OBJECTIVES: A budget impact analysis (BIA) model serves as a health economic modeling tool to estimate the prospective financial consequences associated with the introduction of a novel pharmaceutical drug into the market. This research aims to assess the quality of globally-published BIAs when compared with the guidelines outlined in the ISPOR Budget Impact Analyses: Principles of Good Practice Report.

METHODS: A targeted literature search from 2018-2022 was conducted using SCOPUS, Health Business Elite, EconLit, Pubmed, and Cochrane databases. BIAs conducted for non-US countries were included. Publication characteristics such as perspective, treatment and disease-related costs, validation, and uncertainty analyses were extracted and recorded.

RESULTS: A total of 76 BIA articles were identified and evaluated based on the inclusion and exclusion parameters. Only 23 studies (30.3%) mentioned following the ISPOR guidelines. The majority (n= 70) of BIA’s considered a national payer/health system/societal perspective, and few, (n= 2) and (n= 6) considered a hospital and private payer perspective respectively. All studies included treatment-related costs and over 70% (n=55) of the studies included disease-related costs in their models. Most studies (n=66) conducted uncertainty analyses including one-way sensitivity, deterministic, scenario, probabilistic and univariate analyses. Although discounting is not recommended by the ISPOR guidelines, a few studies (n= 13) included discounting in their estimates. Model validation using face validity, verification of calculations and/or validation of input variables were seen in over half of the studies (n=45).

CONCLUSIONS: This review highlights that many studies vary in their adherence to recommended guidelines. The model validation process was lacking in many studies, and discounting was commonly used despite it not being recommended. Disease-related costs should be considered in order to avoid under- or over- estimating the budget impact of new treatments. It is important for BIAs to adhere to ISPOR guidelines to be useful in making health care decisions.