Presentation (CTI)

OBJECTIVES: Starting in 2025, Health Technology Developers (HTDs) introducing new cancer treatments and advanced therapies in Europe must navigate the Joint Clinical Assessment (JCA). JCA implementation presents several challenges, including multi-PICO scoping, early dossier preparation, intensified internal competition for study design, and the need to balance EU and national evidence requirements. This research aims to explore the implications of JCA on HTDs' strategic planning and present a structured approach to optimize evidence generation and streamline JCA submissions.
METHODS: A structured analysis was undertaken to identify key challenges and best practices for HTDs in preparing for JCA. This included a critical review of EU HTA regulations, implementing acts, and methodological guidance. Additionally, qualitative insights were gathered through multi-stakeholder consultations and expert discussions, focusing on aligning evidence generation strategies with JCA requirements. Strategic approaches were synthesized to support HTDs in integrating JCA needs into development plans.
RESULTS: Two complementary strategic approaches emerged. First, a proactive strategy involves early engagement—ideally before pivotal study design—to optimize generation of direct comparative evidence aligned with anticipated PICO requirements. Second, a mitigation strategy focuses on maximizing the value of existing data through robust indirect treatment comparisons and systematic literature reviews when early alignment is not feasible. Both strategies emphasize the importance of anticipating and consolidating PICO elements to address both JCA and national HTA requirements effectively. A structured process for early PICO scoping—encompassing prediction, consolidation, and prioritization—was identified as a critical enabler of successful evidence generation and submission planning.
CONCLUSIONS: HTDs can enhance their preparedness for JCA by adopting a structured, flexible approach that integrates early anticipation of regulatory expectations and fosters cross-functional collaboration. Proactive planning for direct and indirect evidence generation, coupled with systematic PICO alignment, will be key to streamlining submissions and securing timely market access in the evolving European HTA landscape.