The Joint Clinical Assessment (JCA) is a new mandatory evaluation process for new medicines within the European Union. It aims to provide a streamlined assessment of new drugs' safety and effectiveness across all EU member states. This assessment will occur in parallel with the European Medicines Agency (EMA) marketing authorization process. While the JCA is not legally binding, EU member states are expected to consider its findings in their national decision-making processes. The rollout will begin in January 2025 with oncology drugs and Advanced Therapy Medicinal Products (ATMPs), followed by orphan drugs in 2028, and by 2030, all new medicines will be included within this framework.
There are two primary challenges with the JCA. First, the impact of the JCA will vary among member states. Countries with fewer resources for conducting Health Technology Assessments (HTAs) may find the JCA more impactful, while those with established HTA pathways and differing national HTA requirements may experience less impact. This variation means that both the JCA and country-specific requirements must be considered in launch strategies, potentially adding complexity.
Second, the tight timelines pose a significant challenge. The scope of the JCA assessment is defined through PICOs (Population, Intervention, Comparator, Outcomes) development, which consolidates diverse needs from all member states into several PICOs. Once these PICOs are communicated to pharmaceutical companies, they have only 100 days to submit the JCA dossier. This deadline is especially challenging given the need to conduct systematic literature reviews (SLRs) on all the PICOs.
Amanda Hansson Hedblom is a Manager at FIECON, specialising in high-quality HEOR and Access solutions. With rich experience in HEOR and Market Access consulting, Amanda excels in Nordic HTA submissions, medical device research, and Market Access strategy. Recently, she led the development of FIECON's AI-driven systematic literature review workflow, showcasing her commitment to innovation and excellence in health economics research.
