Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices—Budget Impact Analysis

AbstractObjectiveThere 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.MethodsThe 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.ResultsThe 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 resourceuse 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.ConclusionThe 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 localrecommendations or serve as a starting point for payers wishing to promulgate methodology guidelines

The French National Authority for Health (HAS) Guidelines for Conducting Budget Impact Analyses (BIA)

International audienceBackgroundBudget impact analysis (BIA) provides short- and medium-term estimates on changes in budgets and health outcomes resulting from the adoption of new health interventions.ObjectiveThe purpose of this study is to present the newly developed French National Authority for Health (HAS) guidelines on budget impact analysis as follows: process, literature review, recommendations and comparisons with other guidelines.MethodsThe development process of the HAS guidelines included a literature review (search dates: January 2000 to June 2016), a retrospective investigation of BIA previously submitted to HAS, a public consultation, international expert reviews and approval from the HAS Board and the Economic and Public Health Evaluation Committee of HAS.ResultsDocuments identified in the literature review included 12 national guidelines, 5 recommendations for good practices developed by national and international society of health economics and 14 methodological publications including recommendations for conducting BIA. Based on its research findings, HAS developed its first BIA guidelines, which include recommendations on the following topics: BIA definition, perspective, populations, time horizon, compared scenarios, budget impact models, costing, discounting, choice of clinical data, reporting of results and uncertainty exploration.ConclusionIt is expected that the HAS BIA guidelines will enhance the usefulness, quality and transparency of BIA submitted by drug manufacturers to HAS. BIA is becoming an essential part of a comprehensive economic assessment of healthcare interventions in France, which also includes cost-effectiveness analysis and equity of access to healthcare