In January 2022, a significant milestone was reached in the field of Health Technology Assessment (HTA) with the enforcement of the EU-HTA regulation. This regulation aims to harmonize the HTA process across the EU and improve efficiency by reducing duplication of efforts for national HTA authorities. Replacing the existing voluntary network of national HTA agencies and the EU-funded Joint Actions (EUnetHTA), the EU-HTA regulation introduces a permanent framework for collaborative work. To this end, it covers horizon scanning, joint scientific consultations, joint clinical assessments, and voluntary cooperation on non-clinical aspects of HTA which remains a national responsibility. From 2025 onwards, the regulation will be gradually implemented, starting with cancer treatments and advanced therapy medicinal products (ATMPs), followed by orphan drugs in 2028 and all other drugs in 2030. In this interactive course, we will discuss the methodological deliverables, procedural guidelines and templates produced by EUnetHTA 21, a consortium of EU-HTA agencies in charge of the key deliverables. We will focus on the latest developments around the joint clinical assessment, aiming to produce one single assessment of the relative clinical benefit of the new drug that is the basis for all EU member states. This assessment starts with a survey among the member states asking for the patient/population, intervention, comparison and outcomes (PICOs) they need. The course will also address the challenges associated with the position of the joint clinical assessment alongside the EMA assessment and the national market access processes, and the involvement of manufacturers and patient representatives.

In the final segment of this course, we will examine the potential implications and future prospects of the EU-HTA regulation. We will discuss how this regulation could potentially reshape the landscape of HTA in the EU, and what this means for stakeholders, including healthcare providers, patients, and pharmaceutical companies. We will also consider the potential challenges and opportunities that may arise as the regulation is progressively implemented. This will include a discussion on how to navigate the transition period and how to prepare for the full implementation of the regulation.

To ensure a practical understanding of these concepts, we will divide the classroom into smaller groups for a portion of the course. These groups will work on a practical exercise involving a hypothetical cell or gene therapy, using evidence from single-arm studies. By the end of this course, participants will have gained a comprehensive understanding of the EU-HTA regulation and will be equipped with the knowledge and tools to navigate this new era of health technology assessment in the EU. Join us as we unravel the complexities of the EU-HTA regulation and its impact on the future of HTA in the EU.

PREREQUISTE: Participants who wish to gain hands-on experience are required to bring their laptops.