B. Decision tree for budget scenario with drug E
11.2 Reporting the Budget-Impact Analysis
11.2.8 Reporting the Results of a Combined Cost-Effectiveness
Although the focus of this book is on budget-impact analysis, as mentioned in Chap.
7, budget-impact analyses may be developed in combination with cost-effectiveness analyses using the same computer program. There are several efficiencies with this approach:
• Many of the same model assumptions and inputs are used for both models. These include the drug- and condition-related costs and efficacy and safety of current and new drugs.
• Some outputs from the cost-effectiveness model might be needed as inputs for the budget-impact model, for example, the changes in condition-related symptoms and/or clinical events over time after beginning treatment with different drugs.
• There is convenience in having both calculations performed using a single piece of software.
A combined cost-effectiveness/budget-impact computer model will need to clearly report the model structure, structural assumptions, input values, and results for both the cost-effectiveness analysis and the budget-impact analysis. All compo- nents for both analyses need to be presented so that the reader can easily understand both analyses. This can be achieved by developing this type of model in modular format. Clearly, where the same input values are used for both types of analyses, they need only to be provided once. But all the additional input parameter values needed in a budget-impact analysis (population size and relevant descriptors, condi- tion severity mix, and current and estimated treatment mixes with and without the new drug) should be presented in tables and denoted as specific to the budget-impact analysis. A description of how the model structure and assumptions are used for the budget-impact analysis can be presented separately or presented such that it is easy for the reader to understand how these components were adapted from the cost- effectiveness analysis to provide estimates of the budget impact. Since dossiers and journals typically allow for supplemental appendices of any length, there is no rea- son to abbreviate the reporting of either the cost-effectiveness or budget-impact model to meet dossier or journal page limits.
Exercises
Exercise 11.1 Obtain a presentation of a budget-impact analysis from the peer- reviewed literature. Compare the reporting of this analysis with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement checklist (Husereau et al. 2013). How well did this publication follow the checklist?
Exercise 11.2 Using the publication obtained in Exercise 11.1, critically evalu- ate each component within the title and abstract. What components of the checklist did the publication include and exclude?
11 Reporting Budget-Impact Analyses
Exercise 11.3 Using the publication obtained in Exercise 11.1, critically evalu- ate each component within the methods. What components of the checklist did the publication include and exclude?
Exercise 11.4 Using the publication obtained in Exercise 11.1, critically evalu- ate each component within the results. What components of the checklist did the publication include and exclude?
Exercise 11.5 A budget-impact analysis was created for a health plan. The parameters, their values, and sources included in the analysis and results are pre- sented in the tables below. Write an abstract and title for this budget-impact analysis such that it follows the CHEERS guidance.
Inputs
Parameter Value Source
Health plan population 1 million lives Known with certainty by health plan
Incidence of condition 1% Published literature
Percentage of patients with condition who are treated
90% Known with certainty by health plan Current market share
Drug 1 50% Manufacturer estimate
Drug 2 50% Manufacturer estimate
New drug 0% Manufacturer estimate
Projected market share: year 1
Drug 1 45% Manufacturer estimate
Drug 2 45% Manufacturer estimate
New drug 10% Manufacturer estimate
Drug cost
Drug 1 $100 Known with certainty by health plan
Drug 2 $125 Known with certainty by health plan
New drug $150 Known with certainty by health plan
Hospitalization costs $1000 Published literature
Hospitalizations per year
Drug 1 2.00 Published literature
Drug 2 1.75 Published literature
New drug 1.50 Published literature
Results
Costs/outcomes
Budget scenario without new
drug Budget scenario with new drug
Drug costs $1,012,500 $1,046,250
Other medical costs $16,875,000 $16,537,500
Total costs $17,887,500 $17,583,750
Hospitalizations 16,875.00 16,537.50
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Exercise 11.6 Given the budget-impact analysis presented in Exercise 11.5, write a Methods section for a report such that it follows the CHEERS guidance.
Exercise 11.7 Given the budget-impact analysis presented in Exercise 11.5 and an alternative set of values for various parameters as outlined below, write a Results section for a report such that it follows the CHEERS guidance.
Parameter Current value New value
Health plan population 1 million lives 2 million lives
Incidence of condition 1% 0.5%
Percentage of patients with condition who are treated
90% 85%
Current market share
Drug 1 50% 45%
Drug 2 50% 55%
New drug 0% 0%
Projected market share: year 1
Drug 1 45% 40%
Drug 2 45% 40%
New drug 10% 20%
Drug cost
Drug 1 $100 $125
Drug 2 $125 $150
New drug $150 $150
Exercise 11.8 Assume that the budget-impact analysis as outlined in Exercise 11.5 was constructed for a population within the United States. This analysis now needs to be adapted for use in the United Kingdom. Discuss how the inputs and results would change and how reporting of this updated analysis would be presented with respect to the title/abstract, methods, and results.
