How an EU JCA Navigator with clear strategic implications and detailed process descriptions enabled global brand teams and Affiliates to prepare for the EU JCA

The challenge

Inbeeo’s client, a top 15 pharmaceutical company, is one of the first companies to go through the EU JC. It needs to prepare for EU JCA dossier submission by early 2025, amid many unknowns on what the EU JCA will look like in practice.

The global HEOR team in charge of leading the organization-wide EU JCA preparations and the product specific dossier submissions asked Inbeeo to:

• Develop a comprehensive playbook with EU JCA Strategic Guidance for brand teams to support their EU JCA journey.
• Monitor new insights related to the EU JCA implementation, for the development of the playbook, regular internal communications and EU JCA training materials.

The approach

Inbeeo developed a 15-month program to support the client and the brand teams, via four workstreams running in parallel:

1. Processes

Development of overview timelines, flowcharts and activity sheets outlining strategic considerations, steps, decisions, activities and interactions for EU JCA dossier submission per function/team

2. Insights Gathering

Monitoring of internal and external sources of information and identification and answering of questions and uncertainties on a rolling basis

3. Communication & Training

Development of regular newsletters & a training plan and materials meeting the needs of the various internal stakeholders

4. EU JCA Playbook

Development of a comprehensive playbook to bring all information together

The impact

By working with the Global HEOR team, their counterparts in e.g., Biostatistics, Regulatory, Access, as well as brand team leads, affiliates, and the senior leadership team, Inbeeo is currently contributing to:

• Scenario planning in terms of future evidence generation resourcing needs
• A shared understanding of the EU JCA and the implications for company processes throughout the product lifecycle
• A detailed breakdown of the who, what, why, when and how in relation to EU JCA dossier submission
• A company-wide feeling of EU JCA readiness in terms of ability to navigate the challenges and opportunities brought by the EU JCA