The European Union’s new Joint Clinical Assessment (JCA) framework is set to revolutionize market access, but it also introduces a new layer of complexity.
With a single clinical assessment informing reimbursement decisions across all member states, the stakes have never been higher for health technology developers. Misaligning evidence packages with the final PICO (Population, Intervention, Comparator, Outcomes) requirements can lead to costly rework and significant delays.
The question: How can you navigate this uncertainty and ensure a successful launch? Anticipating the right PICO is now a critical early-stage activity, not a post-regulatory task.
In ISPOR’s Value & Outcomes Spotlight feature, EVERSANA experts Pamela Vo and Shivani Shah, alongside industry experts, explore the strengths and limitations of various PICO prediction strategies. From traditional literature reviews to advanced AI-powered tools.
Discover why a blended, tailored approach is the most effective path forward and learn key lessons from the first year of JCA implementation to refine your evidence generation strategy.
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Author
With 20+ years of HEOR experience in the pharma industry, Pamela has a demonstrated history of strategically turning ideas into impactful results with a proven track record of 30+ peer-reviewed publications, substantial market access…
Shivani Shah is Senior Consultant at EVERSANA and has around 6 years of experience working as consultant in pharmaceutical and life-science industry. Prior to joining EVERSANA, she has worked at one of the top…