DESCRIPTION
A genetic predisposition to cutaneous malignant melanoma is suspected in 3 different clinical situations. The clinical situations include: 1) melanoma diagnosed in multiple family members; 2) multiple primary melanomas are identified in a single patient; and 3) when there is an early age of onset.
Three main genes involved in cutaneous malignant melanoma susceptibility have now been identified. CDKN2A, located on chromosome 9p21 encodes proteins that act as tumor suppressors. Mutations at this site can alter the tumor suppressor function. The second gene, CDK4, is an oncogene located on chromosome 12q13, and has been identified in about 6 families worldwide. A third gene, not fully characterized, maps to chromosome 1p22.
There is an investigative interest in genetic testing for mutations associated with susceptibility to cutaneous malignant melanoma. However, it is not known if this technology leads to improved diagnosis, treatment or health care outcomes. Currently, clinical evaluation remains the gold standard for determining melanoma risk.
An example of a commercially available genetic test of the CDKN2A gene is Melaris®.
POLICY
Genetic testing for mutations associated with cutaneous malignant melanoma including, but not limited to, the following conditions is considered investigational:
Melanoma diagnosed in multiple family members
Multiple primary melanomas identified in a single individual
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ADDITIONAL INFORMATION
Well-designed studies in peer-reviewed journals, which evaluate genetic testing for mutations associated with susceptibility to cutaneous malignant melanoma, are lacking. It is not known if this technology leads to improved diagnosis, treatment or health care outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2011).Genetic testing for familial cutaneous malignant melanoma (2.04.44). Retrieved November 17, 2011 from BlueWeb. (17 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011 November). Cytogenetic testing (NCD 190.3, p. 2-91). Ingenix.
National Cancer Institute. (2010). Genetics of Skin Cancer (PDQ®) Health professional Version. Retrieved March 23, 2010 from: http://www.cancer.gov/cancertopics/pdq/genetics/skin/healthprofessional/allpages/print.
National Guideline Clearinghouse. National Center for Primary Care. (2008 January). Identification and management of high-risk individuals. In: clinical practice guidelines for the management of melanoma in Australia and New Zealand. Retrieved November 17, 2011 from: http://www.guideline.gov.
Puig, S., Malvehy, J., Badenas, C., Ruiz, A., Jimenez, D., Cuellar, F., et al. (2005). Role of the CDKN2A locus in patients with multiple primary melanomas. Journal of Clinical Oncology, 23 (13), 3043 - 3051. (Level 4 Evidence)
Yang, X., Pfeiffer, R., Wheeler, W., Yeager, M., Chanock, S., Tucker, M., et al. (2009). Identification of modifier genes for cutaneous malignant melanoma in melanoma-prone families with and without CDKN2A mutations. International Journal of Cancer, 125 (12), 2912 - 2917. (Level 4 Evidence - Independent)
ORIGINAL EFFECTIVE DATE: 9/10/2006
MOST RECENT REVIEW DATE: 1/12/2012
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