Journal
GENETICS IN MEDICINE
Volume 16, Issue 3, Pages 251-257Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/gim.2013.122
Keywords
cost-effectiveness; economic value; ethical/legal/social implications (ELSI); genetic tests; personalized medicine
Categories
Funding
- National Cancer Institute [P01CA130818]
- National Human Genome Research Institute [R01HG007063]
- Department of Clinical Pharmacy, University of California, San Francisco
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Purpose: There is uncertainty about when personalized medicine tests provide-economic value. We assessed evidence on the economic value of personalized medicine tests and gaps in the evidence base. Methods: We created a unique evidence base by linking data on published cost-utility analyses from the Tufts Cost-Effectiveness Analysis Registry with data measuring test characteristics and reflecting where value analyses may be most needed: (i) tests currently available or in advanced development, (ii) tests for drugs with Food and Drug Administration labels with genetic information, (iii) tests with demonstrated or likely clinical utility, (iv) tests for conditions with high mortality, and (v) tests for conditions with high expenditures. Results: We identified 59 cost-utility analyses studies that examined personalized medicine tests (1998-2011). A majority (72%) of the cost/quality-adjusted life year ratios indicate that testing provides better health although at higher coat, with almost half of the ratios falling below $50,000 per quality-adjusted life year gained. One-fifth of the results indicate that tests may save money. Conclusion: Many personalized medicine tests have been found to be relatively cost-effective, although fewer have been found to be cost saving, and many available or emerging medicine tests have not been evaluated. More evidence on value will be needed to inform decision making and assessment of genomic priorities.
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