Centers for Medicare and Medicaid Services Say More Research on Warfarin Tests Necessary
Warfarin is a widely-used drug that prevents blood clots during surgery. Two million patients a year take it, but doctors must calibrate dosing carefully to prevent bleeding complications from the blood thinner. Fortunately, the Food and Drug Administration last year approved a genetic test can help physicians prevent adverse responses. The test, which costs up to $500, could potentially lead to other health-care savings by leveraging personalized medicine to reduce the number of problems that result from improper dosing.
But the Centers for Medicare and Medicaid Services recently released their “Proposed Decision Memo for Pharmacogenomic Testing for Warfarin Response,” in which they write that genetic testing does not improve “health outcomes in Medicare beneficiaries” when trying to predict responsiveness to the anticoagulant.
However, CMS did decide to pursue a strategy known as “coverage with evidence development,” which is authorized under the Social Security Act. This means that CMS will cover the cost of genetic tests for warfarin responsiveness if they are a part of a “prospective, randomized, controlled clinical trial.” In short, CMS will cover more research on use of the genetic test, but not pay for it in clinical settings.
According to GenomeWeb, private insures such as Aetna have also chosen not to cover the tests and have not been moved by the CMS decision to cover them for clinical trials.
Overall, this is a sensible policy and CMS lays out clear reasoning for it. Out of the six professional societies that provided their positions on pharmacogenomic testing for warfarin dosing, only two, the American Association for Clinical Chemistry and the College of American Pathologists, felt that there was sufficient evidence of effectiveness to warrant coverage. CMS also incorporated five expert opinions into their decision, all of which attested that the evidence regarding real-world health outcomes was insufficient. Michael Brophy of the Department of Veterans Affairs Diagnostic Services wrote that the genetic factors influencing response to the drug did not make a practical difference in clinical situations: “It’s only one of many factors that determine the appropriate dose.”
This decision is likewise important because it answers questions raised at a Medicare Evidence Development and Coverage Advisory Committee meeting in February on diagnostic genetic testing, which tests for diseases or anticipates drug response in patients. Most of the committee members felt that diagnostic genetic testing should be held to similar standards and criteria as other forms of diagnostic testing. The committee also emphasized that in order to assess the impact of diagnostic genetic testing on patient-centered health outcomes, there need to be “methodologically rigorous” evidence gathered on direct patient-centered health outcomes such as “mortality, functional status, and adverse events.”
If anything, these evaluations all to point to the need for robust evidence gathering. Personalized medicine will further require a sophisticated infrastructure for collecting, analyzing, and coordinating clinical and research information, and that necessitates investment in health information technology and comparative effectiveness research to reduce costs and improve health care outcomes.
Comments on this article
By clicking and submitting a comment I acknowledge the Science Progress Privacy Policy and agree to the Science Progress Terms of Use. I understand that my comments are also being governed by Facebook's Terms of Use and Privacy Policy.
