Biotechnology Healthcare - July/August 2008 - (Page 55)

PERSONALIZED MEDICINE One study estimated that integrating genetic testing into warfarin therapy could save more than $1 billion a year in adverse event-related spending. Michael D. Caldwell, MD, PhD, a vascular surgeon and and 17,000 strokes annually. We estimate the reduced director of the wound healing program at the Marshfield healthcare spending from integrating genetic testing into Clinic, in Marshfield, Wis. In February, Caldwell and colwarfarin therapy to be $1.1 billion annually.” leagues published an article in Blood 1 describing their discovery of a new cytochrome P450 genetic variant, CYPNOT “FAR-OUT SCIENCE” 4F2, that accounted for a difference in stable warfarin dose Potential savings notwithstanding, integrating genetic of about 1 milligram per day in three independent cohorts testing into routine warfarin therapy may take a while. For of patients. one thing, studies of warfarin genetic markers have all “The addition of the CYP4F2 explains only about 2 adbeen retrospective. Several prospective studies — the gold ditional percent of the interindividual variability in therstandard for demonstrating that an intervention results in apeutic dose in the population as a whole, but it can make improved health outcomes — are planned or under way. a huge difference in people who have the variant,” CaldFDA’s Critical Path Initiative and the National Heart, well explains. “A person with full enzyme function gets Lung, and Blood Institute are planning a prospective clinian average dose of 5 milligrams per day, so 1 cal trial that will study warfarin dosing based on milligram amounts to a 20 percent difference.” genetic test information. Critical Path also is Last November, Marshfield Clinic licensed helping to finance two other projects — one, a the new 4F2 warfarin biomarker to Pasadena, clinical study by Harvard Partners that will deCalif.-based Osmetech Molecular Diagnostics. velop personalized dosing algorithms for paOsmetech already has an FDA-cleared cystic fitients newly started on warfarin, and the other, a brosis test on the market, and CEO James White research project by the University of Utah and the expects FDA clearance of its new eSensor warCritical Path Institute of Tucson, Ariz., to defarin sensitivity test by the middle of this year. velop genetically based dosing instructions. The test will run on Osmetech’s patented XT-8 Michael D. Caldwell says that Marshfield Clinic is halfway platform, and it will include the CYP2C9 *2, *3, Caldwell, MD, through a prospective trial funded by the Agency and VKORC1 markers. A second version of the PhD, founded for Healthcare Research and Quality. warfarin sensitivity test is being developed that the nationally Medco Health Solutions, the large pharmacy includes CYP4F2 and other important markers acclaimed benefit manager, is collaborating with Mayo to address interindividual variability. Clinic’s Mayo Collaborative Services to evaluate Personalized “Our belief is that it’s in everyone’s interest to Medicine Repatient safety and financial savings derived from get to a standard of care that is an improvement search Project at the use of genetic testing for warfarin dosing. The over where we are today,” says White. “We’re Marshfield Clinic, study has enrolled more than 1,000 patients who certainly trying to get across the improved lev- in Wisconsin. are new to warfarin therapy and who will receive care in community settings. els of patient care that this test will provide, the Teresa M. DeLuca, MD, MBA, vice president cost-effectiveness of having fewer patients turning up at ERs with adverse drug reactions, and shortenin Medco’s Department of Personalized Medicine, is the ing the time it takes to get them on the right dosage. These principal investigator of the Mayo/Medco study. Although kinds of things should have significant benefits to payer she believes the jury is still out on CYP4F2, she says early results from Medco’s collaboration with Mayo suggest and employer groups.” The resulting cost savings should significant gains in safety and efficacy. also be good news for healthcare providers whose payment is capitated or case based. “This is not far-out science,” DeLuca adds. “Genotyping gives you the ability to use information that you can gather A 2006 paper by the AEI-Brookings Joint Center for painlessly, easily, and not that expensively; that actually will Regulatory Studies, “Health Care Savings from Personalizing Medicine Using Genetic Testing: The Case of [result in] true cost savings; and, for the patient, adds safety Warfarin,” estimates that “Formally integrating genetic and efficacy. We take this technology very seriously, and testing into routine warfarin therapy could allow Ameriwe stand behind this as the way medicine needs to be practiced.” can warfarin users to avoid 85,000 serious bleeding events 1 Caldwell MD, Awad T, Johnson JA, et al. CYP4F2 genetic variant alters required warfarin dose. Blood. 2008;111:4106–4112. Bob Carlson, MHA, writes exclusively about healthcare. He lives near Zionsville, Ind. JULY/AUGUST 2008 · BIOTECHNOLOGY HEALTHCARE 55

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.