Joint Clinical Assessments in Europe: Implications for Market Access, Reimbursement, and National HTA Alignment.

The Joint Clinical Assessment is a crucial development under the European Union Health Technology Assessment Regulation (EU HTAR, 2021/2282), aimed at standardizing clinical assessments across the Member States. This review explores the opportunities, challenges, and future actions for Joint Clinical Assessment implementation, particularly emphasizing methodological, regulatory, and stakeholder considerations. With the evolution of the European healthcare landscape from decentralized health technology assessment processes to a more streamlined framework, the Joint Clinical Assessment aims to enhance efficiency, reduce duplication, and expedite patient access to novel therapies while maintaining national reimbursement autonomy. Central to the Joint Clinical Assessment is the Patients, Interventions, Comparator, Outcomes (PICO) framework, which guides evidence generation but varies across countries, creating uncertainty and requiring early transparent agreement. Challenges to Joint Clinical Assessment implementation include tight timelines, misalignment with national processes, autonomy of national health technology assessment agencies over reimbursement, and the uncertainty about real-world evidence, specifically for oncology and rare diseases. Orphan drugs, gene therapies, and vaccines present unique concerns owing to smaller patient populations, limited data from clinical trials, or ethical restrictions in conducting randomized controlled trials. These concerns can be overcome with scientifically robust alternatives, such as adaptive assessment approaches enabling staged assessments and updates with evolving data. Early patient involvement through advisory panels, surveys, and feedback loops in processes, such as scoping, assessment, and evidence-generation phases can improve transparency and integration of patient preferences while reflecting real-world treatment needs in clinical evaluations. The long-term success of the Joint Clinical Assessment will depend on both standardisation and flexibility, supported by stakeholder collaboration and robust methodological guidance.