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ISPOR TASK FORCE REPORT
Budget Impact Analysis—Principles of Good Practice: Report of the ISPOR
2012 Budget Impact Analysis Good Practice II Task Force
Sean D. Sullivan, PhD
1
, Josephine A. Mauskopf, PhD
2,
, Federico Augustovski, MD, MSc, PhD
3
, J. Jaime Caro, MDCM, FRCPC,
FACP
4
, Karen M. Lee, MA
5
, Mark Minchin, MBA
6
, Ewa Orlewska, MD, PhD
7,8
, Pete Penna, PharmD
9
,
Jose-Manuel Rodriguez Barrios, RPh, MPH, MSc
10
, Wen-Yi Shau, PhD, MD
11
1
Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, WA, USA;
2
RTI Health Solutions, Research Triangle Park, NC, USA;
3
Health Economic Evaluation and Technology Assessment, Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina;
4
Evidera, Lexington,
MA, USA;
5
Health Economics, Canadian Agency for Drugs and Techno logies in Health, Ottawa, ON, Canada;
6
PASLU, National Institute for Health and Care
Excellence, Manchester, UK;
7
Centre for Pharmacoeconomics, Warsaw, Poland;
8
The Jan Kochanowski University, Kielce, Poland;
9
Formulary Resources, LLC,
Mercer Island, WA, USA;
10
Stryker, Madrid, Spain;
11
Center for Drug Evaluation, Taipei, Taiwan
ABSTRACT
Background: Budget impact analyses (BIAs) are an essential part of a
comprehensive economic assessment of a health care intervention and
are increasingly required by reimbursement authorities as part of a
listing or reimbursement submission. Objectives: The objective of this
report was to present updated guidance on methods for those under-
taking such analyses or for those reviewing the results of such
analyses. This update was needed, in part, because of developments
in BIA methods as well as a growing interest, particularly in emerging
markets, in matters related to affordability and population health
impacts of health care interventions. Methods: The Task Force was
approved by the International Society for Pharmacoeconomics and
Outcomes Research Health Sciences Policy Council and appointed by
its Board of Directors. Members were experienced developers or users
of BIAs; worked in academia and industry and as advisors to govern-
ments; and came from several countries in North America and South
America, Oceania, Asia, and Europe. The Task Force solicited com-
ments on the drafts from a core group of external reviewers and, more
broadly, from the membership of the International Society for Phar-
macoeconomics and Outcomes Research. Results: The Task Force
recommends that the design of a BIA for a new health care intervention
should take into account relevant features of the health care system,
possible access restrictions, the anticipated uptake of the new inter-
vention, and the use and effects of the current and new interventions.
The key elements of a BIA include estimating the size of the eligible
population, the current mix of treatments and the expected mix after
the introduction of the new intervention, the cost of the treatment
mixes, and any changes expected in condition-related costs. Where
possible, the BIA calculations should be performed by using a simple
cost calculator approach because of its ease of use for budget holders.
In instances, however, in which the changes in eligible population size,
disease severity mix, or treatment patterns cannot be credibly captured
by using the cost calculator approach, a cohort or patient-level
condition-specific model may be used to estimate the budget impact
of the new intervention, accounting appropriately for those entering
and leaving the eligible population over time. In either case, the BIA
should use data that reflect values specific to a particular decision
maker’s population. Sensitivity analysis should be of alternative
scenarios chosen from the perspective of the decision maker. The
validation of the model should include at least face validity with
decision makers and verification of the calculations. Data sources for
the BIA should include published clinical trial estimates and compara-
tor studies for the efficacy and safety of the current and new
interventions as well as the decision maker’s own population for the
other parameter estimates, where possible. Other data sources include
the use of published data, well-recognized local or national statistical
information, and, in special circumstances, expert opinion. Reporting
of the BIA should provide detailed information about the input
parameter values and calculations at a level of detail that would allow
another modeler to replicate the analysis. The outcomes of the BIA
should be presented in the format of interest to health care decision
makers. In a computer program, options should be provided for differ-
ent categories of costs to be included or excluded from the analysis.
Conclusions: We recommend a framework for the BIA, provide guid-
ance on the acquisition and use of data, and offer a common reporting
format that will promote s tandardization and transparency. Adherence
to these good research practice principles would not necessarily super-
sede jurisdiction-specific BIA 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, cost calculator, economic
evaluation, methodology, modeling.
Copyright & 2014, International Society for Pharmacoeconomics and
Outcomes Research (ISPOR). Published by Elsevier Inc.
1098-3015/$36.00 – see front matter Copyright & 2014, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.jval.2013.08.2291
E-mail: jmauskopf@rti.org.
* Address correspondence to : Josephine A. Mauskopf, RTI Health Solutions, 3040 Cornwallis Road, Research Triangle Park, NC 27709,
USA.
VALUE IN HEALTH 17 (2014) 5– 14
source: ispor.org
