The 3x3 of Patient Engagement in the JCA - Unlocking Value through Early Involvement

Despite criticism of the current scope and format of patient participation in JCA, its underscores the growing importance of the patient voice in EU HTA.Consequently, skillful patient engagement is key to ensure that the patient voice is included appropriately. However, integrating patient voices effectively requires understanding of the relevance of patient experience data and the evolving role of patient advocates.

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3 Roles of Patients in JCA

Patients contribute to three key phases of JCA. Caveat: only, if requested by assessors. Patients cannot volunteer insights without invitation:

• Assessment Scope: Input on PICOs.
• Draft JCA and Summary Reports: Feedback on methodology and outcomes.
• JCA Updates: Involvement in revisions when new evidence emerges.

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3 Arguments Why Early Engagement Matters

1. Value Generation: Timely generation of patient-relevant data remains the cornerstone of good HTA. What is missed in value generation cannot be made up in value communication, so early patient engagement is key to identify patients’ needs and preferences. Patient preference information can shape endpoint selection and justify patient relevance.
2. Value Communication: Early input ensures evidence aligns with patient priorities, strengthening HTA submissions. Patient preference information, when applied in a timely manner with a sound methodology, can help focus HTA reviewers on the most critical and patient-relevant aspects of the value narrative.
3. Avoiding "Last-Minute" Pitfalls: Late involvement risks missing opportunities to gather real-world data that matters or patient preference information.

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3 Recommendations for Effective Collaboration

1. Integrate Patients Early: Engage patient experts during Phase II trials to co-design protocols. It will not only support your HTA procedure but also provide an opportunity to enhance recruitment and retention in your trial.
2. Invest in Training: Leverage HTA courses, such as EUCAPA, to empower patient advocates. Many organizations lack resources to prepare for JCA-specific roles and patients within the JCA procedure act in individual capacity.
3. Navigate COI Policies: Please be mindful of the sensitivity of COI. If no suitable patient expert without a COI is available, the Commission may grant an exception to this rule.

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Conclusion

Early and meaningful patient engagement is essential for a successful JCA process. Involving patients at an early stage improves evidence generation, ensures that HTA submissions reflect real patient needs, and aligns value communication with patient priorities. To maximize impact, early collaboration, targeted training, and consideration of COI policies are key to unlocking the full value of patient involvement in JCA.

We are happy to help you involving the patient voice within the new wayo f HTA in the EU. Finding the right overarching JCA strategy, our partner, Justin Stindt Consultants can be of help, too.

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