title: A critical systematic review of budget impact analyses on drugs in the EU countries.
abstract: BACKGROUND
  Budget impact analysis (BIA) is a relatively recent technique that is supposed to be complementary to more established economic evaluations (EEs).
  
  
  OBJECTIVE
  We reviewed the BIAs published on drugs in the EU since December 2008, to assess whether these studies have improved in quality in the last few years.
  
  
  METHODS
  We conducted a literature search on the international databases PubMed and EMBASE. The selected articles were screened using a two-step approach to assess (1) their main methodological characteristics and (2) the level of adherence to the latest BIA definition. The assessment was made by two independent reviewers and any disagreement was resolved through discussion.
  
  
  RESULTS
  Eventually, 17 articles were reviewed. Thirteen referred to a stand-alone BIA not accompanying a full EE, only nine focussed on a new treatment, 15 were sponsored by the manufacturer of the drug of reference, all but one claiming savings for healthcare budgets. The quality of methods was poor in many of the studies, and only a few of them attempted to estimate real local costs in a credible way. Therefore, the crucial items that in theory make a BIA different from other types of EEs were often the major points of weakness of the studies reviewed.
  
  
  CONCLUSIONS
  Our review confirmed that the BIA is not yet a well-established technique in the literature and many published studies still fail to reach an acceptable quality. In particular, BIAs funded by pharmaceutical companies appear to be tailored to show short-term savings induced by new, highly priced products.
authors.affiliation: CESAV, Center for Health Economics, IRCCS Institute for Pharmacological Research 'Mario Negri', Via Camozzi 3, 24020, Ranica, Italy.
authors.forename: Katelijne
authors.initials: K
authors.lastname: van de Vooren
authors.forename: Silvy
authors.initials: S
authors.lastname: Duranti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Curto
authors.forename: Livio
authors.initials: L
authors.lastname: Garattini
mesh_terms: D035843:Biomedical Research / Q000191:economics*; D002017:Budgets / Q000379:methods; D003365:Costs and Cost Analysis / Q000379:methods; D016527:Drug Costs; D004345:Drug Industry / Q000191:economics*; D005062:European Union / Q000191:economics*; D006801:Humans; D012109:Research Support as Topic / Q000191:economics* / Q000592:standards