Integration of real-world evidence from different data sources in health technology assessment

Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in the therapeutic product lifecycle but remains underutilized in the health technology assessment (HTA) process. RWE aims to fill the current evidence gaps, reduce the uncertainty around the benefits of medical technologies, and better understand the long-term impact of health technologies in real-world conditions. Despite the minimal use of RWE in some elements of HTA, there has been a larger push to further utilize RWE in the HTA processes. HTA bodies, as other stakeholders, work towards developing more robust means to leverage RWE from various data sources in the HTA processes. However, these agencies need to overcome important challenges before the broader incorporation of RWE into their routine practice. This paper aims to explore the extensive integration of RWE utilizing diverse sources of RWD. We discuss the utilization of RWE in HTA processes, considering aspects such as when, where, and how RWE can be effectively applied. Additionally, we seek the potential challenges and barriers associated with the utilization of different data sources.

Automated summary

Real-world evidence (RWE) is increasingly used in the therapeutic product lifecycle, but its utilization in health technology assessment (HTA) remains limited. This paper explores the integration of RWE from diverse sources to fill evidence gaps and improve understanding of the long-term impact of health technologies in real-world conditions. Despite challenges, HTA bodies and stakeholders are working towards effectively utilizing RWE in the HTA processes.