Published Sep 2007
Garrison LP Jr, Neumann PJ, Erickson P, et al. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force Report. Value Health. 2007;10(5):326-335.
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, patientreported 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 decisionmaking that are not collected in conventional randomized controlled trials (RCTs). We considered several characterizations: by type of outcome (clinical, economic, and patientreported), by hierarchies of evidence (which rank evidence according 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.
Keywords: methodology, outcomes research, real-world data, research design.