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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References
Trueman P, Drummond M, Hutton J. Developing guidance for budget impact analysis. Pharmacoeconomics. 2001;19(6):609–21.
Mauskopf JA, Sullivan S, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR task force on good research practices-budget impact analysis. Value Health. 2007;10(5):336–47.
Marshall DA, Douglas PR, Drummond M, et al. Guidelines for conducting pharmaceutical budget impact analyses for submission to public drug plans in Canada. Pharmacoeconomics. 2008;26(6):477–95.
Orlewska E, Gulácsi L. Budget-impact analyses: a critical review of published studies. Pharmacoeconomics. 2009;27(10):807–27.
Garattini L, Van de Vooren K. Budget impact analysis in economic evaluation: a proposal for a clearer definition. Eur J Health Econ. 2011;12(6):499–502.
De Pouvourville G, Ulmann P, Nixon J, et al. The diffusion of health economics knowledge in Europe: the EURONHEED (European Network of Health Economic Evaluation Databases) Project. Pharmacoeconomics. 2005;23(2):113–20.
Mauskopf J. Prevalence-based economic evaluation. Value Health. 1998;1(4):251–9.
Atkins KE, Shim E, Carroll S, et al. The cost-effectiveness of pentavalent rotavirus vaccination in England and Wales. Vaccine. 2012;30(48):6766–76.
Geitona M, Carayanni V, Petratos P. Economic evaluation of opioid substitution treatment in Greece. Heroin Addict Relat Clin Probl. 2012;14(3):77–88.
Fragoulakis V, Kourlaba G, Goumenos D, et al. Economic evaluation of intravenous iron treatments in the management of anemia patients in Greece. Clin Econ Outcomes Res. 2012;4:127–34.
Bager P, Dahlerup JF. The health care cost of intravenous iron treatment in IBD patients depends on the economic evaluation perspective. J Crohns Colitis. 2010;4(4):427–30.
Purmonen TT, Auvinen PK, Martikainen JA. Budget impact analysis of trastuzumab in early breast cancer: a hospital district perspective. Int J Technol Assess Health Care. 2010;26(2):163–9.
Cicchetti A, Ruggeri M, Gitto L, et al. Extending influenza vaccination to individuals aged 50–64: a budget impact analysis. Int J Technol Assess Health Care. 2010;26(3):288–93.
De Salas-Cansado M, Cuadros M, Del Cerro M, et al. Budget impact analysis in Spanish patients with Dupuytren’s contracture: fasciectomy vs. collagenase Clostridium histolyticum. Chir Main. 2013. pii: S1297-3203(13)00032-2.
Simoens S, Laekeman G, Decramer M. Preventing COPD exacerbations with macrolides: a review and budget impact analysis. Respir Med. 2013. pii: S0954-6111(12)00506-9.
Gordon J, Evans M, McEwan P, et al. Evaluation of insulin use and value for money in type 2 diabetes in the United Kingdom. Diabetes Ther. 2013 (Epub ahead of print).
Jiang Y, Gauthier A, Annemans L, et al. A public health and budget impact analysis of vaccinating at-risk adults and the elderly against pneumococcal diseases in Germany. Expert Rev Pharmacoecon Outcomes Res. 2012;12(5):631–43.
Avgerinou G, Bassukas I, Chaidemenos G, et al. Budget impact analysis of ustekinumab in the management of moderate to severe psoriasis in Greece. BMC Dermatol. 2012;12:10.
Dee A, Hutchinson M, De La Harpe D. A budget impact analysis of natalizumab use in Ireland. Ir J Med Sci. 2012;181(2):199–204.
Thorlund K, Druyts E, El Khoury AC, Mills EJ. Budget impact analysis of boceprevir and telaprevir for the treatment of hepatitis C genotype 1 infection. Clinicoecon Outcomes Res. 2012;4:349–59.
Rønborg SM, Svendsen UG, Micheelsen JS, et al. Budget impact analysis of two immunotherapy products for treatment of grass pollen-induced allergic rhinoconjunctivitis. Clinicoecon Outcomes Res. 2012;4:253–60.
Fragoulakis V, Kourlaba G, Maniadakis N. Economic evaluation of statins in high-risk patients treated for primary and secondary prevention of cardiovascular disease in Greece. Clinicoecon Outcomes Res. 2012;4:135–43.
Gazzard B, Hill A, Anceau A. Cost-efficacy analysis of the MONET trial using UK antiretroviral drug prices. Appl Health Econ Health Policy. 2011;9(4):217–23.
Guest JF, Concolino D, Di Vito R, et al. Modelling the resource implications of managing adults with Fabry disease in Italy. Eur J Clin Invest. 2011;41(7):710–8.
Guest JF, Jenssen T, Houge G, et al. Modelling the resource implications of managing adults with Fabry disease in Norway favours home infusion. Eur J Clin Invest. 2010;40(12):1104–12.
Purmonen T, Nuttunen P, Vuorinen R, et al. Current and predicted cost of metastatic renal cell carcinoma in Finland. Acta Oncol. 2010;49(6):837–43.
Gani R, Griffin J, Kelly S, Rutten-van Mölken M. Economic analyses comparing tiotropium with ipratropium or salmeterol in UK patients with COPD. Prim Care Respir J. 2010;19(1):68–74.
Colin X, Lafuma A, Costagliola D, et al. Modelling the budget impact of darunavir in the treatment of highly treatment-experienced, HIV-infected adults in France. Pharmacoeconomics. 2010;28(Suppl 1):183–97.
Taylor DCA, Chu P, Rosen VM, et al. Budgetary impact of varenicline in smoking cessation in the United Kingdom. Value Health. 2009;12(1):28–33.
Launois R, Payet S, Saidenberg-Kermanac’h N, et al. Budget impact model of rituximab after failure of one or more TNFalpha inhibitor therapies in the treatment of rheumatoid arthritis. Joint Bone Spine. 2008;75(6):688–95.
NICE. Methods guide. Assessing cost impact. http://www.nice.org.uk/media/99A/F8/Costing_Manual_update_050811.pdf (Accessed 20 Aug 2013).
Garattini L, Koleva D, Casadei G. Modeling in pharmacoeconomic studies: funding sources and outcomes. Int J Technol Assess Health Care. 2010;26(3):330–3.
Drugs and devices look more effective in studies sponsored by industry. BMJ. 2012;345:e8386.
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.
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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