Proposal of polish guidelines for conducting financial analysis and their comparison to existing guidance on budget impact in other countries

Background: Financial analysis (budget impact analysis, BIA) is increasingly required by decision-makers to ascertain the macroeconomic consequences of new product reimbursement in addition to proof of cost-effectiveness. Poland is in the process of drafting country-specific guidelines for BIA, positioned as complementary to economic evaluation in decision-making Objectives: The aim of this article is to present the Polish project and compare it with currently available guidance. Methods: A checklist was developed that focuses on issues that are unique to BIA. An analysis of the differences between different national guidelines and their Polish counterparts was subsequently undertaken. Results: The Polish project of BIA guidelines is composed of two sections. The first section presents the objective, the use of BIA, the responsibility for the preparation, and the target audience. The second section presents important methodological aspects that researchers should keep in mind when carrying out BIA. In comparison to existing guidance the Polish project appears to be more detailed. It includes more precise recommendations on perspective, time horizon, and reliability of data sources; reporting of results; rates of adoption of new therapies; and the probability of redeploying resources. Conclusions: Although there is an increased demand for BIA, there is only limited guidance on how such studies should be undertaken. It is hoped that the Polish guidelines can contribute to the development of such analyses and deliver benefit for Polish health-care decision-makers and beyond.