Implementing and Evaluating Genomic Screening Programs in Health Care Systems Proceedings of a Workshop (2018) / Chapter Skim
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3 Financial Considerations for Implementing Genomics-Based Screening Programs
3 Financial Considerations for Implementing Genomics-Based Screening Programs
Pages 33-52
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From page 33... ...
, but this is not captured by traditional approaches to cost effectiveness. When this knowledge (i.e., personal utility)
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Bradford Powell, an assistant professor in the Department of Genetics at the University of North Carolina at Chapel Hill, provided an overview of the economic issues related to the implementation of genomics-based screening programs. Josh Peterson, an associate professor of biomedical informatics and medicine at Vanderbilt University Medical Center, described two ongoing programs to illustrate the drivers of value for pharmacogenomics panel testing.
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less than the benefits • Costs balanced against the benefits SOURCES: Bradford Powell, National Academies of Sciences, Engineering, and Medicine workshop presentation, November 1, 2017. Adapted from Wilson and Jungner, 1968.
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? The question of what results should be returned when healthy infants undergo genomic screening has been incorporated as part of the North Carolina Newborn Exome Sequencing for Universal Screening (NC Nexus)
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Another part of the study randomizes parents into two groups which are then asked to decide whether they want to receive genomic screening information: those parents whose child screens positive for a pediatric-onset condition with a low actionability score, and those whose child screens positive for an adult-onset condition with a higher actionability score.4 4 For more information about parental decision making about newborn genomic screening, see http://pediatrics.aappublications.org/content/137/Supplement_1/S16 (accessed January 18, 2018)
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Because health care in the United States uses a third-party payer system, there are different potential incentives to participate in genomic screening programs. Ideally, genomic screening programs should result in better patient care.
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are the best characterized to date, although the cost of returning results is likely to change as current genomic screening efforts expand to populationlevel screening. Downstream costs include provider education, confirmatory testing, interventions and surveillance, and complications of interventions or surveillance.
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6 and an accompanying cost-effectiveness study designed to determine the long-term value of pharmocogenomic panel testing, Rational Integration of Genomic Healthcare Technology (RIGHT) .7 Multiplex Pharmacogenomic Screening Panel The typical testing approach at Vanderbilt University Medical Center has been evolving from serial, single gene testing to multiplexed panel testing.
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From page 41... ...
To help with this, patients are also informed of their pharmacogenomic results through the patient portal, which provides high-level information about their pharmacogenetic test results and about how their genes affect their medications. Determining the Value of Pharmacogenomic Testing There are several lessons that have informed the economic modeling of pharmacogenomic screening, Peterson said.
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From page 42... ...
is a left ventricular assist device, where the ICER exceeds $500,000; an example of a low incremental cost-effectiveness ratio is a colonoscopy, where patients gain an extra QALY for every $25,000 spent on the intervention. In this analysis, preemptive genotyping has a 50 percent chance of being cost effective relative to a willingness to pay of $150,000, although many groups set willingness to pay thresholds at $50,000 or $100,000, Peterson shared.
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From page 43... ...
A sensitivity analysis that plots the probability that pharmacogenomic information is used versus risk reduction from use of the pharmacogenomic-guided therapy is another way to analyze cost effectiveness of multiplexed testing strategies, Peterson said. If there is no reduction of the risk of an adverse event, then not testing is clearly preferred.
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The reference case in Canada and the United Kingdom is the health system perspective -- that is, the perspective of those who manage the budgets and need to meet the objective of maximum health gains across the population. The recently published guidance from the Second Panel on Cost Effectiveness in Health and Medicine for the United States takes this analysis a step further, calling for the inclusion of the societal perspective as well as the health care system perspective (Neumann et al., 2017)
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For precision medicine and genomics, Grosse and colleagues have said that personal utility is the utility that individuals and families ascribe to genomic information apart from health outcomes (Grosse et al., 2010)
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, Regier adapted the ICER equation to calculate net monetary benefit and include personal utility using willingness to pay. His model projected life expectancy and costs for two trajectories: one for an individual who received standard care for CRCP, and another for an individual who received a genomic screening panel and was given the secondary findings.
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, Regier finds that the probability that CRCP screening and the return of secondary findings is cost effective to be 72 percent, which may be too much uncertainty for the typical decision maker in Canada or the United Kingdom, he said. When the concepts of personal utility and net benefit were incorporated, decision uncertainty was reduced.
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Randomized controlled trials in precision medicine will not be common or broad in scale. Perspectives on Costs It was observed that the costs of conducting panel-based preemptive testing are likely to vary over time, and a workshop participant asked how reductions in the cost of testing influence overall cost effectiveness and who bears these costs.
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From page 49... ...
For example, if a retrospective economic analysis shows a certain number of actionable variants but in practice only a portion of those are actually being acted on, how can that information be accounted for in the economic analysis? How can the message be delivered to providers that improvement in clinical practice to achieve optimal use, or even appropriate use, could provide a greater cost effectiveness?
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Socioeconomic status, including income, geography, and age, affect preferences and personal utility, Regier agreed. Better communication and decision aids are needed to help people make very complex decisions about what information they want.
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Once there has been a commitment to conduct the original genomic test, the incremental cost for adding several additional tests would seem to be quite small, Feero said. Decision Tools It is challenging for providers to determine which panel will provide the most benefit for the patient from the many different panels available, a workshop participant commented.
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From page 52... ...
A standardized cost can be attached to that clinical outcome, which has some transferability across health care systems. There is a movement toward embedding health economics within many genome-scale sequencing projects, Powell said, adding that this movement should be encouraged and mentioning the National Human Genome Research Institute's Ethical, Legal and Social Implications Research Program.
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