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Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices – Budget Impact Analysis
The citation for this report is: Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices – Budget Impact Analysis.
Value in Health 2007;10;336-47
Task Force Chairs:
Jo Mauskopf PhD, RTI Health Solutions, RTI
International, Research Triangle Park, North Carolina, USA
Sean Sullivan PhD, RPh, MS, Professor and Director,
University of Washington, Pharmaceutical Outcomes Research and Policy
Program, Seattle, WA, USA
Leadership Group:
Lieven Annemans PhD, MSc, , Health Economist, Ghent
University and Senior Consultant Global Health Economic, HEDM and
IMS Health, Brussels, Belgium
Jaime Caro, MD, Scientific Director, Caro Research,
Concord, MA, USA
C. Daniel Mullins PhD, Professor and Chair of
Pharmaceutical Health Services Research, University of Maryland,
School of Pharmacy, Baltimore, MD, USA
Mark Nuijten PhD, MBA, MD, Researcher, Imta, Erasmus
University, Rotterdam, The Netherlands
Ewa Orlewska MD, PhD, Lecturer, Centre for
Pharmacoeconomics, Warsaw, Poland
Paul Trueman MA, BA, Director, York Health Economics
Consortium, Heslington, York, UK
John Watkins RPh MPH, Pharmacy Manager, Formulary
Development, Premera Blue Cross, Bothell, WA, USA
ABSTRACT
OBJECTIVES:
There is growing recognition that a comprehensive economic assessment of
a new health care intervention at the time of launch requires both
cost-effectiveness analysis (CEA) and a budget impact analysis (BIA).
National regulatory agencies such as the National Institute for Health
and Clinical Excellence (NICE) in England and Wales and the
Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, as well
as managed care organizations (MCOs) in the USA, 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.
While 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 web site.
RESULTS: The Task Force recommends that the budget impact of a new health
technology should consider the perspective of the specific health care decision
maker. As such, the BIA should be performed using data that reflect, for a
specific health condition, the size and characteristics of the population, the
current and new treatment mix, the efficacy and safety of the new and current
treatments, and the resource use and costs for the treatments and symptoms as
would apply to the population of interest.
The Task Force recommends that budget impact analyses be generated as a series
of scenario analyses in the same manner that sensitivity analyses would be
provided for CEAs. In particular, the input values for the calculation and the
specific cost outcomes presented (a scenario) should be specific to a particular
decision maker’s population and information needs. Sensitivity analysis should
also be in the form of alternative scenarios chosen from the perspective of the
decision maker.
CONCLUDING STATEMENT: Budget impact analysis is important, along with
cost-effectiveness analysis, 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.
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