Prophylactic Mastectomy
DESCRIPTION
A prophylactic mastectomy is the removal of the breast in the absence of malignant disease. This surgery is being used in women who have a high risk for breast cancer, due to either family history, presence of a BRCA1 or BRCA2 mutation, having received radiation therapy to the chest, or the presence of lesions associated with an increased cancer risk. These lesions are either atypical hyperplasia or lobular carcinoma in situ (LCIS).
Two types of prophylactic mastectomy can be performed:
Total (also referred to as simple) mastectomy, in which the intent is to remove the entire breast and nipple areolar complex, and
Subcutaneous mastectomy, where the nipple areolar complex is left intact for a more natural appearance.
The total mastectomy is generally preferred over a subcutaneous mastectomy because there is less residual tissue.
POLICY
Prophylactic mastectomy, either total or subcutaneous, for women with a high risk of hereditary breast cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Prophylactic mastectomy, either total or subcutaneous, for biopsies showing lobular carcinoma in situ (LCIS) or when there is increased risk for breast cancer related to having a previous carcinoma in one breast is considered medically necessary.
Prophylactic mastectomy for atypical hyperplasia when BRCA gene carrier status is unknown or negative is considered not medically necessary.
Prophylactic mastectomy for non-proliferative fibrocystic changes (benign breast changes or fibrocystic changes) or proliferative diseases without atypica is considered not medically necessary.
See also: Mammography Screening
MEDICAL APPROPRIATENESS
A prophylactic mastectomy, either total or subcutaneous, is considered medically appropriate for an individual with a high risk of hereditary breast cancer with ALL of the following:
ANY ONE of the following high-risk criteria:
Two or more first-degree relatives with breast cancer or ovarian cancer
One first-degree relative and two or more second-degree or third-degree relatives with breast cancer
One first-degree relative with breast cancer before the age of 45 years and one other relative with breast cancer
One first-degree relative with breast cancer and one or more relatives with ovarian cancer
Two second-degree or third-degree relatives with breast cancer and one or more with ovarian cancer
One second-degree or third-degree relative with breast cancer and two or more with ovarian cancer
Three or more second-degree or third-degree relatives with breast cancer
One first-degree relative with bilateral breast cancer
Presence of a BRCA1 or BRCA2 mutation in the individual consistent with a BRCA1 or BRCA2 mutation in a family member with breast or ovarian cancer
Presence of a p53 or PTEN (phosphatase and tensin homolog) mutation
The individual must undergo pre- and post-counseling as an adjunct to the prophylactic mastectomy procedure regarding cancer risks with a health professional skilled in assessing cancer risk other than the operating surgeon. Cancer risk should be assessed by performing a complete family history, use of the Gail or Claus model (Note: See Additional Information below) to estimate the risk of cancer, and discussion of the various treatment options, including increased surveillance or chemoprevention with tamoxifen.
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 appropriateness of a prophylactic mastectomy is a complicated risk-benefit analysis that requires estimates of an individual's risks of breast cancer, typically based on the individual's family history of breast cancer and other factors. Two models frequently used are the Claus model and the Gail model:
The Gail model uses the following five risk factors: age at evaluation, age at menarche, age at first live birth, number of breast biopsies, and number of first-degree relatives with breast cancer.
The Claus model can be used to predict the cumulative probability of disease in individuals based on a particular family history of breast cancer and known age of disease onset.
The family history of breast cancer is considered in first and second-degree relatives with the Claus model, but only first-degree relatives with the Gail model.
Mammography, clinical breast exam, and breast self-examination remain the most effective screening tools for the prevention of breast cancer. Individuals need to continue to get mammograms even after a prophylactic mastectomy because there is still the possibility of developing breast cancer.
