Harmonizing Health Technology Assessment: PICO Consolidation Under The EU HTA Regulation

The implementation of the EU Health Technology Assessment Regulation (EU HTAR) marks a fundamental shift in how life sciences companies must approach clinical evidence. In this discussion, Ruairi O’Donnell, a veteran in market access and HEOR, joins Dr. Patti Peeples to break down the complexities of PICO consolidation. They move beyond the theory of the Joint Clinical Assessment to address the practical friction between European harmonization and national sovereignty.

The conversation offers a deep dive into managing unrealistic comparator demands and the strategic integration of real-world evidence to bridge data gaps. By examining lessons from early oncology and ATMP submissions, this interview provides the foresight needed to adapt evidence-generation strategies before regulatory disruptions impact your portfolio. View the full interview to refine your approach to these evolving requirements.