INVESTIGADORES
AUGUSTOVSKI Federico Ariel
artículos
Título:
Budget Impact Analysis-Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force.
Autor/es:
SULLIVAN, S. D.; MAUSKOPF, JA; AUGUSTOVSKI, F. A.; JAIME, C; LEE, KM; MINCHIN, M; ORLEWSKA, M; PENNA, P; RODRIGUEZ BARRIOS, JM; SHAU, WY
Revista:
VALUE IN HEALTH
Editorial:
WILEY-BLACKWELL PUBLISHING, INC
Referencias:
Lugar: Londres; Año: 2014 p. 5 - 14
ISSN:
1098-3015
Resumen:
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 undertaking 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 governments; and came from several
countries in North America and South America, Oceania, Asia, and Europe.
The Task Force solicited comments on the drafts from a core group of
external reviewers and, more broadly, from the membership of the
International Society for Pharmacoeconomics 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 intervention, 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 comparator
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 different categories
of costs to be included or excluded from the analysis.
CONCLUSIONS:
We
recommend a framework for the BIA, provide guidance on the acquisition
and use of data, and offer a common reporting format that will promote
standardization and transparency. Adherence to these good research practice
principles would not necessarily supersede jurisdiction-specific BIA
guidelines but may support and enhance local recommendations or serve as
a starting point for payers wishing to promulgate methodology
guidelines.
© 2013 International Society for Pharmacoeconomics and
Outcomes Research (ISPOR) Published by International Society for
Pharmacoeconomics and Outcomes Research (ISPOR) All rights reserved.