OBJECTIVES: Although only 7 pharmacoeconomic and 6 submission guidelines require partial or total budget impact analyses (BIA), affordability is becoming a key issue to decision-makers. Our aim was to review the published BIAs according to different quality assessment criteria. METHODS: PubMed and EMBASE were searched for articles with the search terms “budget impact” or “budget analysis” limited to English language. Relevant articles were abstracted by aim, funding, technology and various issues concerning the analyses. RESULTS: 16 studies were found between 2001 and 2006, the majority prepared for pharmaceuticals, and from the US; however, 50% had BIA only as complementary calculation to economic evaluations. In the US, due the dominance of private health insurance, and in France due to the submission requirements, all studies had BIA as their main aim. Industry funding was stated for 63%; however, industry affiliation was present for a further 13%. In accordance with the aim of assisting NHS systems and insurance companies determine affordability, the payer perspective was chosen in all of the studies, complemented in a few cases by patient or societal perspective. Direct medical costs (63%) or only drug costs (19%) were assessed mostly for one year (44%). Epidemiological data or rate of adoption was mainly based on literature and assumptions. Results were reported by resource type in only 6 (38%) studies, even though this would help to realize a re-deployment of resources. The majority (56%) were either cost-saving or had cost-saving scenarios. A sensitivity analysis was done in only half of the studies for BIAs and in a further 25% for economic evaluation only. CONCLUSIONS: Although affordability is major issue in health care finance, BIAs are still rare and frequently do not seem to generate independent analyses. The quality of many studies also fails to reach desired attributes.