Masucci Lisa, Lewis Diedron, Zhao Jiahao, Carter Caitlin, Chan Kelvin K W, Wong William W L
Toronto Health Economics and Technology Assessment Collaborative, https://ror.org/026pg9j08Toronto General Hospital, Toronto, ON, Canada.
School of Pharmacy, https://ror.org/01aff2v68University of Waterloo, Waterloo, ON, Canada.
Int J Technol Assess Health Care. 2025 Sep 12;41(1):e67. doi: 10.1017/S0266462325100445.
Real-world evidence (RWE) is increasingly used to assess and make regulatory decisions on health technologies. However, its application in healthcare payer decision-making is less well-known.
The objectives of this study were to (i) review the recent literature on how RWE has been used by healthcare payers, (ii) highlight barriers that limit the use of RWE in payer decision making, and (iii) explore how RWE has been used in various funding arrangements between payers and manufacturers. The benefits of utilizing RWE are also discussed.
A scoping review was conducted on articles published between 2014 and 2025 in PubMed (Medline), OVID EMBASE, Cochrane Library, and ProQuest Dissertations and Theses Global. Eligible articles were those written in English that discussed the use of real-world evidence among healthcare payers/decision-makers for health technology reimbursement decisions.
Nineteen articles were selected for full-text review based on the inclusion criteria. The review highlighted payers' interest in incorporating RWE into funding and reimbursement decisions to address uncertainty in the performance of new health technologies. However, a lack of standards for collecting, analyzing, and reporting RWE limits its use. Little is known about how RWE is used in reimbursement decisions since contractual arrangements between payers and manufacturers are confidential.
Although payers are interested in using RWE to inform funding and reimbursement decisions, there are concerns regarding the scientific rigor used to generate such evidence. Having more insight into the contractual arrangements between payers and manufacturers would help to better understand how RWE informs these agreements.
真实世界证据(RWE)越来越多地用于评估卫生技术并做出监管决策。然而,其在医疗保健支付方决策中的应用却鲜为人知。
本研究的目的是:(i)回顾近期关于医疗保健支付方如何使用RWE的文献;(ii)强调限制RWE在支付方决策中使用的障碍;(iii)探讨RWE在支付方与制造商之间的各种资金安排中是如何使用的。还讨论了利用RWE的好处。
对2014年至2025年间发表在PubMed(Medline)、OVID EMBASE、Cochrane图书馆以及ProQuest学位论文与全球博硕士论文数据库中的文章进行了范围综述。符合条件的文章是用英文撰写的,讨论了医疗保健支付方/决策者在卫生技术报销决策中使用真实世界证据的情况。
根据纳入标准,选择了19篇文章进行全文综述。该综述强调了支付方有兴趣将RWE纳入资金和报销决策,以解决新卫生技术性能方面的不确定性。然而,缺乏收集、分析和报告RWE的标准限制了其使用。由于支付方与制造商之间的合同安排是保密的,关于RWE在报销决策中如何使用知之甚少。
尽管支付方有兴趣使用RWE为资金和报销决策提供信息,但对于用于生成此类证据的科学严谨性存在担忧。深入了解支付方与制造商之间的合同安排将有助于更好地理解RWE如何为这些协议提供信息。