Navigating the Joint Clinical Assessment (JCA) implementation: An analysis of EU member states readiness, challenges and opportunities for harmonization

On 12 January, the European Union (EU) and its 27 member states are set to implement a major change in how health technologies are assessed, with the introduction of Joint Clinical Assessment (JCA). JCA will harmonize the assessment process through member state collaboration to evaluate the clinical evidence safety of new health technologies, however, the JCA will not contain any value judgments or conclusions on clinical added value and is non-binding. The JCA aims to facilitate the timely and coordinated assessment of health technologies to support informed decision-making and improve patient access. Products initially in scope for JCA are new oncology and advanced therapy medicinal products (also known as cell and gene therapies). 

JCA requires EU Member State participation, alongside the involvement of stakeholders such as regulatory agencies, health technology assessment (HTA) bodies, and patient representatives. While the JCA may provide additional evidence and insights for the regulatory decision-making process, marketing authorization remains an independent process of this new framework. Still, the European Medicines Agency (EMA) will contribute to JCA by providing updates on the steps in the marketing authorization process and information on any substantial questions or outstanding issues that might impact the assessment. 

JCA does not replace the national reimbursement process or pricing negotiations currently utilized by EU Member States but aims to complement existing procedures by providing a framework for collaboration and information sharing. The JCA evaluation will be published on a publicly accessible platform, and as part of the JCA requirements, any HTA evaluation available at dossier submission should be appended to the JCA dossier.  As part of the collaboration, the JCA scope should reflect the needs of each Member State. This will be achieved by inputs provided by Member States on the Population, Intervention, Comparator, and Outcomes (PICO) parameters that will define the research question for the assessment. The JCA report will inform national reimbursement and patient access decision-making processes, including pricing decisions. However, the JCA report is non-binding; it does not provide value judgments or conclusions on added clinical value. Manufacturers will not be involved in the PICOs scoping process, but they will be invited to engage with the HTA CG (HTA commissioning group) in a scoping explanation meeting.  

To facilitate the member state involvement and readiness for JCA, the European Commission has held panel sessions including representatives from the Ministry of Health (MoH), regulatory agencies, and HTA bodies from the 27 member states, to understand how prepared each member states are for JCA, understand the remaining gaps, share experiences and identify synergies across the member states on how to best address those. Based on Parexel’s observations of these discussions, there are varying levels of preparedness for this transition and member states are facing similar challenges for a successful implementation of the JCA framework. 

Readiness levels vary widely within the member states' assessments¹ 

The self-assessed readiness for adopting the new HTA regulation varies greatly among member states and European non-member states2, based on the insights shared within the panel sessions “From Theory to Practice” held by the European Commission from May 2023 onwards. (Figure 1) 

• Seven member states consider themselves ready and on schedule for the 2025 JCA shift, with minimal knowledge gaps, having been actively involved in European projects.  
  • Ready and on schedule: Czech Republic, Hungary, Ireland, Portugal, Netherlands, Slovakia and Spain  
• Sixteen member states have moderate confidence in their preparedness for JCA implementation. They have established in-market HTA decision-making processes and are familiar with the EUnetHTA21 policy. However, they require strengthening of local capacity, internal processes and expertise. 
  • Moderate in their preparedness for JCA implementation: Austria, Belgium, Bulgaria, Croatia, Denmark, Estonia, Finland, Greece, Italy, Latvia, Lithuania, Malta, Norway, Romania, Slovenia and Sweden  
• Four member states consider themselves not yet ready, lacking formalized local HTA processes and needing to establish an HTA regulation structure to ensure sustainable access.  
  • Not ready yet: Cyprus, Iceland, Luxembourg, and Poland 

