As Europe shifts to a PICO-centric model, redefining your Real-World Data (RWD) strategy is no longer optional.
It’s essential for market access. The landscape of European Health Technology Assessment (HTA) is evolving. Emerging insights from early Joint Clinical Assessments (JCAs) have made one thing abundantly clear: evidence confidence depends entirely on comparator readiness.
If you are relying on traditional evidence generation, you may be falling behind. This shift is particularly critical for programs where randomized comparator data is historically limited, such as in oncology, rare diseases, and single-arm development trials.
Manufacturers must rethink how and when they build comparative evidence to ensure successful HTA submissions.
Explore:
- Navigating the PICO-centric Shift: Understand how the evolving European HTA process changes the requirements for comparative evidence.
- Overcoming Data Limitations: Strategies to build robust evidence packages for oncology, rare disease, and single-arm programs. RWD as an Enterprise Asset: Why comparator-ready European RWD must transition from a standard HEOR investment to a strategic, enterprise-wide priority.
Read the full insights from industry experts Chris Cameron, Femida Gwadry-Sridhar, and Nicole Ferko.
Author
Dr. Chris Cameron is a global thought leader in health economics and outcomes research with over a decade of experience. Prior to joining EVERSANA, Chris was a partner at Cornerstone Research Group Inc., and…
Nicole directs U.S. and global projects to support multi-stakeholder medical device adoption and reimbursement. Nicole has more than 20 years of experience in health economics and research methods within academic, industry, and consulting roles.…