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A Critical Systematic Review of Budget Impact Analyses on Drugs in the EU Countries

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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.

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Conflict of interest

All authors declare no conflicts of interest.

Author contributions

All authors contributed to the conception and design of this work, commented on drafts and approved the final manuscript. Silvy Duranti and Sandro Curto acted as independent reviewers of the literature and abstracted the studies, Kate van de Vooren wrote the manuscript and Livio Garattini supervised all of the study and acts as guarantor for the content of the paper.

Study funding

No funding was received for the study.

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Correspondence to Livio Garattini.

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van de Vooren, K., Duranti, S., Curto, A. et al. A Critical Systematic Review of Budget Impact Analyses on Drugs in the EU Countries. Appl Health Econ Health Policy 12, 33–40 (2014). https://doi.org/10.1007/s40258-013-0064-7

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  • DOI: https://doi.org/10.1007/s40258-013-0064-7

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