OBJECTIVES: The French national authority of health (HAS) published a methodological guide on budget impact analysis (BIM) in 2016; and then, a guide on organizational impacts (OI) in 2020-2021. Since 2020, a new type of modelling is appearing by the combination of OI and BIM that we called budget and organizational impact models (OBIM). More recently, French law has created a specific procedure for the listing of innovative and complex health products in hospitals based on the Value-Based Procurement. Given this context, the aim of this study was to provide an overview of impact studies conducted in Europe.

METHODS: A literature review was conducted on PubMed. Based on a title, abstract and full text selection, 54 articles were selected. These articles have presented a budget impact model (BIM) or an economic analysis (EA) or an organizational impact (OI) or a budget and organizational impact model (OBIM). Descriptive analyses were performed to present the types of impact models developed for drugs or medical devices between 2014 and 2024, in Europe.

RESULTS: Of the 54 selected articles, 83% presented results from a BIM and EA, 13% from an OBIM, and 4% from an OI. Of the 54 analyses, 87% focused on drugs and only 13% on medical devices. Overall, these models were developed to analyze the impact of drugs or medical devices in oncology and hematology (19%), rheumatology and immunology (18%), gastroenterology (12%), and infectious diseases (12%). Among OBIMs, 40% had been conducted on a medical device. OBIMs incorporated organizational outcome criteria such as length of hospital stay, number of emergency department visits and environmental impact (CO2 emissions).

CONCLUSIONS: Although demonstrating the value of health products is increasingly required by institutions as part of market access, OBIM and OI remain significantly underdeveloped as of 2024.