BlueCross BlueShield of Tennessee Medical Policy Manual

Proteomics-based Testing for the Evaluation of Ovarian (Adnexal) Masses

DESCRIPTION

Ovarian cancer is the second most common type of female reproductive cancer but the leading cause of death from gynecological cancer with a 5 year survival rate below 30%. Adult women presenting with an adnexal mass have an estimated 68% likelihood of having a benign lesion, 6% have borderline tumors, 22% invasive lesions, and 3% metastatic disease. The need for proper triage and specialty care is warranted to improve survival and health outcomes. According to ACOG, “It has been well-established that women with ovarian cancer whose care is managed by a physician who has advanced training and expertise in the treatment of women with gynecologic cancer, such as a gynecologic oncologist, have improved overall survival rates as compared with those treated without such collaboration.”

A variety of proteomic biomarkers have been studied in association with ovarian cancer. Of particular interest are tests that develop a risk score based on the results of multiple analytes. They have been investigated for use in women with adnexal masses of unknown origin, based on routine clinical and radiological evaluations. The scores can be used to estimate the probability of an underlying malignant process and may be useful in determining the pre-operative plan of care.

Several of these tests (e.g. Overa™, OVA1™ and ROMA™) have been designated as Class II devices by the FDA. They are quantitative serum tests that employ specific algorithms to ascribe the risk score.

POLICY

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IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

The 2009 submission of the OVA1™ to the FDA carried the precautionary statement that it is not intended to be used as a screening test or to determine whether a patient should proceed to surgery.

The evidence for use of proteomics-based testing (OVA1 test or ROMA test) is insufficient to determine the effects of the technology on health outcomes.

SOURCES 

American College of Obstetricians and Gynecologists. (2016). Evaluation and management of adnexal masses.  Practice Bulletin 174. Retrieved August 7, 2017 from The American College of Obstetricians and Gynecologists.

BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2016). Multimarker serum testing related to ovarian cancer (2.04.62). Retrieved August 7, 2017 from BlueWeb. (27 articles and/or guidelines reviewed)

Bristow, R. E., Smith, A., Zhang, Z., Chan, D. W., Crutcher, G., & Fung, E. T. (2013). Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecologic Oncology, 128, 252-259. (Level 2 evidence)

Coleman, R. L., Herzog, T. J., Chan, D. W., Munroe, D. G., Pappas, T. C., Smith, A., et al. (2016). Validation of a second-generation multivariate index assay for malignancy risk of adnexal masses. American Journal of Obstetrics & Gynecology, 215 (1), 82.e1-82.e11. Abstract retrieved September 30, 2016 from PubMed database.

Goodrich, S. T., Bristow, R. E., Santoso, J. T., Miller, R. W., Smith, A., Zhang, Z., et al. (2014). The effect of ovarian imaging on the clinical interpretation of a multivariate index assay. American Journal of Obstetrics & Gynecology, 2014, 210. (Level 2 evidence)

Grenache, D., Heichman, K., Werner, T., & Vucetic, Z. (2015). Clinical performance of two multi-marker blood tests for predicting malignancy in women with an adnexal mass. Clinica Chimica Acta, 438, 358-363. Abstract retrieved August 7, 2017 from PubMed database.

Longoria, T. C., Ueland, F. R., Zhang, Z., Chan, D. W., Smith A., Fung, E. T. Clinical performance of a multivariate index assay for detecting early-stage ovarian cancer. American Journal of Obstetrics & Gynecology, 2013, 209, 1e1-1e9.

National Comprehensive Cancer Network. (2017). NCCN clinical practice guidelines in oncology (NCCN guideline®). Ovarian cancer including fallopian tube cancer and primary peritoneal cancer, V.2.2017. Retrieved August 7, 2017 from the National Comprehensive Cancer Network.

National Institute of Health and Clinical Excellence. (2011). Ovarian cancer. Retrieved January 2, 2013 from http://www.nice.org.uk/nicemedia/live/13464/54268/54268.pdf.

Technology Evaluation Center. (2013, April). Multianalyte testing for the evaluation of adnexal masses. (Volume 27, No. 8). Retrieved June 9, 2014 from http://www.bcbs.com/blueresources/tec/vols/27/27_08.pdf.  (29 articles and/or guidelines reviewed)

U.S. Food and Drug Administration. (2009, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081754. Retrieved September 25, 2012 from http://www.accessdata.fda.gov/cdrh_docs/reviews/K081754.pdf.

U.S. Food and Drug Administration. (2011, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K103358. Retrieved September 25, 2012 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/K103358.pdf.

U.S. Food and Drug Administration. (2016, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K150588. Retrieved August 7, 2017 from http://www.accessdata.fda.gov/cdrh_docs/reviews/K150588.pdf.

United States Preventive Services Task Force. (2012). Screening for ovarian cancer. Retrieved January 2, 2013 from http://www.uspreventiveservicestaskforce.org/uspstf12/ovarian/ovarcancerrs.htm.

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, December; last update search December 2016). Architect HE4 assay for ovarian cancer detection. Retrieved August 7, 2017 from wwwHayesinc.com/subscribers (48 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  5/14/2011

MOST RECENT REVIEW DATE:  9/14/2017

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