Using real-world data for coverage and payment decisions: The ISPOR real-world data task force report
Using real-world data for coverage and payment decisions: The ISPOR real-world data task force report
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DOI：
10.1111/j.1524-4733.2007.00186.x
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发表时间：
2007-09-01
期刊：
影响因子：
4.5
通讯作者：
Mullins, Daniel
中科院分区：
文献类型：
--
作者：
Garrison, Louis P., Jr.;Neumann, Peter J.;Mullins, Daniel
目的：参与覆盖和支付政策的卫生决策者越来越多地制定寻求“真实世界”结果信息的政策。出于这些举措，国际社会药物经济学和成果研究（ISPOR）创建了一个工作组对现实世界的数据，制定一个框架，以协助卫生保健决策者在处理RW数据，特别是有关的覆盖面和支付decision.Methods：工作组共同主席由ISPOR董事会选定。共同主席为四个工作组选择了主席：临床结局、经济结局、患者报告结局和证据层次。工作队成员包括学术界、制药业和健康保险公司的代表。工作组举行了多次会议，进行频繁的通信和交流的草案，并征求意见，从一个核心小组的外部审查和ISPOR members.Results：我们定义RW数据用于决策，不收集在传统的随机对照试验（RCT）的数据。我们考虑了几个特征：根据结果类型（临床、经济和患者报告）、证据层次（根据研究设计的强度对证据进行排名）和数据来源类型（随机对照试验、大型简单试验、患者登记、行政索赔数据库、调查和医疗记录的补充数据收集）。我们的报告讨论了八个关键问题：1）RW数据的重要性; 2）RW数据的局限性; 3）所需证据的水平取决于具体情况; 4）收集和报告RW数据需要良好的研究实践; 5）在覆盖和报销决定中使用RW数据需要良好的程序; 6）需要考虑数据收集的成本和效益; 7）建模的持续需求;以及8）利益相关者就这些主题进行持续对话的需求。结论：真实世界的数据对于合理的覆盖范围和报销决策至关重要。这些数据的类型和应用是多种多样的，在任何情况下，上下文在确定特定类型的值时都非常重要。至关重要的是，决策者要认识到使用可再生能源数据的好处、局限性和方法上的挑战，并需要认真考虑在不同情况下收集不同形式数据的成本和好处。
Objectives: Health decision-makers involved with coverage and payment policies are increasingly developing policies that seek information on "real-world" (RW) outcomes. Motivated by these initiatives, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) created a Task Force on Real-World Data to develop a framework to assist health-care decision-makers in dealing with RW data, especially related to coverage and payment decisions.Methods: Task Force cochairs were selected by the ISPOR Board of Directors. Cochairs selected chairs for four working groups on: clinical outcomes, economic outcomes, patient-reported outcomes, and evidence hierarchies. Task Force members included representatives from academia, the pharmaceutical industry, and health insurers. The Task Force met on several occasions, conducted frequent correspondence and exchanges of drafts, and solicited comments on three drafts from a core group of external reviewers and from the ISPOR membership.Results: We defined RW data as data used for decision-making that are not collected in conventional randomized controlled trials (RCTs). We considered several characterizations: by type of outcome (clinical, economic, and patient-reported), by hierarchies of evidence (which rank evidenceaccording to the strength of research design), and by type of data source (supplementary data collection alongside RCTs, large simple trials, patient registries, administrative claims database, surveys, and medical records). Our report discusses eight key issues: 1) the importance of RW data; 2) limitations of RW data; 3) the fact that the level of evidence required depends on the circumstance; 4) the need for good research practices for collecting and reporting RW data; 5) the need for good process in using RW data in coverage and reimbursement decisions; 6) the need to consider costs and benefits of data collection; 7) the ongoing need for modeling; and 8) the need for continued stakeholder dialogue on these topics.Conclusions: Real-world data are essential for sound coverage and reimbursement decisions. The types and applications of such data are varied, and context matters greatly in determining the value of a particular type in any circumstance. It is critical that policymakers recognize the benefits, limitations, and methodological challenges in using RW data, and the need to consider carefully the costs and benefits of different forms of data collection in different situations.