Prophylactic mastectomy, for the conditions listed as investigational reflects the lack of evidence that prophylactic mastectomy would reduce breast cancer risk and/or improve life expectancy for these individuals.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2008). Prophylactic mastectomy (7.01.09). Retrieved January 13, 2011 from BlueWeb. (5 articles and/or guidelines reviewed)
De Leeuw, J. R., van Vliet, M. J., & Ausems, M. G. (2008). Predictors of choosing life-long screening or prophylactic surgery in women at high and moderate risk for breast and ovarian cancer. Familial Cancer, 7 (4), 347-359. (Level 4 Evidence - Independent study)
Decaril, A., Calza, S., Masala, G., Specchia, C., Palli, D., & Gail, M. H. (2006). Gail model for prediction of absolute risk of invasive breast cancer: Independent evaluation in the Florence-European Prospective Investigation into Cancer and Nutrition cohort. Journal of the National Cancer Institute, 98 (23), 1686-1693. (Level 3 Evidence - Independent study)
Geiger, A. M., Yu, O., Herrinton, L. J., Barlow, W. E., Harris, E. L., Rolnick, S., et al. (2005). A population-based study of bilateral prophylactic mastectomy efficacy in women at elevated risk for breast cancer in community practices. Archives of Internal Medicine, 165 (5), 516-520. (Level 2 Evidence - Independent study)
Lester, J. (2007). Breast cancer in 2007: Incidence, risk assessment, and risk reduction strategies. Clinical Journal of Oncology Nursing, 11 (5), 619-622.
Lostumbo L., Carbine N., Wallace J., Esso J. Prophylactic mastectomy for the prevention of breast cancer. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD002748.DOI: 10.1002/14651858.CD002748.pub2.
National Comprehensive Cancer Network (NCCN). (20011, January). NCCN clinical practice guidelines in oncology™. Breast cancer risk reduction. (V.1.2011). Retrieved February 14, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf.
National Guidelines Clearinghouse. (2005). Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility: Recommendation statement. Retrieved March 9, 2009 from http://www.guidelines.gov.
Oseni, T., & Jatoi, I. (2008). An overview of the role of prophylactic surgery in the management of individuals with a hereditary cancer predisposition. Surgical Clinics of North America, 88 (4), 739-758.
Palomares, M. R., Machia, J. R., Lehman, C. D., Daling, J. R., & McTiernan, A. (2006). Mammographic density correlation with Gail model breast cancer risk estimates and component risk factors. Cancer Epidemiology, Biomarkers & Prevention, 15 (7), 1324-1330. (Level 1 Evidence - Independent study)
Rebbeck, T. R., Friebel, T., Lynch, H. T., Neuhausen, S. L., van’t Veer, L., Garber, J. E., et al. (2004). Bilateral prophylactic mastectomy reduces breast cancer risk in BRCA1 and BRCA2 mutation carriers: The PROSE Study Group. Journal of Clinical Oncology, 22 (6), 1055-1062. (Level 1 Evidence - Independent study)
Saslow, D., Boetes, C., Burke, W., Harms, S., Leasch, M. O., Lehman, C. D., et al. (2007). American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA: A Cancer Journal for Clinicians, 57 (2), 75-89.
Schover, L. R. (2008). A lesser evil: Prophylactic mastectomy for women at high risk for breast cancer. Journal of Clinical Oncology, 26 (24), 3918-3919.
The Society of Surgical Oncology. (March, 2007). Society of Surgical Oncology: Position statement on prophylactic mastectomy. Retrieved March 9, 2009 from http://www.surgonc.org/default.aspx?id=47&fragment=0&SearchType=AndWords&terms=Prophylactic%20mastectomy.
Tuttle, T. M., Jarosek, S., Habermann, E. B., Arrington, A., Abraham, A., Morris, T. J., et al. (2009). Increasing rates of contralateral prophylactic mastectomy among patients with ductal carcinoma in situ. Journal of Clinical Oncology, 27 (9), 1362-1367. (Level 1 Evidence - Independent study)
Uyei, A., Peterson, S. K., Erlichman, J., Broglio, K., Yekell, S., Schmeler, K., et al. (2006). Association between clinical characteristics and risk-reduction interventions in women who underwent BRCA1 and BRCA2 testing: A single-institution study. Cancer, 107 (12), 2745-2751. (Level 1 Evidence - Independent study)
van Roosmalen M. S., Stalmeier, P. F., Verhoef, L. C., Hoekstra-Weebers, J. E., Oosterwijk, J. C., Hoogerbrugge, N., et al. (2004). Randomized trial of a shared decision-making intervention consisting of trade-offs and individualized treatment information for BRCA1/2 mutation carriers. Journal of Clinical Oncology, 22 (16), 3293-3301. (Level 2 Evidence - Independent study)
Zakaria, S., & Degnim, A. C. (2007). Prophylactic mastectomy. The Surgical Clinics of North America, 87 (2), 317-331.
ORIGINAL EFFECTIVE DATE: 2/1/2001
MOST RECENT REVIEW DATE: 3/9/2011
ID_BT
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