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The EU Joint Clinical Assessment (JCA) aims to streamline and improve the process of assessing the clinical benefits of health technologies across European Union (EU) member states. By fostering collaboration, the JCA ensures a more harmonized and efficient approach to Health Technology Assessment (HTA), helping to avoid duplication and increase the speed at which treatments are evaluated and made available to patients.

The PICO simulation (Population, Intervention, Comparator, Outcome) is a key component of this process, providing a structured framework for clinical evidence synthesis and decision-making allowing for more accurate and consistent evaluations of new treatments and medical technologies. The simulated PICOs will serve as an outline of the evidence generation plan and will serve as the outline for the JCA dossier. Including PICO strategy into the clinical trials set up, employing smart strategies like adaptive clinical trial designs and robust real-world evidence can be an effective instrument in addressing different member states' needs and overcoming regional barriers.

When compiling an effective JCA dossier, it is essential to focus on presenting clear, comprehensive, and high-quality evidence, considering the specific HTA requirements in each member state. Due to the large amount of data generated by PICOS, efficient and smart tools are needed to compile the information into the dossier in a time efficient manner. The JCA dossier will need to account for all populations, comparators and outcomes identified following the member state PICO surveys. This means that the dossier will need to include complete, up-to-date information including data, analyses (primary and ad hoc), SLR, ITC, and other relevant evidence aligning with PICOs.

The EU Joint Clinical Assessment (JCA) under the European Health Technology Assessment (HTA) Regulation aims to harmonize clinical assessments across EU member states. However, each country's HTA agencies and healthcare systems will react differently based on their national policies, reimbursement frameworks, and pricing strategies. Countries such as Germany, Italy, Spain, France, Norway, Poland, Ireland, Finland, UK and Switzerland will still have different focus depending on their country’s perspective and the question is what impact JCA process will have on the local reimbursement context.

In this webinar our experts will provide you with strategies, guidance and advice on managing JCA requirements in a constructive and efficient way including:

• Evidence generation and planning


• PICO mock-up and impact of PICOs in clinical trials


• JCA dossier information


• Impact of JCA on local HTA and reimbursement