Principles of Good Practice for Budget Impact Analysis:
Report of the ISPOR Task Force on Good Research Practices—
Budget Impact Analysis
Josephine A. Mauskopf, PhD,1 Sean D. Sullivan, PhD,2 Lieven Annemans, PhD, MSc,3 Jaime Caro, MD,4
C. Daniel Mullins, PhD,5 Mark Nuijten, PhD, MBA, MD,6 Ewa Orlewska, MD, PhD,7 John Watkins, RPh, MPH,8
Paul Trueman, MA, BA9
1
RTI Health Solutions, Research Triangle Park, NC, USA; 2University of Washington, Seattle, WA, USA; 3IMS Health, Brussels, Belgium;
Caro Research, Concord, MA, USA; 5University of Maryland, Baltimore, MD, USA; 6Imta, Erasmus University, Rotterdam, The Netherlands;
7
Centre for Pharmacoeconomics, Warsaw, Poland; 8Premera Blue Cross, Bothell, WA, USA; 9York Health Economics Consortium,York, UK
4
A B S T R AC T
Objectives: 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 Bene?ts Advisory Committee in Australia, as well as
managed care organizations in the United States, now require
that companies submit estimates of both the costeffectiveness 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.
Methods: The Task Force was appointed with the advice and
consent of the Board of Directors of ISPOR. Members were
experienced developers or users of budget impact models,
worked in academia, industry, and as advisors to governments, and came from several countries in North America,
Oceana, Asia, and Europe. The Task Force met to develop
core assumptions and an outline before preparing a draft
report. They solicited comments on the outline and two
drafts from a core group of external reviewers and more
broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site.