EMA vs. JCA vs. HTA: Navigating Evidence Requirements and Simultaneous Interactions

With the introduction of JCA, Europe will see changes in the reimbursement evaluation landscape. Addressing evidentiary needs across EMA, JCA and HTA agencies will require the implementation of an integrated evidence generation planning (IEGP) approach to address each reimbursement scenario without utilizing learnings from a sequential launch strategy. With a promise of accelerated approvals and faster patient access, how will national HTA bodies evaluate new treatments post-JCA? How can health technology developers (HTDs) prepare for simultaneous launches across Europe without the benefit of sequential market learning? In this session, we discuss how trial designs, clinical development programs and RWE strategies will need to be adapted; what those evidentiary needs look like and how HTDs can (and should) be integrating these insights into evidence generation strategies throughout the product development lifecycle. The presentation will explore how national HTA bodies may utilize the JCA evaluation, adaptations to the core clinical package to support clinical value and evidence requirements to support national economic value demonstration. Key topics include: 1. With transparent data sharing, will JCA end HTA divergence? 2. How HTA agencies will handle evidence transferability 3. The role of external stakeholder engagement in building comprehensive market access strategies

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