Urinary bladder cancer, a relatively common form of cancer in the United States, results in significant morbidity and mortality. Bladder cancer (urothelial carcinoma), typically presents as a tumor confined to the superficial mucosa of the bladder. The most frequent symptom of early bladder cancer is hematuria; however, urinary tract symptoms (i.e., urinary frequency, urgency, dysuria) may also occur.
The diagnosis of bladder cancer is generally made by cystoscopy and biopsy. Due to high frequency of recurrence of disease, follow-up cystoscopies along with urine cytology are employed for periodic surveillance to identify recurrence early. While urine cytology is a specific test (from 90-100%), its sensitivity is lower, ranging from 50-60% overall and is considered even lower for low-grade tumors. However, according to the current National Comprehensive Cancer Network (NCCN®) Guidelines for Bladder Cancer “…it remains unclear whether these tests offer additional information that is useful for detection and management of bladder tumors.”
More than 30 urinary biomarkers have been reported for use in bladder cancer diagnosis, a few that are commercially available include the following:
Aura Tek FDP Test™
BTA stat® test
BTA TRAK® test
UroVysion® Bladder Cancer Kit
The use of urinary tumor markers in the diagnosis of, monitoring of, and/or screening for bladder cancer is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relatesonly 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.
The sensitivity and specificity of various urinary tumor markers in the diagnosing and/or monitoring of bladder cancer have been studied. There is little evidence that the results of tumor marker tests have a measurable impact on patient management (e.g., the frequency of cystoscopy) or on health outcomes to date. There is also a lack of evidence that tumor markers for detection of bladder cancer are clinically useful as screening tools in asymptomatic individuals.
American Urological Association. (2016). Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. Retrieved September 27, 2016 from http://www.auanet.org.
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2017). Urinary tumor markers for bladder cancer. (2.04.07). Retrieved August 23, 2017 from BlueWeb. (22 articles and/or guidelines reviewed)
Chou, R., Gore, J. L., Buckley, D., Fu, R., Gustafson, K., Griffin, J. C., et al. (2015). Urinary biomarkers for diagnosis of bladder cancer: a systematic review and meta-analysis. Annals of Internal Medicine, 163 (12), 922-931. Abstract retrieved September 27, 2016 from PubMed database.
First Coast Service Options, Inc. (2015, October). Local Coverage Determination (LCD): Urinary tumor markers for bladder cancer (L33965). Retrieved August 23, 2017 from https://www.cms.gov
Hosseini, J., Golshan, A., Mazloomfard, M., Mehrsai. A., Zargar. M., Ayati. M., et al. (2010). Detection of recurrent bladder cancer NMP22 test or urine cytology? Urology Journal, 9 (1), 367 - 372. (Level 1 evidence - Independent study)
Meo, A., Bartlett, J., Cheng, Y., Pasic, M., and Yousef, G. (2017). Liquid biopsy: a step forward towards precision medicine in urologic malignancies. Molecular Cancer, 16, 80. (Level 2 evidence)
National Comprehensive Cancer Network. (2017, May). NCCN clinical practice guidelines in oncology (NCCN®) Bladder cancer (Version 5.2017). Retrieved August 23, 2017 from http://www.nccn.org .
National Institute of Health and Care Excellence. (2015, February). NICE guideline: bladder cancer: diagnosis and management. Retrieved August 23, 2017 from www.nice.org.uk.
Parker, J. & Spiess, P. (2011). Current and emerging bladder cancer urinary biomarkers. The Scientific World Journal: Urology, 11, 1103-1112. (Level 5 evidence)
Shariat, S., Savage, C., Chromecki, T., Sun, M., Scherr, D., Lee, R., et al. (2011). Assessing the clinical benefit of NMP22 in the surveillance of patients with non–muscle-invasive bladder cancer and negative cytology: a decision-curve analysis. Cancer, 117 (13), 2892-2897. (Level 3 evidence - Independent study)
U. S. Food and Drug Administration. (1998, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database.K971402 (BTA TRAK®). Retrieved September 27, 2016 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2000, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K994356 (Immunocyte®). Retrieved September 27, 2016 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2002, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K021231 (NMP22® BladderCheck® Kit). Retrieved August 31, 2012 from http://www.accessdata.fda.gov.
U.S. Preventive Services Task Force. (2014). Guide to clinical preventative services, 2017, bladder cancer. Retrieved August 23, 2017 from http://www.ahrq.gov.
ORIGINAL EFFECTIVE DATE: 3/14/2013
MOST RECENT REVIEW DATE: 10/26/2017
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