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Use of Real-World Evidence in Health Technology Assessment Submissions

In: Real-World Evidence in Medical Product Development

Author

Listed:
  • 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)

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.

Suggested Citation

  • Yingyi Liu & Julia Ma, 2023. "Use of Real-World Evidence in Health Technology Assessment Submissions," Springer Books, in: Weili He & Yixin Fang & Hongwei Wang (ed.), Real-World Evidence in Medical Product Development, pages 321-338, Springer.
    • Handle: RePEc:spr:sprchp:978-3-031-26328-6_17
    DOI: 10.1007/978-3-031-26328-6_17
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