P17 Can You Design and Conduct a Real-World Evidence Study That Is Transferable Between HTA Bodies?

Abstract

Health technology assessment (HTA) bodies increasingly acknowledge the value of real-world evidence (RWE) for decision-making, with the UK’s National Institute for Health and Care Excellence (NICE) and the French Haute Autorité de Santé (HAS) having formalised their requirements. Alignment of HTA body RWE guidelines is key to designing studies that are transferable between countries in specific cases, such as rare diseases. This study reviewed RWE guidelines from NICE and HAS to assess the feasibility of conducting a single RWE study acceptable to both HTA bodies.