Exercise 11.9 Discuss the importance of reporting budget-impact analyses and why following a guidance document is useful. What may be some disadvantages of following guidances?
Exercise 11.10 Results of a budget-impact analysis are presented in Box 11.10.
How else might the results of this budget-impact analysis be presented? What other types of results could be presented? Write a report presenting these results along with tabular and graphical presentations of the results.
References
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11 Reporting Budget-Impact Analyses
Bajaj PS, Veenstra DL, Goertz HP, Carlson JJ. Targeted erlotinib for first-line treatment of advanced non-small cell lung cancer: a budget impact analysis. J Med Econ. 2014;17(8):538–46. doi:10 .3111/13696998.2014.912987.
Caro JJ, Huybrechts KF, Xenakis JG, O’Brien JA, Rajagopalan K, Lee K. Budgetary impact of treating acute bipolar mania in hospitalized patients with quetiapine: an economic analysis of clinical trials. Curr Med Res Opin. 2006;22(11):2233–42.
Centers for Medicare and Medicaid Services. Physician fee schedule and acute inpatient prospective payment system. http://www.cms.hhs.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage and http://www.cms.hhs.gov/Acutelnpatient PPS/. Accessed 18 Oct 2006. Cited in: Danese et al.
2008.
Danese MD, Reyes C, Northridge K, Lubeck D, Lin CY, O’Connor P. Budget impact model of adding erlotinib to a regimen of gemcitabine for the treatment of locally advanced, nonresect- able or metastatic pancreatic cancer. Clin Ther. 2008;30(4):775–84.
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, CHEERS Task Force, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.
Value Health. 2013;16(2):e1–5. doi:10.1016/j.jval.2013.02.010.
International Agency for Research on Cancer. Cancer incidence in five continents, vol. IX. Lyon:
World Health Organization; 2007 . Cited in: Bajaj et al. 2014.
Mauskopf J, Mullins D, Earnshaw S. Budget impact analysis: a six step process. A cost course presented at the 21st International Conference of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Washington, DC, 2016.
Mauskopf J, Muroff M, Gibson PJ, Grainger DL. Estimating the costs and benefits of new drug therapies: atypical antipsychotic drugs for schizophrenia. Schizophr Bull. 2002;28(4):619–35.
Rứnborg SM, Svendsen UG, Micheelsen JS, Ytte L, Andreasen JN, Ehlers L. Budget impact analy- sis of two immunotherapy products for treatment of grass pollen-induced allergic rhinocon- junctivitis. Clinicoecon Outcomes Res. 2012;4:253–60. doi:10.2147/CEOR.S34832.
Sullivan SD, Mauskopf JA, Augustovski F, Caro JJ, Lee KM, Minchin M, et al. Budget impact analysis—principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014;17(1):5–14. doi:10.1016/j.jval.2013.08.2291.
Taylor DCA, Chu P, Rosen VM, Baker CL, Thompson D. Budgetary impact of varenicline in smoking cessation in the United Kingdom. Value Health. 2009;12(1):28–33.
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J. Mauskopf et al., Budget-Impact Analysis of Health Care Interventions, DOI 10.1007/978-3-319-50482-7_12
Chapter 12
Additional Pragmatic Topics
Stephanie Earnshaw and Josephine Mauskopf
Abstract A variety of pragmatic issues can come up when developing budget- impact analyses. Some of these issues can have a substantial impact on drug budgets and can reverse the expected results. Therefore, payers and budget holders may require the consideration of some of these issues in the main analyses. In this chap- ter, we review three common pragmatic issues: (1) off-label drug use, (2) the impact of adherence and/or persistence, and (3) the importance of understanding the cost perspective. All of these issues should be carefully considered when developing budget-impact analyses for new drugs.
Keywords Budget-impact analysis • Off-label use • Adherence • Persistence
• Costs • Accounting • Revenue
Chapter Goal
To provide an overview of three additional topics that might need to be con- sidered when performing a budget-impact analysis: (1) whether and how to include off-label usage with current treatments and the new drug, (2) how to account for adherence and persistence to the new and current drugs, and (3) consideration of the type of costs to use within a budget-impact analysis.
S. Earnshaw (*) • J. Mauskopf
RTI Health Solutions, RTI International, Research Triangle Park, Durham, NC, USA
e-mail: searnshaw@rti.org
In this chapter, we consider three additional topics that might need to be consid- ered when designing a budget-impact analysis.1 These are the inclusion of off-label drugs, the effect of adherence and persistence to treatment on the budget-impact estimates, and selection of appropriate costs to include such as fixed or variable costs, charges, or reimbursement rates.