Genetic Testing for HER-2
DESCRIPTION
HER2 is a protein receptor for the human epidermal growth factor that can be found on the surface of certain cancer cells. It is produced by a specific gene , HER2/neu, an oncogene. When human epidermal growth factor attaches itself to HER2 receptors on cancer cells, it can stimulate the cells to divide and grow at more aggressive rates and is associated with a faster growing form of cancer. A genetic mutation of HER2/neu, frequently found in cancer cells, can amplify the production of HER-2 proteins. HER2/neu has been found to be elevated in individuals with a number of different epithelial cell cancers, including breast, lung, colorectal, and ovarian cancers. These individuals with an overexpression of HER 2 also have a greater chance of developing distant metastases and are they usually candidates for more intensive treatment. Testing for HER-2 over-expression and amplification is available.
Some tests (e.g., the Oncor Inform® HER-2/neu Gene Detection System and the PathVysion® HER-2 DNA Probe Kit) are based on fluorescence in situ hybridization (FISH) detection of the HER-2/neu gene amplification in small, paraffin-embedded breast cancer specimens. FISH detection uses a DNA probe to target and hybridize with gene sequences on DNA chromosomes. The fluorescent signals present in twenty randomly selected cancer nuclei are counted. The mean number of HER-2/neu signals per nucleus is determined. Generally a positive test is indicated by the presence of greater than 4 signals per nucleus.
Another test (e.g., DAKO Corporation's HercepTest) is an in-vitro immunohistochemical (IHC) assay that detects HER-2/neu gene over-expression by using specific antibodies that recognize, bind to, and stain cell-surface receptors that are produced by HER-2/neu gene. The slides are evaluated by a pathologist during light microscopic examination as strongly positive (3+), weakly positive (2+), or negative (0 - 1+). The results are dependent upon the observed intensity of immunostaining.
The U.S. Food and Drug Administration (FDA) have approved the SPOT-Light HER2 CISH kit, a genetic test for determining whether individuals with breast cancer are candidates for treatment with the drug Herceptin (trastuzumab).
POLICY
HER-2 genetic testing for individuals with breast cancer is considered medically necessary.
HER-2 genetic testing for any other indication is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be 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
Data from clinical studies provide little evidence of the clinical utility of HER-2 genetic testing for any other purpose except breast cancer.
SOURCES
Dendukuri, N., Ihetani, K., McIsaac, M., & Brophy, J. (2007). Testing for HER2-positive breast cancer: A systematic review and cost-effectiveness analysis. Canadian Medical Association Journal, 176 (10), 1429-1434.
National Comprehensive Cancer Network. (2011, February). NCCN clinical practice guidelines in oncology™. Breast cancer - V.2.2011. Retrieved July 18, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
Sauter, G., Lee, J., Bartlett, J., Slamon, D., & Press, M. (2011) Guidelines for human epidermal growth factor receptor 2 testing: Biologic and methodologic considerations. Journal of Clinical Oncology, 27 (8), 1323-1332.
U. S. Food and Drug Administration. (2001, December). Center for Devices and Radiological Health. Summary of safety and effectiveness data. Retrieved July 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P980024S001b.pdf.
U. S. Food and Drug Administration. (2001, December). Center for Devices and Radiological Health. Summary of safety and effectiveness data. Retrieved July 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100027b.pdf.
ORIGINAL EFFECTIVE DATE: 9/1998
MOST RECENT REVIEW DATE: 9/22/2011
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