EU HTA Regulation: Ready for 2025 EU Joint Clinical Assessment (JCA)

ISSUE:

The EU HTA Regulation (EU 2021/2282) represents a significant shift in how new health technologies are evaluated and accessed across Europe. Implemented in January 2022, the regulation comes into full effect in January 2025. While regulatory decisions are centralized in the EU, most countries have their own Health Technology Assessment (HTA) process. HTA methods and processes vary by country leading to differences in ratings, access to medicines and delay in time for patients in the EU. The HTA Regulation aims to improve and accelerate patients’ access to new health technologies in the EU by harmonizing clinical assessment across Member States.

As the EU HTA Joint Clinical Assessment (JCA) will parallel the review and approval process by Regulators, time for preparation of both dossiers, review and decision making and alignment with following national reimbursement are anticipated to provide new challenges for the involved stakeholders. It can also be anticipated that interference of the content discussion cannot be avoided as data analysis will continue during the review phase.

This panel discussion will dive into how the implementation of this process may impact drug development for Europe in general in future, (e.g impact on Scientific Advice procedures, on development program design and on outcome of the reviews) and underline the key elements which need to be put in place to ensure a speedy, future-proof preparedness from both sponsors, but also health authorities.

OVERVIEW: Timeframe 45 min: moderator and panelists introducing their perspective in a motivational speech (5 minutes each), 15 minutes discussion on selected topics and 10 minutes on questions from auditorium