EU Joint Clinical Assessment Readiness

How Patient-Centric Approaches Can Drive Market Access and Reimbursement Success

The European healthcare landscape is undergoing a significant transformation with the implementation of the EU Joint Clinical Assessment (JCA), a critical component of the EU Health Technology Assessment (HTA) Regulation. This new framework is already in effect for oncology and advanced therapies, with orphan drugs set to follow by 2028. The JCA aims to harmonize clinical assessments of health technologies across member states to ensure equitable and efficient patient access. For pharmaceutical companies with rare disease products, oncology portfolios, or both, the JCA presents both immediate and future challenges and opportunities, making patient engagement more crucial than ever.

Why Patient Engagement Matters in the JCA Era

With rare diseases affecting an estimated 30 million Europeans, patient voices are invaluable in shaping evidence generation, regulatory submissions, and market access strategies. The JCA framework places an increased emphasis on patient-relevant outcomes, underscoring the need for pharma companies to proactively involve patient communities in their clinical and commercial decision-making processes.

According to a study by the European Network for Health Technology Assessment (EUnetHTA), patient engagement has been shown to enhance the relevance of evidence submitted for HTA evaluations, increasing approval rates by up to 20%. Additionally, organisations such as EURORDIS, a non-profit alliance representing over 1,000 rare disease patient groups across Europe, emphasise the importance of transparent patient involvement to ensure that therapies meet real-world needs.

The Need for Urgent Action

The JCA is already in effect for oncology and advanced therapies, with orphan drugs set to be included by 2028. This staggered implementation demands immediate action to align development and market access strategies with the new framework to avoid:

• Misaligned Trial Designs: Trials not aligned with JCA requirements may face rejection or prolonged assessments.
• Extended Reimbursement Timelines: Missteps in dossier preparation could lead to delays in achieving market access.
• Competitive Disadvantage: Competitors who act swiftly will secure an edge in demonstrating readiness and value.
• Regulatory Scrutiny: Delayed planning could result in increased regulatory hurdles and additional evidence requirements, leading to unforeseen costs and resource allocation challenges.

Aligning Your Patient Engagement Strategy with JCA Requirements

To successfully align with JCA requirements, companies must:

• Incorporate PICO Framework Alignment: Ensure patient-relevant outcomes align with the Population, Intervention, Comparator, and Outcome criteria.
• Develop Robust Real-World Evidence (RWE): Collect meaningful patient data to support HTA submissions and demonstrate long-term value.
• Collaborate with Advocacy Groups: Leverage insights from patient organizations to strengthen clinical trial design and dossier submissions.
• Prepare Early Dossiers: Develop comprehensive, patient-focused submission packages that address evolving regulatory expectations.

Call to Action: Take the Next Steps

To tackle these challenges and make the most of patient engagement, now is the time to take action by:

1. Conducting a Gap Analysis: Evaluate current patient engagement efforts and identify areas for improvement.
2. Building Long-Term Relationships with Patient Organisations: Establish partnerships that provide ongoing insights and advocacy support.
3. Investing in Digital Patient Engagement Tools: Leverage technology to gather and analyse patient input efficiently.
4. Training Cross-Functional Teams: Ensure regulatory, commercial, and clinical teams understand and apply patient engagement best practices.
5. Monitoring JCA Developments: Stay ahead of regulatory changes to adapt strategies proactively.

How swii.ch Can Help

At swii.ch health, we bring over 20 years of experience in digital health and rare disease patient engagement. We specialise in:

• Helping you connect meaningfully with patient advocacy groups.
• Designing and implementing digital strategies that amplify patient voices.
• Training your teams to integrate patient insights effectively.
• Aligning your patient engagement strategy with JCA requirements.

Let’s Work Together

The EU JCA is more than a regulatory requirement—it’s an opportunity to put patients at the heart of drug development and market access.

Contact swii.ch health to assess your current patient engagement approach and develop a strategy that aligns with the evolving EU healthcare landscape.

Photo by Djim Loic on Unsplash