Presentation (CTI)

OBJECTIVES: With the increasing utilization of real-world evidence (RWE), health technology assessment (HTA) bodies are recognizing its importance in the evaluation of new technologies. However, there are several challenges in integrating RWE into the HTA process, including the ambiguity of HTA guidelines. Therefore, we selected eight countries to obtain the most recent HTA guidelines from a global perspective and identify unmet needs.
METHODS: We reviewed HTA guidance documents and grey literature discussing the position towards RWE of eight countries: France, United Kingdom (UK), Italy, Germany, Sweden, Canada, Brazil, and South Korea. We then extracted and summarized their opinions and recommendations.
RESULTS: Of the eight HTA bodies, only four had published guidelines on the use of RWE: France, the UK, Canada, and Brazil. In general, these advise that RWE populations analyzed should be relevant to the target indication, data should be fit-for-purpose, and sensitivity analyses should be used to assess the robustness of studies, among many others. HTA bodies in Italy, Germany, Sweden, and South Korea did not have published guidelines, although they appear to accept RWE studies in certain cases. A survey of 22 European HTA bodies found that 82% wish to see structured use of RWE in assessments. Previous reviews of HTA submissions have also identified an increased use of RWE, growing 33% from 2011 to 2021.
CONCLUSIONS: The integration of RWE into HTA evaluation represents a significant evolution in how healthcare technologies are evaluated. While progress has been made globally to establish guidelines and frameworks for using RWE, ongoing efforts are needed to address existing challenges related to data quality, regulatory acceptance, and stakeholder engagement. Enhanced collaboration among industry players and regulatory bodies will be crucial in optimizing the use of RWE to support informed decision-making in healthcare.