The Center for Innovation in Regulatory Science (CIRS) makes recommendations on ensuring efficient and effective implementation of the Joint Clinical Assessment at the national level

On June 14, 2024, in Seville, Spain, the Center for Innovation in Regulatory Science (CIRS) brought together senior representatives from HTA agencies, pharmaceutical companies, payers, and patient organizations to discuss their readiness for the EU HTA Regulation being applied in January 2025. The aim was to make recommendations on ensuring efficient and effective implementation of the JCA (Joint Clinical Assessment) at the national level and to identify metrics that will enable iterative learning among stakeholders.

Highlights from the workshop are listed below:

• Agencies are adapting but must remain flexible
  • HTA agencies are preparing for JCA implementation by engaging in activities like horizon scanning, assessor workshops, training, and updating internal systems such as IT platforms. From 2025 to 2030, they plan to run both JCA and non-JCA processes in parallel, with flexibility being essential for integrating changes based on continuous learning into JCA.
• Short-term efforts for long-term gains
  • Capacity for JCA implementation is a key issue for both companies and agencies. For many agencies, resources are already limited and there can be difficulties recruiting the right experts. Companies are concerned about the additional internal workload, as evidence to satisfy all EU HTA processes is needed earlier, with an additional dossier developed in parallel to the regulatory filing. Teams such as Biostatistics/Data Science and Market Access are anticipated to be impacted the most. Nevertheless, there is shared hope that in the long run, JCA will reduce duplication and save resources for both companies and agencies, ultimately accelerating access to innovative therapies for EU patients. 
• Companies feel relatively ready but are concerned with uncertainty around JCA
  • Both companies and agencies are facing capacity challenges in implementing JCA, with agencies struggling to recruit the necessary experts and companies concerned about the additional internal workload.
• Stakeholder communication is key
  • Proactive communication and engagement with stakeholders, including industry associations, healthcare providers, patient organizations, and payers, have been central to agencies' HTAR preparations. However, there is a need for better communication about the varying impact of the JCA report across countries to manage expectations, and a "safe harbour" discussion in 2025 would be beneficial for stakeholders to share early experiences and insights on JCA.
• Uncertainty over patient involvement
  • There is uncertainty about when and how patients and patient organizations will be involved in the JCA process, and clarification is needed to ensure predictable and meaningful contributions. Given the variation in staffing, resources, and expertise among national patient organizations, these factors must be considered if scientifically based input, such as patient experience data for informing PICOs, is required. Clear communication, transparency, and ongoing evaluation are essential to effectively shape patient involvement in JCAs.

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