Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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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. ⋯ 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.
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There is growing recognition that a comprehensive economic assessment of a new health-care intervention at the time of launch requires both a cost-effectiveness analysis (CEA) and a budget impact analysis (BIA). National regulatory agencies such as the National Institute for Health and Clinical Excellence in England and Wales and the Pharmaceutical Benefits Advisory Committee in Australia, as well as managed care organizations in the United States, now require that companies submit estimates of both the cost-effectiveness and the likely impact of the new health-care interventions on national, regional, or local health plan budgets. Although standard methods for performing and presenting the results of CEAs are well accepted, the same progress has not been made for BIAs. The objective of this report is to present guidance on methodologies for those undertaking such analyses or for those reviewing the results of such analyses. ⋯ The BIA is important, along with the CEA, as part of a comprehensive economic evaluation of a new health technology. We propose a framework for creating budget impact models, guidance about the acquisition and use of data to make budget projections and a common reporting format that will promote standardization and transparency. Adherence to these proposed good research practice principles would not necessarily supersede jurisdiction-specific budget impact guidelines, but may support and enhance local recommendations or serve as a starting point for payers wishing to promulgate methodology guidelines.