School of Epidemiology and Public Health,University of Ottawa,Ottawa,Canada.
Ontario SPOR Support Unit,Toronto,Canada.
Int J Technol Assess Health Care. 2019 Jan;35(3):181-188. doi: 10.1017/S0266462319000291. Epub 2019 May 28.
Canada has a long history of the use of clinical evidence to support healthcare decision making. Given improvements in data holdings and analytic capacity in Canada and stakeholder interest, the purpose of this study is to reflect on perceptions of the value of real-world evidence in pricing and reimbursement decisions, barriers to its optimal use in pricing and reimbursement, current initiatives that may lead to its increased use, and what role the pharmaceutical industry may play in this.Methods/ResultsTo capture stakeholder perceptions, ninety-one participants identified as key stakeholders were identified according to background roles and geography and invited to participate in four round table discussions conducted under Chatham House rule. Important themes emerging from these discussions included: (i) the need to understand what "real world" evidence means; (ii) barriers to using real world evidence from differences in access, governance, inter-operability, system structures, expertise, and quality across Canadian health systems; (iii) differing views on industry's role.
The use of real-world data in Canada to inform pricing and reimbursement decisions is far from routine but nascent and slowly increasing. Barriers, including interoperability concerns, may also apply to other federated health systems that need to focus on the networking of healthcare administrative data across provincial jurisdictional boundaries. There also appears to be a desire to see better use of pragmatic trials linked to these administrative data sets. Emerging initiatives are under way to use real world evidence more broadly, and include identification of common data elements and approaches to networking data.
加拿大在利用临床证据支持医疗保健决策方面有着悠久的历史。鉴于加拿大在数据持有量和分析能力方面的改进以及利益相关者的兴趣，本研究旨在反映对真实世界证据在定价和报销决策中的价值的看法，在定价和报销中充分利用它的障碍，可能导致其使用增加的当前举措，以及制药行业可能在这方面发挥的作用。
方法/结果：为了捕捉利益相关者的看法，根据背景角色和地理位置确定了 91 名被认为是关键利益相关者的参与者，并邀请他们参加根据查塔姆宫规则进行的四轮圆桌讨论。这些讨论中出现的重要主题包括：（i）需要了解“真实世界”证据的含义；（ii）由于加拿大卫生系统之间在获取、治理、互操作性、系统结构、专业知识和质量方面的差异，使用真实世界证据的障碍；（iii）对行业角色的不同看法。
在加拿大，使用真实世界数据来为定价和报销决策提供信息的做法远非常规，但正在萌芽并缓慢增加。障碍包括互操作性问题，这也可能适用于其他需要关注省级管辖边界内医疗保健管理数据联网的联邦卫生系统。似乎也有人希望看到更好地利用与这些管理数据集相关的实用试验。正在开展新的举措，以更广泛地使用真实世界证据，包括确定共同数据元素和数据联网方法。
