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 and is 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.

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

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

The evidence for use of proteomics-based testing (Overa®, 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. Evidence Positioning System. (1:2019). Multimarker serum testing related to ovarian cancer (2.04.62). Retrieved July 5, 2019 from https://www.evidencepositioningsystem.com/. (30 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)

CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2019, January). MolDX: Molecular diagnostic tests (MDT). (LCD ID L35025). Retrieved July 5, 2019 from https://www.cms.gov.

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.

Dayyani, F., Uhlig, S., Colson, B., Simon, K., Rolny, V., Morgensterm, D., et al. (2016). Diagnostic performance of risk of ovarian malignancy algorithm against CA 125 and HE4 in connection with ovarian cancer: a meta-analysis. International Journal of Gynecologic Cancer, 26 (9), 1586-1593. Abstract retrieved August 7, 2017 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, 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, 209, 1e1-1e9. (Level 3 evidence)

National Comprehensive Cancer Network. (2019, March). NCCN clinical practice guidelines in oncology (NCCN guideline®). Ovarian cancer including fallopian tube cancer and primary peritoneal cancer, V.1.2019. Retrieved July 5, 2019 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. 

Simmons, A., Clarke, C., Badgwell, D., Lu, Z., Sokoll, L., Lu, K., et al. (2016). Validation of a biomarker panel and longitudinal biomarker performance for early detection of cancer. International Journal of Gynecologic Cancer, 26 (6), 1070-1077. (Level 4 evidence)

U.S. Food and Drug Administration. (2009, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081754 (Ova1®). Retrieved September 25, 2012 from http://www.accessdata.fda.gov. 

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

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

ORIGINAL EFFECTIVE DATE:  5/14/2011

MOST RECENT REVIEW DATE:  8/8/2019         

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