The use of budget impact analysis in the economic evaluation of new medicines in Australia, England, France and the United States: relationship to cost-effectiveness analysis and methodological challenges

Ghabri, Salah; Mauskopf, Josephine

doi:10.1007/s10198-017-0933-3

Cited by 23 publications

(15 citation statements)

References 8 publications

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“…After 2010, any recommendation by PBAC that has a financial impact on the Federal government’s budget is reviewed by the cabinet. 2 There is a close relationship between the estimated financial impact of a drug on the Australian drug budget and the rate of PBAC positive recommendations for reimbursement. 3 Belgium has a Bismarck-type social insurance system (multipayer) in which the insurers, called Sickness Funds, are financed by both employers and employees.…”

Section: Supplementary Materialsmentioning

confidence: 99%

A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new drug submissions

Foroutan¹,

Tarride²,

Xie³

et al. 2018

CEOR

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IntroductionBudget impact analysis (BIA) in health care, sometimes referred to as resource impact, is the financial change in the use of health resources associated with adding a new drug to a formulary or the adoption of a new health technology. Several national and transnational organizations worldwide have updated their BIA guidelines in the past 4 years. The aim of the present review was to provide a comprehensive list of the key recommendations of BIA guidelines from different countries that may be of interest for those who wish to build or to update BIA guidelines.MethodsNational and transnational BIA guidelines were searched in databases including MEDLINE, EMBASE, Cochrane, EconLit, CINAHL, Business Source Premier, HealthSTAR, and the gray literature including regulatory agency websites. Data were reviewed and abstracted based on key elements in a standard BIA model (analytical model structure, input and data sources, and reporting format).ResultsEight national (Australia, UK, Belgium, Ireland, France, Poland, Brazil, and Canada) and one transnational (International Society for Pharmacoeconomics and Outcomes Research) BIA guidelines were included in this review, and a comprehensive list of BIA recommendations was identified. The review showed that certain recommendations such as patient population assessment, drug-related direct costs, discounting, and disaggregated results were common across the various jurisdictions. BIA guidelines differed from each other in terms of the number and scope of recommendations, the terminology used (eg, the definition of comparators or cost offsets) and the direction of the recommendations (ie, to include or not to include with respect to such items as off-label indications, indirect costs, clinical outcomes, and resource utilization).ConclusionWhile there was a common purpose for all of the BIA guidelines that were identified, substantial differences did occur in the specific recommendations. The pharmaceutical financing system structure might explain why guidelines from the UK, Australia, and Canada have more country-specific recommendations. The desire to be consistent with adopted economic evaluation assumptions might be another reason for some observed differences between countries. Further research is required to assess the source of the heterogeneity between BIA recommendations are identified in different guidelines.

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Section: Supplementary Materialsmentioning

confidence: 99%

A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new drug submissions

Foroutan¹,

Tarride²,

Xie³

et al. 2018

CEOR

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“…Likewise, several jurisdictions have specific requirements for BIA often adapted from the ISPOR guidelines and interpreted to fit their principles (Marshall et al, 2008;Ferreira-Da-Silva et al, 2012;Neyt et al, 2015;Mauskopf and Earnshaw, 2016;Foroutan et al, 2018;Ghabri and Mauskopf, 2018;HIQA, 2018;Foroutan et al, 2019). In spite of these standardizing efforts, BIA are often found to be simplistic, incomplete, inconsistent and poorly designed (Mauskopf et al, 2005;Orlewska and Gulacsi, 2009;van de Vooren et al, 2014;Faleiros et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

“…In spite of these standardizing efforts, BIA are often found to be simplistic, incomplete, inconsistent and poorly designed (Mauskopf et al, 2005;Orlewska and Gulacsi, 2009;van de Vooren et al, 2014;Faleiros et al, 2016). This inaccurate and nontransparent portrayal of BIA complicates inter-and intranational BIA comparison but could especially lead to misinformed resource allocation while potentially disadvantaging the availability of unconventional treatments like orphan drugs (Orlewska and Mierzejewski, 2004;Marshall et al, 2008;Ferreira-Da-Silva et al, 2012;Neyt et al, 2015;Ghabri and Mauskopf, 2018;HIQA, 2018;Foroutan et al, 2019).…”

