Coverage Policy Manual
Policy #: 2003059
Category: Surgery
Initiated: August 2003
Last Review: June 2018
  Oophorectomy, Prophylactic

Description: Prophylactic oophorectomy is the preventive, surgical removal of ovaries.  The goal of prophylactic oophorectomy is to prevent the development of ovarian cancer in women who are at high risk for developing ovarian cancer.

The reduction of risk of ovarian, fallopian tube, and/or peritoneal cancer following prophylactic surgical removal of the ovaries and fallopian tubes in persons with known BRCA-1 or BRCA-2 genetic polymorphisms has been estimated to be as high as 95%; however, these previous predictions were from historical studies or small case series.  In the largest prospective study reported to date (2006), the risk of ovarian, fallopian tube, and peritoneal cancer was found to be 80% following prophylactic surgery for patients with known BRCA-1 or BRCA-2 genes. Unfortunately, a 4% risk of peritoneal cancer developing after the surgical removal of the ovaries and fallopian tubes was also noted in this study.

Policy/
Coverage:
Prophylactic oophorectomy, for an individual with a high risk of hereditary ovarian cancer, is considered medically appropriate only when one or more of the following high risk criteria are met:
    • Patients with known BRCA1 or BRCA2 positivity;
    • Patients who have two or more first degree relatives (mother, sister, daughter) who share one half of their genes and have been diagnosed with ovarian carcinoma;
    • Patients who have one first degree and one second degree relative (grandmother or aunt), one of whom has been diagnosed with ovarian cancer and the other has been diagnosed with either ovarian, breast, endometrial, or colon cancer; or
    • Patients who have had one first degree relative who has been diagnosed with ovarian cancer and have no other first degree or second degree female relatives

Rationale:
2010 Update
This policy was initially developed in 2003.  A literature search conducted through September 2010 did not identify any studies that would prompt a change in the coverage statement. One study was identified that supports the existing coverage.
 
Domchek and colleagues reported on a prospective, multicenter cohort study assessing the relationship of risk-reducing mastectomy or salpingo-oophorectomy with cancer outcomes in 2482 women with BRCA1 or BRCA2 mutations (Domchek, 2010).
 
Subjects who were identified as BRCA1/2 mutation carriers in the Prevention and Observation of Surgical Endpoints (PROSE) consortium were considered for inclusion into the study.  Subjects were offered either risk-reducing mastectomy or surveillance or risk-reducing salpingo-oophorectomy or surveillance. Women who declined risk-reducing mastectomy were followed with increased surveillance consisting of annual mammography and magnetic resonance imaging.  Women who underwent mastectomy were followed from the time of their surgery.  The primary endpoint was breast cancer.  If no breast cancer occurred, subjects were followed for ovarian cancer, diagnosis or death.
 
Subjects who did not have risk-reducing salpingo-oophorectomy were followed with transvaginal ultrasound every 6 to 12 months and CA125 blood testing. Subjects who underwent risk-reducing salpingo-oophorectomy were followed from the time of their surgery.  The primary outcomes were ovarian cancer diagnosis, breast cancer diagnosis, second diagnosis of primary breast cancer, and mortality. Subjects were followed until 2009 with an average follow-up of 3.65 years.
 
The authors reported that “risk-reducing mastectomy was associated with a decreased risk of breast cancer in BRCA1/2 mutation carriers.  No breast cancer events were seen in women who underwent risk-reducing mastectomy during 3 years of prospective follow-up.  In contrast, 7% of women without risk-reducing mastectomy over a similar follow-up period were diagnosed with breast cancer”. “In addition, risk-reducing salpingo-oophorectomy is associated with a significant decrease in ovarian cancer risk in both BRCA1 and BRCA2 mutation carriers, and in those with and without a prior diagnosis of breast cancer”.  Risk-reducing salpingo-oophorectomy was also associated with a reduction in all-cause mortality and a decreased risk of breast cancer in both BRCA1 and BRCA2 mutation carriers.
 
2012 Update
A search of the MEDLINE database was conducted through 2012.  The literature search did not reveal any new information that would prompt a change in the coverage statement. Two new guidelines were identified that support the current coverage statement.
 
