Prophylactic Oophorectomy
DESCRIPTION
Prophylactic oophorectomy is the removal of the ovaries in the absence of malignant disease. This surgery is being used in women who have a higher risk for ovarian cancer, due to either family history or presence of a BRCA1 or BRCA2 mutation. Ovarian epithelial carcinoma is one of the most common gynecological malignancies and is the leading cause of death due to gynecological malignancy. The average age at diagnosis is 63. In the general population, the lifetime risk of developing ovarian cancer is 1.5%. However, due to the inadequate screening techniques for ovarian cancer, which include pelvic examination, transvaginal ultrasound, and serum CA-125 testing, survival rates for ovarian cancer are very low. The majority of cases remain undiagnosed until the disease is well advanced. The cause of ovarian cancer is unknown, but some suggest that risk increases with older age, nulliparity, and a family history of the disease.
Two major familial ovarian cancer syndromes are known to exist:
Hereditary ovarian cancer syndrome - refers to three hereditary patterns found within two or more generations of relatives.
Site-specific ovarian cancer:
Usually results in disease occurring ten years earlier. The relative risk of a woman with a single first-degree relative with ovarian cancer is estimated as being 3.6 times that of the general population.
Breast-ovarian cancers:
Occurs in families who have an unusual clustering of breast and ovarian cancers. These can occur as dual primary cancers in the same individual. These individuals usually develop breast cancer in their thirties or forties, followed by epithelial ovarian cancer five to ten years later.
Hereditary nonpolyposis colorectal cancer (HNPCC):
An autosomal dominantly inherited syndrome associated with ovarian and endometrial cancers, and is also known as Lynch Syndrome II.
A strong family history of ovarian cancer:
Includes women whose families have isolated cases of ovarian cancer, often with only one affected first- or second-degree relative, without evidence of a hereditary pattern. Women with two or more first-degree relatives with ovarian cancer have the highest risk, at approximately 5.5%. Women with one first- or second-degree relative with ovarian cancer have a slightly lower risk, at approximately 3.7%.
Genetic linkage to breast-ovarian cancer syndrome or site-specific ovarian cancer has been found in the BRCA1 gene located on chromosome 17q21 and the BRCA2 gene located on chromosome 13q. Depending on the population studied the lifetime risk of early-onset ovarian cancer in carriers of mutations of the BRCA1 gene ranges from 5% to 85%. The presence of BRCA2 also indicates an increased risk of breast and ovarian cancer at an estimated 10% by age 70.
POLICY
Prophylactic oophorectomy for women with a high risk of hereditary ovarian cancer is considered medically necessary if medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pre- and post-counseling as an adjunct to the prophylactic oophorectomy procedure is considered medically necessary if medical appropriateness criteria are met. (See Medical Appropriateness below.)
Prophylactic oophorectomy for women with a low or average risk of ovarian cancer whose BRCA gene carrier status is unknown or negative is considered investigational.
MEDICAL APPROPRIATENESS
A prophylactic oophorectomy, for an individual with a high risk of hereditary ovarian cancer, is considered medically appropriate when ALL of the following criteria are met:
ANY ONE of the following high risk criteria:
Two or more first-degree relatives with ovarian or breast cancer
One first-degree relative and one second-degree relative with ovarian or breast cancer before the age of 50 years
One first-degree relative and two or more second-degree or third-degree relatives with ovarian or breast cancer
Presence of a BRCA1 or BRCA2 mutation
The individual must undergo pre- and post-counseling as an adjunct to the prophylactic oophorectomy procedure regarding cancer risks with a health professional, other than the operating surgeon, who is skilled in assessing cancer risk. Cancer risk should be assessed by performing a complete family history to estimate the risk of cancer and discussion of the various treatment options
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
Some families have pedigrees that are very small, and therefore have only one first-degree relative with breast or ovarian cancer that is diagnosed before the age of 50. These individuals should also be considered for a prophylactic oophorectomy since they would not have more than one family member that could be diagnosed.
A small percentage of women may develop primary peritoneal carcinomatosis, a tumor that is histologically similar to ovarian cancer, after prophylactic oophorectomy. Women should be counseled about this possibility prior to the prophylactic oophorectomy.
SOURCES
American College of Obstetricians and Gynecologists. (2008, January). ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 89. Elective and risk - reducing oophorectomy. Retrieved September 15, 2008 from http://www.acog.org/.
Dann, R. B., Kelley, J. L., & Zorn, K. K. (2007). Strategies for ovarian cancer prevention. Obstetrics and Gynecology Clinics of North America, 34 (4) 667-686.
Madalinska, J. B., Hollenstein, J., Bleiker, E., van Beurden, M., Valdimarsdottir, H. B., Massuger, L. F., et al. (2005). Quality of life effects of prophylactic salpingo-oophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. Journal of Clinical Oncology, 23 (28), 6817-6819. (Level 4 Evidence - Independent study)
National Guideline Clearinghouse. (2008, January). Elective and risk-reducing salpingo-oophorectomy. Retrieved September 9, 2008 from http://www.guidelines.gov.
National Cancer Institute. (2010, July). Ovarian cancer screening (PDQ®). Retrieved July 11, 2011 from http://www.cancer.gov/cancertopics/pdq/screening/ovarian/healthprofessional/allpages.
National Cancer Institute. (2010, July). Ovarian cancer prevention (PDQ®). Retrieved July 11, 2011 from http://www.cancer.gov/cancertopics/pdq/prevention/ovarian/healthprofessional/allpages.
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.
Palomba, S., Zupi, E., Russo, T., Falbo, A., Del Negro, S., Manguso, F., et al. (2007). Comparison of two fertility-sparing approaches for bilateral borderline ovarian tumours: A randomized controlled study. Human Reproduction, 22 (2), 578-585. (Level 2 Evidence - Independent study)
Parker, W. H., Broder, M. S., Liu, Z., Shoupe, D., Farquhar, C., & Berek, J. S. (2005). Ovarian conservation at the time of hysterectomy for benign disease. Obstetrics & Gynecology, 106 (2), 219-226. (Level 4 Evidence - Independent study)
Pavelka, J. C., Li, A. J., & Karlan, B. Y. (2007). Hereditary ovarian cancer - assessing risk and prevention strategies. Obstetrics and Gynecology Clinics of North America, 34 (4), 651-665.
Rocca, W. A., Grossardt, B. R., de Andrade, M., Malkasian, G. D., & Melton L. J. (2006). Survival patterns after oophorectomy in premenopausal women: A population-based cohort study. Lancet Oncology, 7 (10), 821-828. (Level 2 Evidence - Independent study)
Schwartz, M. D., Kaufman, E., Peshkin, B. N., Isaacs, C., Hughes, C., DeMarco, T., et al. (2003). Bilateral prophylactic oophorectomy and ovarian cancer screening following BRCA1/BRCA2 mutation testing. Journal of Clinical Oncology, 21 (21), 4034-4041. (Level 2 Evidence - Independent study)
ORIGINAL EFFECTIVE DATE: 12/1/2002
MOST RECENT REVIEW DATE: 8/11/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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