艾昆纬：2026肿瘤学HTA决策中真实世界证据的角色演进：机遇与挑战白皮书（英文版）（28页）.pdf

1、White PaperThe Evolving Role of Real-World Evidence in Oncology HTA Decision-Making:Opportunities and Challenges TOM NIJHUIS,Principal,Value and Payer Evidence,IQVIA MAX SCHLUETER,Senior Principal,Health Economics/HTA offering,Value and Payer Evidence,IQVIA ANA LISICA,Manager,Strategy Consulting,IQV

2、IATable of contentsIntroduction 1Guidelines for the use of RWE in regulatory decisions 1RWE in HTA decision-making 3RWE and joint clinical assessment 6RWE and international collaborations 6Current challenges around the use of RWE in HTA 7Application of RWE in Oncology 7RWE contribution to HTA outcom

3、es 9Receptiveness to RWE across HTA bodies 11Case studies:Use of RWE as an External Control Arm Libtayo and Ayvakit 12Case study:Use of RWE in Carvykti,Tecvayli and Talvey HTA submissions 15Discussion 18Conclusion 20About the authors 21References 22 |1The use of Real-World Evidence(RWE)as a componen

4、t of Health Technology Assessment(HTA)submissions has seen a marked increase in the last 5 years,reflecting the growing recognition of RWEs potential to enhance the understanding of health interventions in real-world settings,thereby informing more comprehensive and nuanced decision-making.1,2 While

5、 Randomised Controlled Trials(RCTs)remain the gold standard for evidence generation,they can be challenging to conduct in niche oncology populations or in rare tumours and hampered by long timelines required to generate mature overall survival data or variability in Standards of Care(SoC)across mark

6、ets.These limitations underscore the growing importance of RWE in supporting regulatory and HTA decision-making in oncology.This report builds on IQVIAs Institute for Data Science 2022 report on Impact of RWE on HTA decision-making.2 It examines the practical application of RWE in oncology,a therapy