Guidelines and Recommendations
 
Society of Gynecologic Oncologists Clinical Practice Committee
Berek and colleagues published recommendations based on risk of ovarian cancer for the Society of Gynecologic Oncologists Clinical Practice Committee.  The authors recommend that women with a high risk of ovarian cancer (i.e., personal history of BRCA1/2 mutation, family history of ovarian  or breast cancer) should undergo prophylactic bilateral salpingo-oophorectomy after child bearing is complete.
 
National Comprehensive Cancer Network® (NCCN)
The NCCN guidelines panel recommends risk reduction salpingo-oophorectomy for women with a known BRCA1/2 mutation. The ideal age to perform the procedure is between the ages of 35 and 40 or upon completion of childbearing (NCCN, V.1.2012).
 
2013 Update
A literature search was conducted through May 2013. There was no new information identified that would prompt a change in the coverage statement.
 
2014 Update
A literature search conducted using the MEDLINE database through May 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
The detection of premalignant cells in the epithelium of the fallopian tube has resulted in revolutionary theories regarding the origin of epithelial ovarian cancer (EOC) (Pölcher, 2015). Serous tubal intra-epithelial carcinomas (STIC) have been detected in patients with BRCA 1 or 2 mutations and are considered as the most likely precursors of the high-grade serous ovarian cancer (HGSOC), which is the most common histological subtype in patients with EOC. A bilateral salpingo-oophorectomy is associated with a significant reduction in risk of developing EOC. According to various national guidelines, prophylactic bilateral salpingo-oophorectomy should be performed in the age group 40-45 years. As in patients with BRCA mutations, the prophylactic removal of the fallopian tubes is also performed in women without an increased genetic risk, for example, in surgical treatments of benign conditions. There is a current debate as to whether prophylactic or so-called opportunistic salpingectomy will influence the overall incidence of EOC in the coming years. Opponents of this theory warn of a higher surgical morbidity and the higher risk of a premature menopause through impaired vascular supply to the ovaries. The value of opportunistic salpingectomies has not yet been clarified since there are currently no systematic risk-benefit evaluations. This review will attempt to give an overview of the current body of evidence regarding the risks and benefits of opportunistic salpingectomies.
 
Despite advances in medicine, ovarian cancer remains the deadliest of the gynecological malignancies. Nezhat and colleagues presented the latest information on the pathophysiology of ovarian cancer and its significance for ovarian cancer screening and prevention (Nezhat, 2015). A new paradigm for ovarian cancer pathogenesis presupposes 2 distinct types of ovarian epithelial carcinoma with distinct molecular profiles: type I and type II carcinomas. Type I tumors include endometrioid, clear-cell carcinoma, and low-grade serous carcinoma and mostly arise via defined sequence either from endometriosis or from borderline serous tumors, mostly presenting in an early stage. More frequent type II carcinomas are usually high-grade serous tumors, and recent evidence suggests that the majority arise from the fimbriated end of the fallopian tube. Subsequently, high-grade serous carcinomas usually present at advanced stages, likely as a consequence of the rapid peritoneal seeding from the open ends of the fallopian tubes. On the other hand, careful clinical evaluation should be performed along with risk stratification and targeted treatment of women with premalignant conditions leading to type I cancers, most notably endometriosis and endometriomas. Although the chance of malignant transformation is low, an understanding of this link offers a possibility of prevention and early intervention. This new evidence explains difficulties in ovarian cancer screening and helps in forming new recommendations for ovarian cancer risk evaluation and prophylactic treatments.
 
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
High-grade serous carcinoma (HGSC) is the most common and aggressive histotype of epithelial ovarian cancer (EOC), and it is the predominant histotype associated with hereditary breast and ovarian cancer syndrome (HBOC) (George, 2016).. Mutations in BRCA1 and BRCA2 are responsible for most of the known causes of HBOC, while mutations in mismatch repair genes and several genes of moderate penetrance are responsible for the remaining known hereditary risk. Women with a history of familial ovarian cancer or with known germline mutations in highly penetrant genes are offered the option of risk-reducing surgery that involves the removal of the ovaries and fallopian tubes (salpingo-oophorectomy). Growing evidence now supports the fallopian tube epithelia as an etiological site for the development of HGSC and consequently, salpingectomy alone is emerging as a prophylactic option. This review discusses the site of origin of EOC, the rationale for risk-reducing salpingectomy in the high-risk population, and opportunities for salpingectomy in the low-risk population.   
 