All member states agree that JCA could potentially bring several opportunities 

• JCA offers an opportunity to align HTA evaluations with the regulatory processes and enhance collaboration among EU member states, potentially leading to more efficient and consistent assessment. 
• The implementation of JCA could foster knowledge sharing and capacity building, benefiting states with less experience in HTA or resource limitations. 
• A unified EU HTA framework presents the chance to develop standardized structures, processes, and IT platforms that could improve overall assessment quality and reduce duplication of efforts. 
• Member states may adapt the local guidelines to align with EU standards, integrating JCA with national processes thereby facilitating faster access to innovative medicines  
• Member states may consider legislative amendments to their national pricing and reimbursement systems. This may lead to changes in market entry requirements across EU members 
• Stakeholder involvement (clinicians, patients, payers, professionals) is likely to expand at national and European levels 
• JCA implementation may drive increased political awareness and support for HTA processes, potentially leading to greater resource allocation and optimization at national levels. 

Key challenges identified for the implementation of JCA are common between the member states 

• Harmonizing national HTA processes with the new EU framework poses a significant challenge, as states need to adapt their existing systems while maintaining alignment with local priorities and methodologies. 
• The tight timeline for implementing JCA-related changes creates pressure on states to rapidly modify their processes and corresponding legislation while developing new competencies before the 2025 deadline. 
• Defining the PICO (Population, Intervention, Comparator, Outcomes) framework is still uncertain, as criteria present a complex challenge in determining the scope and focus of assessments, in a timely manner. 
• Additionally, balancing national priorities with EU-level PICO and how to incorporate their perspectives into the overall assessment (e.g., having 27 different PICOS across all member states incorporated into the overall assessment) 

The main priorities that emerged from the discussions on JCA implementation across EU member states, focus on capacity building, harmonization, and stakeholder engagement, as follows (additionally, consult table 1 and table 2): 

• Strengthening cross-country collaborations and knowledge sharing on how to assess health technologies is crucial, especially to support states that are newer to HTA processes. 
• Enhance cooperation with relevant stakeholders, such as patient associations, professional societies, and payers to increase awareness of the process and establish the roles and responsibilities required from each side, to ensure that new pharmaceuticals are timely adopted considering multiple perspectives, especially for the MoH 
• Developing required skills and competencies on JCA guidelines is a top priority across all members and particularly for states with less experience in HTA. Mainly across the regulatory agencies. 
• Assessing and building administrative and scientific capacity at the national level is essential for states to effectively participate in and utilize JCA. 
• Harmonizing national HTA organizations and processes with the new EU framework, while balancing national priorities, is a critical challenge that needs to be addressed as earliest as possible. Mainly across the regulatory agencies. 
• Adopting and implementing the PICO framework at the local level is an important priority to align with JCA requirements, Across Regulatory and HTA bodies. 
• Establishing and implementing necessary infrastructure, processes, IT platforms and submission templates is a key focus, particularly for states with limited existing HTA infrastructure. 
• Securing political engagement and awareness for JCA implementation is vital to ensure necessary resources and legislative changes. 

As the JCA start date approaches, states must accelerate preparations to realize the full potential of this harmonized approach to HTA by addressing the current uncertainties and challenges associated with the complexity of the implementation process and inherent member states differences. While uncertainties remain regarding the tight timeline for adoption of the new framework into the member states existing systems, development of new competencies, and the characterization of the PICO frameworks, most states express commitment to making JCA work. A successful implementation will require continued guidance from the European Commission, political support at the national level, and a spirit of collaboration among all stakeholders.  

The JCA implementation presents significant challenges for EU Member States, including harmonizing processes and meeting timelines. However, it also offers opportunities for streamlined assessments, knowledge sharing, and standardized evaluation frameworks. Member States must prioritize cross-country collaborations, stakeholder cooperation, and aligning national HTA processes with EU frameworks.  

Pharmaceutical companies should prepare for potential changes in market entry requirements, possible changes in pricing and contracting expanded stakeholder engagement, and increased emphasis on value demonstration through robust evidence generation. For guidance to navigate this evolving HTA landscape effectively and to prepare for JCA milestones, please contact Parexel Access Consulting. We’re always available for a conversation.  

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