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

Vooren, Katelijne van de; Duranti, Silvy; Curto, Alessandro; Garattini, Livio

doi:10.1007/s40258-013-0064-7

Cited by 49 publications

(58 citation statements)

References 25 publications

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“…A summary of recommended design and common design flaws identified in this review is presented in Table 4. The finding of variability in the inclusion of key design elements was also made in the previous reviews of budget-impact analyses, including the review by Orlewska and Gulácsi [20] and the recent review of budget-impact analyses for European Union countries by van de Vooren et al [21]. Our review has provided additional details about deviations from recommended practice for each of the seven key elements.…”

Section: Discussionsupporting

confidence: 64%

“…All previous reviews of budget-impact models have presented information on model design and have concluded that it is variable [19][20][21]. As found in this review, this variability persists.…”

Section: Discussionmentioning

confidence: 51%

“…The van de Vooren et al [21] review also expressed a concern that most of the published budget-impact models for European Union countries were sponsored by the drug manufacturer and that this might introduce bias into the estimates. They specifically state that this bias could be introduced either by the model design or the input parameter values.…”

Section: Discussionmentioning

confidence: 99%

“…Although issues around recommended practice in model design have been found in our review as in the previous reviews, we believe these issues may be due to the relative newness of these types of analyses in the published literature and associated lack of guidance for researchers and peer-reviewers rather than the sponsor of the study. To determine whether the results of a specific analysis are biased would require a detailed evaluation of both the model design and the input parameter sources and assumptions, which was beyond the scope of this review and was not attempted in the van de Vooren et al [21] review.…”

Section: Discussionmentioning

confidence: 99%

“…The authors concluded that there was fairly good agreement with published guidelines for most elements, with the exceptions of reporting, uncertainty analysis, and discounting. Most recently, van de Vooren et al [21] reviewed 17 published budget-impact analyses for drug introductions in European Union countries. They concluded from this review that budget-impact analysis is not a well-established technique and many studies are not of acceptable quality.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

A Methodological Review of US Budget-Impact Models for New Drugs

Mauskopf

Earnshaw

2016

PharmacoEconomics

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A budget-impact analysis is required by many jurisdictions when adding a new drug to the formulary. However, previous reviews have indicated that adherence to methodological guidelines is variable. In this methodological review, we assess the extent to which US budgetimpact analyses for new drugs use recommended practices. We describe recommended practice for seven key elements in the design of a budget-impact analysis. Targeted literature searches for US studies reporting estimates of the budget impact of a new drug were performed and we prepared a summary of how each study addressed the seven key elements. The primary finding from this review is that recommended practice is not followed in many budgetimpact analyses. For example, we found that growth in the treated population size and/or changes in disease-related costs expected during the model time horizon for more effective treatments was not included in several analyses for chronic conditions. In addition, all drug-related costs were not captured in the majority of the models. Finally, for most studies, one-way sensitivity and scenario analyses were very limited, and the ranges used in one-way sensitivity analyses were frequently arbitrary percentages rather than being data driven. The conclusions from our review are that changes in population size, disease severity mix, and/or disease-related costs should be properly accounted for to avoid over-or underestimating the budget impact. Since each budget holder might have different perspectives and different values for many of the input parameters, it is also critical for published budget-impact analyses to include extensive sensitivity and scenario analyses based on realistic input values. Key Points for Decision MakersPublished budget-impact analyses do not always estimate changes in the treated population size and related changes in the disease-related costs of drugs for chronic conditions that reduce mortality rates or slow disease progression, which may result in overor underestimates of the budget impact of a new drug.Treatment switching or discontinuation may not be appropriately included in many published budgetimpact analyses.Sensitivity and scenario analyses presented in published budget-impact analyses are typically too limited to allow a budget holder to assess the likely budget impact for their health plan.

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 51%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

A Methodological Review of US Budget-Impact Models for New Drugs

Mauskopf

Earnshaw

2016

PharmacoEconomics

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Creating Your Own Budget-Impact Analyses Today and Tomorrow

Mauskopf

Earnshaw

Brogan

2017

Budget-Impact Analysis of Health Care Interventions

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Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries

et al. 2014

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The first biosimilar monoclonal antibody (infliximab, CT-P13) was registered by the European Medicines Agency in 2013 for the treatment of several inflammatory conditions including rheumatoid arthritis (RA). Biosimilar infliximab is first being marketed in the Central and Eastern European countries. This paper presents the estimated budget impact of the introduction of biosimilar infliximab in RA over a 3-year time period in six selected countries, namely Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. A prevalence-based model was constructed for budget impact analysis. Two scenarios were compared to the reference scenario (RSc) where no biosimilar infliximab is available: biosimilar scenario 1 (BSc1), where interchanging the originator infliximab with biosimilar infliximab is disallowed, and only patients who start new biological therapy are allowed to use biosimilar infliximab; as well as biosimilar scenario 2 (BSc2), where interchanging the originator infliximab with biosimilar infliximab is allowed, and 80 % of patients treated with originator infliximab are interchanged to biosimilar infliximab. Compared to the RSc, the net savings are estimated to be €15.3 or €20.8 M in BSc1 and BSc2, respectively, over the 3 years. If budget savings were spent on reimbursement of additional biosimilar infliximab treatment, approximately 1,200 or 1,800 more patients could be treated in the six countries within 3 years in the two biosimilar scenarios, respectively. The actual saving is most sensitive to the assumption of the acquisition cost of the biosimilar drug and to the initial number of patients treated with biological therapy. The study focused on one indication (RA) and demonstrated that the introduction of biosimilar infliximab can lead to substantial budget savings in health care budgets. Further savings are expected for other indications where biosimilar medicines are implemented.

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

Cited by 49 publications

References 25 publications

A Methodological Review of US Budget-Impact Models for New Drugs

A Methodological Review of US Budget-Impact Models for New Drugs

Creating Your Own Budget-Impact Analyses Today and Tomorrow

Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries

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