PURPOSE: To contribute to a sustainable and transparent legal EU HTA framework.

DESCRIPTION: The affordability of newly approved innovative health technologies (IHTs) poses a challenge for many health systems in the European Union (EU). To ensure quick patient access to these technologies, health care payers and pharmaceutical companies have explored various ways of defining payment for new products. However, the negotiation process between companies and individual countries has resulted in significant price discrepancies and unequal patient access. To address this issue, the EUnetHTA 2021 initiative has made progress in jointly assessing the clinical aspects of IHTs starting from 2025. Nonetheless, Member States still retain the responsibility of evaluating the added value of these technologies to their respective health systems. To establish a sustainable and transparent legal EU Health Technology Assessment (HTA) framework, the ASCERTAIN project aims to develop new models for pricing, cost-effectiveness, and reimbursement.

In this workshop, Mirjana Huic will provide an overview of the EU HTA regulation, its main objectives, key principles, governance structure, areas of joint work, and the role ASCERTAIN can play in supporting it. Isabelle Durand-Zaleski will then discuss the differences between countries using price and reimbursement as negotiation variables, along with the use of clinical effectiveness data for value-based purchasing. Nicolas Xander will elaborate on the development of new models within the ASCERTAIN project and addressing legal and sustainability issues.

The workshop will conclude with an interactive question and answer session aimed at fostering cooperation between Member States and gathering input for the ASCERTAIN project. Policy makers, healthcare professionals, patients, academia, and health technology developers are encouraged to attend. The speakers will engage the audience by soliciting public comments and conducting real-time polling to gather immediate feedback and insights. Active participation is expected to gather diverse perspectives and experiences in expanding the HTA framework.