DESCRIPTION
Genetic testing to determine the KIF6 Trp719Arg variant status of patients is being evaluated as a prognostic test to predict risk of future cardiovascular events and as a pharmacogenetic test to predict response to statin therapy, particularly in high-risk patients.
The KIF6 genotyping test is not a manufacturer test kit. It is a laboratory-developed test (LDT), offered by clinical laboratories licensed under Clinical Laboratory Improvement Amendments (CLIA) for high-complexity testing. Laboratories that conduct genetic testing must comply with the provisions of the CLIA, which is administered by the Health Care Financing Administration (HCFA) and the Centers for Disease Control and Prevention (CDC).
POLICY
KIF6 genotyping for predicting cardiovascular risk and/or the effectiveness of statin therapy is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The literature that is currently available is limited and contradictory regarding outcomes. There is a lack of controlled studies in the published literature to evaluate the clinical importance of KIF6 genotyping to predict clinical events and, thus, be used to alter the treatment of individuals.
SOURCES
Allingham-Hawkins, D. Lea, A., & Levine, S. (2010). KIF6 p. Trp719Arg testing to assess risk of coronary artery disease and/or statin response. PLOS Currents, 2010, (2). Retrieved March 21, 2011 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2959200/. (Level 2 Evidence - Independent study)
Arnett, D. K., Baird, A. E., Barkley, R. A., Basson, C. T., Boerwinkle, E., Ganesh, S. K., et al. (2007, May). Relevance of genetics and genomics for prevention and treatment of cardiovascular disease: A scientific statement from the American Heart Association Council on Epidemiology and Prevention, the Stroke Council, and the Functional Genomics and Translational Biology Interdisciplinary Working Group. Circulation. Retrieved March 21, 2011 from http://circ.ahajournals.org/cgi/content/full/115/22/2878.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2011). KIF6 genotyping for predicting cardiovascular risk and/or effectiveness of statin therapy (2.04.67). Retrieved March 21, 2011 from BlueWeb. (19 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Health Technology Trends. (2007, December) Genomics in cardiac care: How far away are we from the clinical setting? Retrieved March 21, 2011 from ECRI Institute.
Iakoubova, O., Sabatine, M. S., Rowland, C. M., Tong, C. H., Catanese, J. J., Ranade, K., et al. (2008). Polymorphism in KIF6 gene and benefit from statins after acute coronary syndromes: Results from the PROVE IT-TIMI 22 study. Journal of the American College of Cardiology, 2008 (51), 449-455. (Level 2 Evidence - Industry sponsored)
Iakoubova, O., Shepherd, J., & Sacks, F. (2008). Association of the 719Arg variant of KIF6 with both increased risk of coronary events and with greater response to statin therapy. Journal of the American College of Cardiology, 2008 (51), 2195. (Level 2 Evidence - Industry sponsored)
Topol, E. J. & Damani, S. B. (2010). The KIF6 collapse. Journal of the American College of Cardiology, 2010 (56), 1564-1566. (Level 5 Evidence)
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. (October 2010). Cardiovascular Disease Screening. Retrieved February 2, 12011 from http://www.cms.gov/CardiovasDiseaseScreening/.
ORIGINAL EFFECTIVE DATE: 10/8/2011
MOST RECENT REVIEW DATE: 10/8/2011
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