Section: Introductionmentioning

confidence: 99%

Methodological Quality Assessment of Budget Impact Analyses for Orphan Drugs: A Systematic Review

et al. 2021

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Objectives: This research aims to evaluate the methodological quality of budget impact analyses for orphan drugs and to provide suggestions for future analyses.Methods: Conference abstracts and peer-reviewed literature on budget impact analyses were collected through searches of Pubmed and Embase. ISPOR good practice guidelines were used as a methodological standard for budget impact analyses. Examined parameters encompassed: perspective, target population, data sources, intervention and comparator(s), time horizon, scope of costs, discounting, validation, assumptions and sensitivity analysis.Results: Seventy studies on individual orphan drugs and 21 studies on a combination of orphan drugs analyzing budget impact were identified. Overall, analyses considered a third-party payer perspective, reported periodic budget impacts over a one-to-five-year time horizon, and did not apply discounting. A dynamically fluctuating population and costs beyond drug costs were accounted for in 18.7% and 51.7% of studies, respectively. Input data were retrieved from published literature, clinical trials, registries, claims databases, expert opinions, historical data and market research. Assumptions were mostly made about population size and intervention/comparator(s) market uptake, but these assumptions were rarely justified and their impact was insufficiently explored through sensitivity analyses. Budget impact results were rarely validated.Conclusion: Existing budget impact analyses for orphan drugs are concise, vary greatly and are of substandard methodological quality. To eliminate possible bias in future budget impact analyses, future studies should adhere to national or ISPOR good practice guidelines on budget impact analysis.

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“…Other countries, for example The Netherlands, France and Australia, do have guidance or even legislation on BI, but the actual role of BI or the impact on decision-making remains rather informal and, moreover, politically driven [1–4]. On the other end of the spectrum, England has one of the best defined systems with a clear role for BI in healthcare decision making [2, 3]. In general, however, there is an informal role for BI and its contribution to reimbursement decisions often remains unclear.…”

Section: Introductionmentioning

confidence: 99%

Accuracy of budget impact estimations and impact on patient access: a hepatitis C case study

et al. 2019

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Background High budget impact (BI) estimates of new drugs limit access to patients due to concerns regarding affordability and displacement effects. The accuracy and methodological quality of BI analyses are often low, potentially mis-informing reimbursement decision making. Using hepatitis C as a case study, we aim to quantify the accuracy of the BI predictions used in Dutch reimbursement decision-making and to characterize the influence of market-dynamics on actual BI. Methods We selected hepatitis C direct-acting antivirals (DAAs) that were introduced in the Netherlands between January 2014 and March 2018. Dutch National Health Care Institute (ZIN) BI estimates were derived from the reimbursement dossiers. Actual Dutch BI data were provided by FarmInform. BI prediction accuracy was assessed by comparing the ZIN BI estimates with the actual BI data. Results Actual BI, from 1 Jan 2014 to 1 March 2018, was €248 million whilst the BI estimates ranged from €388–€510 million. The latter figure represents the estimated BI for the reimbursement scenario that was adopted, implying a €275 million overestimation. Absent incorporation of timing of regulatory decisions and inadequate correction for the introduction of new products were main drivers of BI overestimation, as well as uncertainty regarding the patient population size and the impact of the final reimbursement decision. Discussion BI in reimbursement dossiers largely overestimated actual BI of hepatitis C DAAs. When BI analysis is performed according to existing guidelines, the resulting more accurate BI estimates may lead to better informed reimbursement decisions. Electronic supplementary material The online version of this article (10.1007/s10198-019-01048-z) contains supplementary material, which is available to authorized users.

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The use of budget impact analysis in the economic evaluation of new medicines in Australia, England, France and the United States: relationship to cost-effectiveness analysis and methodological challenges

Cited by 23 publications

References 8 publications

A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new drug submissions

A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new drug submissions

Methodological Quality Assessment of Budget Impact Analyses for Orphan Drugs: A Systematic Review

Accuracy of budget impact estimations and impact on patient access: a hepatitis C case study

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