Personalized Genetic Test Info Added To Warfarin Drug Labeling
This article was originally published in The Gray Sheet
FDA is updating the label for the anti-clotting drug warfarin to inform physicians and patients about the usefulness of genetic testing before beginning therapy, but the agency will wait for data from ongoing studies of the tests before adding stronger recommendations for the tests
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The overall message of three trials published recently in The New England Journal of Medicine: “This pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or, at best, marginal usefulness, given the cost and effort required to perform this testing,” according to an editorial also in NEJM.
CMS wants more evidence that genetic testing of individuals' responsiveness to the blood thinner warfarin actually improves health outcomes in Medicare populations, and the agency is using the national coverage process to call for randomized clinical trials
Under a CMS proposal, genomic testing to predict warfarin response would receive Medicare coverage in the context of a clinical trial comparing the frequency of five kinds of adverse events with and without the tests.