A leading global pharma company was preparing for the EU Joint Clinical Assessment (JCA) to secure market access for a new therapy.
It faced three key challenges: identifying payer and non-payer stakeholders expected to inform and complete the PICO survey, conducting a PICO simulation, and developing an EU JCA value story and engagement strategy.
To navigate this complex process, the company needed to align its global, regional, and local teams to meet the EU JCA’s demands effectively.
We started by designing a multi-faceted approach to address the intricacies of the EU JCA process.
Our team mapped the EU JCA workflow, from EMA marketing authorization submission as the starting point of the process, to the publication of the JCA report, while detailing requirements, timelines, and engagement opportunities. We identified key stakeholders across six priority markets to optimize engagement, focusing on those likely to complete the PICO survey and provide strategic insights.
Then we identified and prioritized potential PICOs for the new therapy, incorporating affiliates’ feedback, and developed a strong value story addressing clinical and payer concerns. Finally, we crafted a stakeholder engagement strategy to enable the global pharma company to inform payer selection of clinically appropriate PICOs aligned with the therapy’s strengths.
We ensured the client was ready for undergoing the EU JCA process for the new therapy, aligning teams on key requirements, roles, and responsibilities.
By testing the access and evidence development strategy against the EU JCA requirements, we refined evidence to support the prioritized set of PICOs. Additionally, we developed a compelling value story, matching both the global value dossier and JCA dossier for the product, and engagement strategy, empowering local teams to execute targeted outreach effectively.
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