Mar. 24--Use of a genetic test could significantly reduce hospital stays as well as health care costs for about 2 million U.S. patients who start taking a top blood thinning drug at any given time.
That's what a recent study by Mayo Clinic and Medco Health Solutions, Inc. found when looking at the efficiency of genotyping patients starting to take the drug warfarin, commercially called Coumadin and other brand names.
Adjusting warfarin's dosage for a patient just starting to take it has always been a difficult process requiring many blood tests, officials say.
"It has been a conundrum for physicians for about 50 years, as long as warfarin has been out there," says Dr. Thomas Moyer of Mayo Medical Labs. "There are four significant factors for that including age, race, cold medication and genetic variations."
Mayo Clinic developed a pair of genetic tests to determine warfarin dosage that have been available to doctors for two years. However, clinical guidelines do not recommend that the testing be done and Medicare does not reimburse for the costs of the $350 test.
The Mayo Clinic/ Medco study, released at an annual meeting of the American College of Cardiology, last week, found that the genetic tests could reduce hospital stays of new warfarin users by about 40 percent.
While use of the tests are growing, fewer than 2 percent of patients starting to take warfarin are tested genetically, says Dr. Robert Epstein, Medco's chief medical officer.
"We discovered 22 percent of patients end up in the hospital in first six months on warfarin," he said of the study, which genotyped 896 patients for alterations in their specific genes.
Those patients' dosages were adjusted depending on the results of those tests. How they fared with the drug was compared with 2,688 patients whose warfarin doses were managed using standard methods like an $80 International Normalized Ratio (INR) blood test.
To keep the results as balanced as possible, no patients in Olmsted County were part of this study, said Moyer.
Epstein says the results of the study show using the tests can accomplish what many are asking of U.S. health care these days -- better results for lower costs.
"If we are able to avoid two hospitalizations out of 100 patients, that would completely underwrite the cost of genotyping all 100 patients," he says.
Moyer points out that a head CT scan is typically done to check for signs of stroke on a patient who goes into the emergency room with problems due to warfarin. That scan costs between $4,000 to $5,000.
Medco did the study with Mayo Clinic and Washington University.
Medco manages the largest mail order pharmacy operations in the U.S. Through its corporate clients, it covers 60 million people. About one-third of the Fortune 500 list of top companies are clients of Medco.
While Mayo Clinic and Medco believe the study clearly shows the value of the testing, one physician at the American College of Cardiology issued a statement critical of it.
Dr. Mandeep Mehra, chief of cardiology at the University of Maryland Medical Center, said he believes it should have been a double blind clinical study.
He wrote that he did not believe the study adequately adjusted the findings to account for doctors caring for the patients in the study more carefully.
In an article by GenomeWeb Daily News, Mehra was quoted as stating that the positive results were "...More likely the effect of [doctors paying] closer attention to their patients by sending them a piece of paper that asked them to change their dosing schedule, or consider changing their dosing schedule."
In response, Epstein says the study was set up to be "...A more naturalistic study reflecting how this is used in the real world." He added that the group was aware of multiple other clinical studies in the works that are following the more stringent scientific parameters.
Mayo's Moyer added that the well-respected Mehra had not seen the full study when he wrote his response. His criticism was based solely on the presentation at the American College of Cardiology.
Epstein said he felt confident about the results of the Mayo Clinic-Medco study.
The research collaboration now plans to follow up this study with one that looks just at the economic results of using genetic tests in connection to warfarin dosing.
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