Use of Real-World Evidence in Health Technology Assessment Submissions

Yingyi Liu and Julia Ma ()
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Yingyi Liu: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Julia Ma: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie

A chapter in Real-World Evidence in Medical Product Development, 2023, pp 321-338 from Springer

Abstract: Abstract Although randomized clinical trials (RCTs) have been perceived as the gold standard to demonstrate efficacy and safety, real-world evidence (RWE) gathered outside of RCTs now plays an increasingly important role in health technology assessment (HTA) submissions. RWE from sources such as prospective and retrospective real-world studies have been submitted to HTA bodies to identify treatment patterns, to characterize patients, and to provide supportive evidence for the economic evaluations. This chapter will focus on the utility and strengths of well-developed RWE in HTA submissions and decision-making. While most HTA bodies have become more open to RWE in recent years, the practice varies among the agencies and guidance development is at different stages. We will also discuss the recent trend of incorporating RWE in HTA submissions, focusing on several leading HTA bodies.

Keywords: Health technology assessment; Real-world evidence; Cost-effectiveness (search for similar items in EconPapers)
Date: 2023
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-031-26328-6_17

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DOI: 10.1007/978-3-031-26328-6_17

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