Published Oct 2007
Citation
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 Health. 2007;10(5):336-347.
Abstract
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
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.
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.
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. The
primary data sources for estimating the budget impact should
be published clinical trial estimates and comparator studies
for efficacy and safety of current and new technologies as
well as, where possible, the decision-maker’s own population
for the other parameter estimates.
Suggested default data
sources also are recommended. These include the use of
published data, well-recognized local or national statistical
information and in special circumstances, expert opinion.
Finally, the Task Force recommends that the analyst use the
simplest design that will generate credible and transparent
estimates. If a health condition model is needed for the BIA,
it should reflect health outcomes and their related costs in the
total affected population for each year after the new intervention
is introduced into clinical practice. The model should
be consistent with that used for the CEA with regard to
clinical and economic assumptions.
Conclusions: 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.
Keywords: budget impact analysis, economic evaluation,
methodology, modeling
Copyright © 2007, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
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