc, MSc, PhD4.
1Parexel, Krakow, Poland, 2Parexel International, Lebrija, Spain, 3Parexel International, Bucharest, Romania, 4Parexel International, London, United Kingdom.
1Parexel, Krakow, Poland, 2Parexel International, Lebrija, Spain, 3Parexel International, Bucharest, Romania, 4Parexel International, London, United Kingdom.
OBJECTIVES: This research aims to investigate the existing differences in patient engagement policies for Health Technology Assessment (HTA) across countries. It also assesses how the Joint Clinical Assessment (JCA) regulatory framework impacts standardizing patient engagement in the evaluation of medicines.
METHODS: Desktop research was conducted on patients' involvement in HTA processes across Canada, Denmark, France, Italy, Norway, Poland, Spain, Sweden, UK to identify methodologies and policies published by each HTA body. The JCA regulatory framework and procedural guidance were examined and compared with the national practices.
RESULTS: Patient involvement in HTA varies across countries. Most HTA bodies analyzed follow formalized processes and include patient perspective into the final assessment reports (Canada, Denmark, England, Norway, Scotland, Sweden). Some HTA bodies (Canada, Catalonia, Denmark, France, Sweden) grant patients voting rights in the appraisal process, while others (England, Norway, Poland, Scotland) allow participation in committee meetings without voting. Italy has limited patient engagement, and Spain lacks transparency in how patient insight is integrated into decisions, despite existing regulations for involvement. JCA regulations mandate patient input via questionnaires and meetings, with written contributions required during scoping and review of the draft report . The JCA subgroup may seek input from patient organizations throughout the JCA process. Patient selection should be established after receiving information on upcoming marketing authorization applications.
CONCLUSIONS: JCA is standardizing the process for patient involvement, which is currently irregular across the different HTA bodies. Increased patients’ involvement in the JCA decision-making can set an example for HTA agencies with limited patients engagement practices, or agencies lacking a clear framework. This emphasizes the importance for manufacturers and Health Technology Developers (HTDs) to integrate patient perspective early in evidence generation strategies, including developing transparent methods for patient-reported outcomes, aligning teams on patient-centric approaches, aligning with EU guidance, and ensuring the patient voice is captured in submissions.
METHODS: Desktop research was conducted on patients' involvement in HTA processes across Canada, Denmark, France, Italy, Norway, Poland, Spain, Sweden, UK to identify methodologies and policies published by each HTA body. The JCA regulatory framework and procedural guidance were examined and compared with the national practices.
RESULTS: Patient involvement in HTA varies across countries. Most HTA bodies analyzed follow formalized processes and include patient perspective into the final assessment reports (Canada, Denmark, England, Norway, Scotland, Sweden). Some HTA bodies (Canada, Catalonia, Denmark, France, Sweden) grant patients voting rights in the appraisal process, while others (England, Norway, Poland, Scotland) allow participation in committee meetings without voting. Italy has limited patient engagement, and Spain lacks transparency in how patient insight is integrated into decisions, despite existing regulations for involvement. JCA regulations mandate patient input via questionnaires and meetings, with written contributions required during scoping and review of the draft report . The JCA subgroup may seek input from patient organizations throughout the JCA process. Patient selection should be established after receiving information on upcoming marketing authorization applications.
CONCLUSIONS: JCA is standardizing the process for patient involvement, which is currently irregular across the different HTA bodies. Increased patients’ involvement in the JCA decision-making can set an example for HTA agencies with limited patients engagement practices, or agencies lacking a clear framework. This emphasizes the importance for manufacturers and Health Technology Developers (HTDs) to integrate patient perspective early in evidence generation strategies, including developing transparent methods for patient-reported outcomes, aligning teams on patient-centric approaches, aligning with EU guidance, and ensuring the patient voice is captured in submissions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA124
Topic
Health Policy & Regulatory, Health Technology Assessment, Patient-Centered Research
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas