The Economics of Genomic Medicine Workshop Summary (2013) / Chapter Skim
Currently Skimming:
7 Panelists' and Stakeholders' Perspectives
7 Panelists' and Stakeholders' Perspectives
Pages 59-72
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From page 59... ...
• A major hurdle to genomic-based medicine is the lack of a national, dynamically updated, interpretative database of evi dence for the clinical utility of genetic variants. • Patients need time with their physicians to discuss options, but incentives are currently not aligned well to encourage this time.
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From page 60... ...
These decisions also need to maximize equity, though absolute equity is impossible. Existing medical tests are not used in what Evans called "shotgun or nontailored" ways, and genomic tests should not be treated differently.
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From page 61... ...
The true impact of genomics may lie in preventing the use of unnecessary tests rather than in linking any particular single nucleotide polymorphism to a disease or in determining how a whole genome sequence is used, said Armstrong. A CHIEF SCIENTIFIC OFFICER'S PERSPECTIVE Whole genome or exome sequencing is initially entering clinical practice informally via academic medical centers and biotechnology laboratories operating under guidelines from the Clinical Laboratory Improvement Amendments (CLIA)
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From page 62... ...
Such a system would have complex intended uses, accuracy problems, no gold standard for comparison, rapid technical obsolescence, and a potential requirement for lengthy and costly prospective treatment-by-genotype clinical outcome studies. In addition, it is difficult for manufacturers that have to produce a system with validated reagents and software to compete with laboratories that develop tests under CLIA that use research-use-only instruments and that can update software and reagents as needed.
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. A PATIENT'S PERSPECTIVE Patients tend to differ from patient advocates, said Mary Lou Smith, cofounder of the Research Advocacy Network.
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Viewed broadly, public health provides the following essential services: • Monitoring health status to identify and solve community health problems. • Diagnosing and investigating health problems and health hazards in the community.
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For example, teaching hospitals provide a large amount of care without reimbursement, whether through caring for indigent patients or by paying for promising innovations so that they can be developed to the point of reimbursement. Hospitals have been deciding how much to invest in new genomic technologies for many years, but the situation is now beginning to change dramatically, according to Pardes.
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From page 66... ...
For example, Columbia Presbyterian and Weill Cornell have focused on colorectal cancer, which represents about threequarters of the gastrointestinal malignancies seen at the hospitals, Pardes said. They are using sequencing technology and bioinformatics to analyze about 50 genes identified as having the greatest potential impact on clinical care.
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From page 67... ...
Even where a test has very little demonstrated clinical utility, a provider may prescribe it, and a patient may agree. Ramsey pointed out that cost-effectiveness is not a perfect tool for informing decision making, but it is a better tool than the system currently has to determine resource allocation.
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These advocacy groups "see families become bankrupt or [living] in severe financial straits being talked into very expensive therapies that actually offer very modest benefit," said Ramsey.
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Nevertheless, the time may be right today for manufacturers to place greater reliance on this sort of model. Ramsey pointed out that coverage with evidence development requires the collection of evidence, but, he said, "I would argue that we have the data." Insurance claims are available that contain information on costs and outcomes, and electronic medical records in the near future will cover most patients.
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In addition, evidence thresholds are needed to determine at what point patients, physicians, and payers are willing to act on the basis of the evidence in hand, said Veenstra. ADDITIONAL ISSUES A participant pointed out that molecular diagnostic testing is being conducted largely in academic medical centers and not in community hospitals, where most cancer patients get care, particularly minority patients.
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From page 71... ...
He also noted that better infrastructure is needed to measure economicrelated outcomes in addition to traditional measures. Electronic medical records systems need to anticipate the need for the eventual integration of genomic information so that downstream outcomes can be captured.
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Do accountable care organizations pro I vide a possible mechanism for more efficient health care delivery of genomic technologies? • tudy of provider preferences for provision of genomic medicine -- S evaluation of barriers to implementation.
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