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Introducing the Joint Clinical Assessment (JCA) in the EU: Aiming to Enhance Access to Innovative Therapies but Risking to Duplicate HTA for the Industry

The Joint Clinical Assessment (JCA) process in the European Union marks a significant advancement in the evaluation of innovative therapies across member states. The primary goal of JCA is to streamline and harmonize the assessment of new treatments, aiming to optimize patient access to cutting-edge medicines while ensuring cost-effectiveness and patient safety. However, due to the uncertainty surrounding several specificities of the process and its imminent implementation, industry concerns have surfaced, suggesting a potential risk of duplicating efforts on both the EU and national levels.

How JCA Works

JCA involves collaboration among various national health technology assessment (HTA) bodies and experts from different EU countries. These experts jointly evaluate the clinical data and evidence supporting a particular therapy. By pooling resources and expertise, JCA should offer an efficient approach to assess the clinical and economic value of innovative treatments. This process is hoped to reduce redundant evaluations, speed up decision-making, and promote consistent standards across member states.

Challenges of the JCA

While the JCA process could offer significant advantages, it is not without challenges. Diverse healthcare systems, treatment priorities, and patient populations among EU member states require robust communication and cooperation among participating countries. Harmonizing criteria and aligning evaluation methods can be complex, necessitating open dialogue and consensus-building during the assessment. For example, a significant hurdle lies in achieving alignment on the PICOs (Population, Intervention, Comparator(s), Outcome(s)), as member states may hold diverse expectations based on their healthcare systems and the range of available comparators, among other factors.

It is also becoming apparent that the JCA process presents new challenges for both small and large pharmaceutical and biotech companies. For small companies, navigating multiple national health technology assessments can be resource-intensive, but JCA should offer a chance to streamline submissions and reach a wider patient base. However, they may not have the resources needed to adapt to the new process and there is no guarantee that national level HTA and price negotiations will be more straightforward following JCA. Larger companies with more extensive pipelines may be able to leverage learnings from prior JCAs for their subsequent assets but often see JCA as driving a requirement to build a dedicated team focused on JCA on an above-country level in addition to local Market Access teams.

The Future of JCA

As of January 2024, all methodologies for the JCA process were planned to be finalized and ready for implementation but the publication seems to be delayed. The process aims to ensure transparency, consistency, and quality in the evaluation of innovative therapies. It will continue to evolve and adapt to the changing landscape of healthcare and medical advancements.

In conclusion, JCA holds promise for streamlining evaluation processes, requiring adaptability and cooperation from both industry and regulatory bodies. Its goal is to enhance patient access to groundbreaking treatments and influence the future of healthcare in the EU. All eyes are now on the EU and HTACG to address remaining unanswered questions and gaps and thus reassure big and small pharma and biotech firms that the benefit of JCA exists. Until all details on the process are unveiled, significant uncertainty persists and concerns of a duplication of HTA processes on EU and member state level. For more information on the JCA process and its impact, stay tuned for updates from relevant EU authorities and Justin Stindt Consultants.

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