2017 Update
A literature search conducted through May 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search conducted through May 2018 did not reveal any new information that would prompt a change in the coverage statement.

CPT/HCPCS:
58720Salpingo-oophorectomy, complete or partial, unilateral or bilateral (separate procedure)
58940Oophorectomy, partial or total, unilateral or bilateral;

References: Am College of Obstetricians and Gynecologists (ACOG) Prophylactic oophorectomy. http://medem.com, 1999; accessed 8/21/03.

Berek JS, Chalas E, Edelson M, et al.(2010) Society of Gynecologic Oncologists Clinical Practice Committee. Prophylactic and risk-reducing bilateral salpingo-oophorectomy: Recommendations based on risk of ovarian cancer. Obstet Gynecol. 2010;116(3):733-743.

Domchek SM, Friebel TM, Neuhausen Sl, et al.(2006) Mortality after bilateral salpingo-oophorectomy in BRCA1 and BRCA2 mutation carriers. Lancet Onco. 2006;7(3):223-229.

Domchek SM, Friebel TM, Singer CF, et al.(2010) Association of risk-reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality. JAMA. 2010;304(9):967-975.

Eisen A, Rebbeck TR, et al.(2000) Prophylactic surgery in women with a hereditary predisposition to breast and ovarian cancer. J Clin Oncol 2000; 18:1980-95.

Eisen A, Weber B.(2001) Prophylactic mastectomy for women with BRCA1 and BRCA2 mutations - Facts and controversy (editorial). NEJM 2001; 345:207-8.

Esserman L, Kaklamani V.(2010) Lessons learned from genetic testing. JAMA. 2010;304(9):1011-1012.

Finch A, Beiner M, Lubinski J for the Hereditary Ovarian Cancer Clinical Study Group.(2006) Salpingo-oophorectomy and the risk of ovarian, fallopian tube, and peritoneal cancers in women with a BRCA1 or BRCA2 mutation. JAMA 2006; 296:185-92.

George SH, Garcia R, Slomovitz BM(2016) Fallopian Tube as the Site of Origin and Opportunities for Prevention. Front Oncol. 2016 May 2;6:108

Guttmacher AE, Collins FS.(2003) Breast and ovarian cancer. NEJM 2003; 348:2339-47.

Haber D.(2002) Prophylactic oophorectomy to reduce the risk of ovarian and breast cancer in carriers of BRCA mutations (editorial). NEJM 2002; 346:1660-1661.

Hartge P.(2003) Genes, hormones, and pathways to breast cancer (editorial). NEJM 2003; 348:2352-4.

Kauff ND, Satagopan JM, Robson ME, et al.(2002) Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. NEJM 2002; 346:1609-15.

Leeper K, Garcia R, et al.(2002) Pathologic findings in prophylactic oophorectomy specimens in high-risk women. Gynecol Oncol 2002; 87:52-6.

National Comprehensive Cancer Network. NCCN Guidelines Version 1.2012. Hereditary Breast and/or Ovarian Cancer Syndrome. Accessed at www.nccn.org. Last accessed June 29th, 2012.

Nezhat FR, Apostol R, Nezhat C, et al.(2015) New insights in the pathophysiology of ovarian cancer and implications for screening and prevention. 2015 Update. Am J Obstet Gynecol. 2015 Mar 25. pii: S0002-9378(15)00325-7.

Pölcher M, Hauptmann S, Fotopoulou C, et al.(2015) Opportunistic salpingectomies for the prevention of a high-grade serous carcinoma: a statement by the Kommission Ovar of the AGO. Arch Gynecol Obstet. 2015 Jul;292(1):231-4.

Rebbeck TR, Lynch HT, Neuhausen SL, et al.(2002) Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. NEJM 2002; 346:1616-22.

Swanson CL, Bakkum-Gamez JN.(2016) Options in Prophylactic Surgery to Prevent Ovarian Cancer in High-Risk Women: How New Hypotheses of Fallopian Tube Origin Influence Recommendations. Curr Treat Options Oncol. 2016 May;17(5):20.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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