EU HTA Implementation: Learnings From The First Year

By Ruairi O'Donnell, PhD

The EU Health Technology Assessment regulation's first year has revealed important patterns for manufacturers preparing joint clinical assessments. PICO consolidation remains complex, requiring careful alignment between evidence generation and assessment frameworks across 27 member states. Resource constraints affect both HTA bodies and industry participants, particularly smaller companies managing increased workloads.

However, opportunities exist through early Joint Scientific Consultations, which allow manufacturers to align evidence strategies before pivotal trials begin. Patient engagement during PICO definition stages ensures products address real-world needs. Success depends on transparent communication, formalized industry consultation during scoping, and member states effectively using JCA reports to streamline national reimbursement decisions. Manufacturers who engage proactively with evolving requirements and prioritize stakeholder collaboration will be better positioned for efficient assessments.