Preparing for Joint Clinical Assessments (JCAs): What You Need to Know

Because the EU Health Technology Assessment (HTA) regulation will take effect in January 2025, pharmaceutical and medical device companies must prepare for a new era in health technology evaluations. The Joint Clinical Assessment (JCA), a core feature of the regulation (EU 2021/2282), promises a more streamlined, harmonized assessment process across Europe, particularly benefiting companies aiming to launch innovative therapies across multiple EU markets. However, being JCA-ready comes with its own set of challenges and opportunities.

What Is the JCA and Why Does It Matter?

The JCA will consolidate clinical assessments of health technologies (including oncology drugs, advanced therapies and orphan drugs) at the EU level, meaning companies need to submit data only once for all member states. This reduces duplication, allowing companies to focus on generating high-quality evidence and bringing innovative products to market faster

From a strategic perspective, the JCA process helps to address differing HTA requirements across member states, making the path to reimbursement more predictable. For companies with highly innovative or niche therapies, this harmonization can open doors to broader, faster patient access, but it also places a premium on thorough preparation.

What Companies Need to Do to Prepare:

1. Develop a proactive evidence strategy: Start preparing early. A typical JCA dossier includes a range of data, from patient population and clinical outcomes to regulatory status and supporting studies. Companies need to predict and address the PICO (population, intervention, comparator, outcome) criteria of multiple countries to avoid delays.
2. Ensure collaboration and alignment: Aligning teams across market access, regulatory affairs and evidence generation is key to avoiding bottlenecks. An integrated strategy that anticipates the various subpopulations and comparators expected by different national agencies will aid in navigating the complexities.
3. Leverage AI and data integration: Dashboards such as NAVLIN by EVERSANA’s PICO planner are designed to help companies manage these challenges efficiently. With real-time updates on HTA data across more than 40 bodies, AI-assisted navigation and consulting support, this dashboard ensures your evidence strategy is not only prepared but also optimized for the evolving landscape. By streamlining data gathering, analysis and consultation, it helps companies stay ahead of the JCA process.

Opportunities Ahead

The JCA not only harmonizes processes, but also paves the way for faster access to new therapies, particularly in oncology, ATMPs and orphan drugs. Companies that invest in proactive dossier development and collaborative PICO scoping will be best positioned to capitalize on the new system. By planning early and using tools like the PICO planner, companies can turn this regulatory shift into an opportunity for growth.

Because JCA readiness is critical for market success, now is the time to assess your processes, align your teams and integrate smart solutions that will keep you ahead in this evolving HTA landscape.

To learn more about EVERSANA’s pricing and market access services and solutions, visit navlin.com