What's Happening?
The European Union has introduced the Health Technology Assessment Regulation (HTAR), effective January 2025, which includes the Joint Clinical Assessment (JCA) to harmonize clinical evaluations across member states. Dr. Pamela Vo, VP of HEOR and Value & Evidence at EVERSANA, emphasizes the importance of early strategic planning and cross-functional collaboration for pharmaceutical companies navigating this new landscape. The JCA mirrors the European Medicines Agency's centralized approach, requiring companies to coordinate across regulatory, clinical, HEOR, and market access teams. Despite its harmonization goals, national-level integration of JCA findings remains uncertain, posing challenges for market access and reimbursement.
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Why It's Important?
The JCA represents a significant shift in the EU's health technology regulation, aiming to streamline clinical assessments and reduce duplication of work. This new process elevates the importance of evidence-based assessments for market access and reimbursement, requiring companies to demonstrate cost-effectiveness or additional benefits of their products. The focus on oncology and advanced therapy medicinal products (ATMPs) presents unique challenges, particularly in rare diseases where robust trials are difficult. The JCA's success could lead to faster access to innovative treatments across Europe, impacting pharmaceutical strategies and patient outcomes.
What's Next?
Pharmaceutical companies must adapt to the JCA's requirements, including early planning and evidence generation aligned with the PICO framework. The integration of JCA findings into national reimbursement processes remains uncertain, with some countries modifying their procedures. The JCA's initial focus on oncology and ATMPs will test the new regulation, potentially influencing pricing and reimbursement decisions. Companies may seek early advice through the Joint Scientific Consultation to align clinical development with HTA expectations, enhancing their chances of successful market access.
Beyond the Headlines
The JCA introduces methodological challenges and data availability issues, particularly for therapies relying on single-arm trials. The process requires companies to manage both EU-level and national dossiers, potentially adding complexity rather than reducing it. The JCA's focus on evidence generation and the PICO framework highlights the importance of transparency and methodological rigor in indirect treatment comparisons. As companies navigate this new landscape, strategic planning and cross-functional collaboration will be crucial for success, offering a roadmap for delivering transformative treatments to patients across Europe.
