OBJECTIVES: A budget impact analyses (BIA) is an economic tool used to predict economic changes of introducing new drugs or indications to the market, it is conducted by reimbursement authorities and health systems to assist in the determination of formulary status. This research aimed to assess the quality of US published budget impact analyses based on the ISPOR Budget Impact Analyses: Principles of Good Practice Report.

METHODS: A targeted literature search from 2015 through 2022 was conducted using SCOPUS, Health Business Elite, EconLit, Pubmed, and Cochrane databases. US budget impact analyses of new FDA approved drugs and drugs with new indications approved in 2015 or later were included. Publication characteristics such as perspective, target population, validation, and uncertainty analyses were extracted and recorded.

RESULTS: A total of 62 articles were identified and evaluated based on the inclusion and exclusion parameters. Overall, the majority (n=59) of BIA’s considered a commercial or a public health plan as the primary perspective, with few (n=3) considering a hospital/health system perspective. The time horizons of all BIAs were specified and ranged from 1 to 5 years. Model validation using face validity or verification of calculations within studies was only seen in a few studies. Although not recommended by the ISPOR guidelines, a six studies conducted discounting. A rebate analysis was conducted in one study, to explore different discounts that could be used to break-even with comparators.

CONCLUSIONS: In this review, the majority of articles included several key elements from the ISPOR BIA guidelines. However, the published budget impact analyses frequently failed to provide a clear description of their model validation process, and the extent of sensitivity analyses varied widely among products and indications.