Evolving JCA Perspectives From EU Stakeholders and the Impact on Manufacturers
Author(s)
Jessica Counihan, PhD1, Ismail Ismailoglu, PhD2, Alexis Bryan, BS, MPH3.
1Trinity Life Sciences, Colorado Springs, CO, USA, 2Trinity Life Sciences, Minneapolis, MN, USA, 3Trinity Life Sciences, Brooklyn, NY, USA.
1Trinity Life Sciences, Colorado Springs, CO, USA, 2Trinity Life Sciences, Minneapolis, MN, USA, 3Trinity Life Sciences, Brooklyn, NY, USA.
OBJECTIVES: The Joint Clinical Assessment (JCA) became mandatory in Europe this January. Previous research has aimed to evaluate the potential impact of widespread European adoption of the JCA as a new requirement for Health Technology Assessments (HTA). As the official implementation recently occurred, this research aims to understand the state of implementation and evolving HTA stakeholder perceptions. This research also looks at how manufacturers are adapting their EU submission preparations.
METHODS: This study presents the results of primary research from N=8 ex-HTA stakeholders across Germany, France, Italy, and Spain to provide current perceptions of the JCA and its impact on manufacturer preparedness. We also utilize retrospective interview results from 2024/2023 to explore the evolution of payers' perceptions/knowledge of JCA.
RESULTS: Retrospective research found that most payers have high confidence in the parameters and evaluation criteria within the JCA. However, countries were still planning to conduct their own supplemental clinical assessments, which creates redundancies. Italian and Spanish payers were working to implement a cost-effectiveness evaluation upon JCA implementation, but the level of integration remains unclear. German payers reported seamless integration of the JCA into their current system given alignment of local priorities with the JCA parameters, whereas French payers experienced some adoption inertia. From the manufacturer perspective, companies are increasingly engaging with HTA bodies earlier to align clinical trial designs (e.g., selecting appropriate comparators and endpoints) to meet JCA requirements across all participating member states. Increased complexity has required manufacturers to dedicate additional resources to ensure comprehensive evidence generation and stakeholder engagement.
CONCLUSIONS: Overall, this research suggests that while the JCA has been well-received by payers across Europe, there is still some work to be done to ensure efficient implementation. Additionally, implementation of the JCA is prompting significant changes in how drug manufacturers operate in Europe.
METHODS: This study presents the results of primary research from N=8 ex-HTA stakeholders across Germany, France, Italy, and Spain to provide current perceptions of the JCA and its impact on manufacturer preparedness. We also utilize retrospective interview results from 2024/2023 to explore the evolution of payers' perceptions/knowledge of JCA.
RESULTS: Retrospective research found that most payers have high confidence in the parameters and evaluation criteria within the JCA. However, countries were still planning to conduct their own supplemental clinical assessments, which creates redundancies. Italian and Spanish payers were working to implement a cost-effectiveness evaluation upon JCA implementation, but the level of integration remains unclear. German payers reported seamless integration of the JCA into their current system given alignment of local priorities with the JCA parameters, whereas French payers experienced some adoption inertia. From the manufacturer perspective, companies are increasingly engaging with HTA bodies earlier to align clinical trial designs (e.g., selecting appropriate comparators and endpoints) to meet JCA requirements across all participating member states. Increased complexity has required manufacturers to dedicate additional resources to ensure comprehensive evidence generation and stakeholder engagement.
CONCLUSIONS: Overall, this research suggests that while the JCA has been well-received by payers across Europe, there is still some work to be done to ensure efficient implementation. Additionally, implementation of the JCA is prompting significant changes in how drug manufacturers operate in Europe.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA142
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas