Regulation (EU) 2021/2282, published in December 2021, aims to harmonize health technology assessment (HTA) across the European Union by launching the EU-wide Joint Clinical Assessment (JCA). As more information emerges on JCA methods, the direction of travel appears to be towards accepting only gold-standard evidence such as randomized clinical trials (RCTs), even when these may not be feasible for ethical or practical reasons. This could create challenges for some health technologies, such as highly innovative treatments, to meet JCA evidence requirements.

In this presentation, Suzette will provide an overview of the new EU regulation and the potential challenges we envisage based on the draft guideline documents published to date. Miranda will then explore the issues relating to indirect treatment comparisons, particularly in the context of a high number of comparators, before James highlights a potential role for structured expert elicitation in filling evidence gaps where the collection of empirical evidence is unfeasible. We will conclude by highlighting the risks of setting the bar too high for evidence generation, particularly for innovative technologies and rare diseases.

Learning objectives:

• Understand the current direction of travel for EU JCA and its possible implications
• Dissect the challenges and risks posed by the current evidence requirements for JCA
• Highlight the value of alternative methodologies where gold-standard evidence is unattainable