LEVERAGING JOINT CLINICAL ASSESSMENT TO HARMONIZE HTA DECISIONS ACROSS EUROPE
Author(s)
elena demian, MSc1, Mohit Joshi, M Pharmacy2, Florence Bianic, MSc3, Kaushik Trivedi, MA4.
1APM, Syneos Health, paris, France, 2SyneosHealth, Gurugram, India, 3Syneos Health, Paris, France, 4SYNEOS HEALTH, London, United Kingdom.
1APM, Syneos Health, paris, France, 2SyneosHealth, Gurugram, India, 3Syneos Health, Paris, France, 4SYNEOS HEALTH, London, United Kingdom.
OBJECTIVES: The Joint Clinical Assessment (JCA) started in 2025 with the aim to make clinical evidence assessments more coordinated by reducing duplication and improving consistency across Member States. This study aimed to explore methodological and policy challenges that may limit the impact of the JCA and identify practical ways to strengthen their role in supporting equitable patient access.
METHODS: A targeted literature review was conducted using EU HTA regulation documents, methodological guidance, pilot JCA case studies, national HTA frameworks in Germany, France, and Italy, and stakeholder perspectives from surveys and policy reports. The first published JCA report, on Tovorafenib, was also reviewed as an early example of how the process is working in practice.
RESULTS: The findings show that although the JCA is an important step towards a more consistent European approach to clinical evidence assessment, a few challenges remain. Different populations, comparators, and endpoints as per local standard of care led to the requirement of numerous comparators and heterogenous evidence beyond available trial data. For instance, including multiple PICOs in the JCA could lead to data gaps arising from limited or unavailable comparator evidence, or may require using indirect comparisons, such as ITCs that may affect the robustness and interpretability of the data. These issues may place pressure on manufacturers, especially when several PICOs, evidence requests, and tight timelines need to be managed simultaneously. Following the JCA, manufacturers will potentially need to submit to other European HTA bodies that may request additional analyses, adding to their complexities resulting in inconsistencies in the interpretation of the same evidence base.
CONCLUSIONS: JCA has strong potential to improve efficiency and consistency in European HTA. However, evidence gaps, methodological differences, and national requirements will impose additional burden on the manufacturers. Earlier engagement and optimized alignment on PICOs for evidence generation remains essential.
METHODS: A targeted literature review was conducted using EU HTA regulation documents, methodological guidance, pilot JCA case studies, national HTA frameworks in Germany, France, and Italy, and stakeholder perspectives from surveys and policy reports. The first published JCA report, on Tovorafenib, was also reviewed as an early example of how the process is working in practice.
RESULTS: The findings show that although the JCA is an important step towards a more consistent European approach to clinical evidence assessment, a few challenges remain. Different populations, comparators, and endpoints as per local standard of care led to the requirement of numerous comparators and heterogenous evidence beyond available trial data. For instance, including multiple PICOs in the JCA could lead to data gaps arising from limited or unavailable comparator evidence, or may require using indirect comparisons, such as ITCs that may affect the robustness and interpretability of the data. These issues may place pressure on manufacturers, especially when several PICOs, evidence requests, and tight timelines need to be managed simultaneously. Following the JCA, manufacturers will potentially need to submit to other European HTA bodies that may request additional analyses, adding to their complexities resulting in inconsistencies in the interpretation of the same evidence base.
CONCLUSIONS: JCA has strong potential to improve efficiency and consistency in European HTA. However, evidence gaps, methodological differences, and national requirements will impose additional burden on the manufacturers. Earlier engagement and optimized alignment on PICOs for evidence generation remains essential.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA50
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas