There is a growing interest to utilize real-world evidence (RWE) by various stakeholders across the entire healthcare value chain, including using RWE to guide health technology assessment (HTA). The extent to which it was used in evaluations of pharmaceutical products during HTA processes is not clear.

The objectives of this session are 1) to provide an overview of current use of RWE in HTA processes in US, Europe and Japan, 2) to share results from analysis to evaluating the use of RWE in HTA processes globally using HTA accelerator®, 3) to highlight opportunities to increase use of RWE in HTA processes.

The first speaker will provide an overview of current use of RWE in HTA processes, including ICER’s clinical evidence assessment, and use of RWE in payer decision making. The speaker will also highlight key challenges.

The second speaker will present results from analysis for use of RWE in HTA processes using HTA accelerator®, a database containing submission information for payer assessments. Amongst the 10 largest pharmaceutical markets, the United Kingdom, France, United States, Germany continue to dominate RWE use in HTA. 37% of submissions (n=180/486) included RWE as supporting evidence. Furthermore, RWE use accelerated during this period over tenfold with 45% (n=81/180) documented in Jan-May, 2022 in contrast to 3% (n=5/180) in 2017. Additional results will be presented, including how and what the RWE was submitted in support of comparative safety and/or effectiveness assessment.

The third speaker will highlight opportunities to increase use of RWE in HTA processes, particularly updates from ISPOR RWE Transparency Initiative. For RW studies that are meant to test hypotheses about comparative effectiveness or safety, a key aspect of credibility is that they are conducted transparently with tests that follow a prespecified protocol.

The session will be concluded by a discussion between audience and speakers.