ISSUE: The European Union (EU) Health Technology Assessment Regulation (HTAR) will be applied from January 2025. From that date, all advanced therapy medicinal products and medical devices will have their relative clinical efficacy evaluated through a new EU Joint Clinical Assessment (JCA) pathway. Indirect treatment comparisons (ITCs) are expected to be frequently required to address the numerous PICOs (Population, Intervention, Comparator, Outcomes) requested in the JCA scope.

OVERVIEW: Member states will request relevant policy-driven PICOs to be consolidated and shared with the Health Technology Developer. Ideally, PICOs would be assessed using randomized head-to-head evidence, which is often impossible, as standards of practice vary from country to country, making ITCs essential. However, contextual data limitations are likely to be present in most ITCs. Additionally, substantial resources are required from all stakeholders to conduct and assess the necessary ITCs, either due to the number of PICOs requested or the number of ITCs considered necessary to address each PICO. The panelists will provide an overview of available HTA ITC guidelines and previous experience with EUnetHTA relative effectiveness assessments. They will highlight the rationale behind the design of joint clinical assessments and discuss how member states will likely handle various ITC methods. The panel will summarize the expected opportunities and challenges, from their respective and diverse viewpoints, in using ITCs to assess the relative clinical effectiveness for different stakeholders. Sophie Van Beekhuizen will moderate the issue panel. Wim G. Goettsch will offer a broader HTA perspective, addressing EU and national issues on the JCA process and its implications. Mahmoud Hashim will present a Health Technology Developer's viewpoint on how to be well-prepared for multiple PICOs & ITCs within the EU JCA. Finally, from an industry perspective, Thomas Wilke will outline the long-term and short-term activities required to successfully deal with the future JCA challenges.