BlueCross BlueShield of Tennessee Medical Policy Manual

Serum Antibodies for the Diagnosis and Management of Inflammatory Bowel Disease: ANCA for Ulcerative Colitis and ASCA for Crohn's Disease

DESCRIPTION

Inflammatory bowel disease (IBD) consists of two major forms; ulcerative colitis (UC) and Crohn's disease (CD).  Both types are characterized by chronic inflammation that can be painful, debilitating and sometimes, life-threatening.  The definitive diagnosis can usually be established by a combination of radiographic, endoscopic, and histologic criteria, although in 10% - 15% of cases, the distinction between UC and CD cannot be made with certainty. Two serum antibodies, anti-neutrophilic cytoplasmic antibodies (ANCA) and anti-Saccharomyces cerevisiae (ASCA) have been associated with IBD. A number of subtypes of these markers have also been identified based on the specific antigen that is targeted.

These serum antibodies are proposed as a method to improve the efficiency and accuracy of diagnosing UC and CD in cases of indeterminate colitis. A second potential use is to classify subtypes of IBD in location of disease (i.e., proximal versus distal bowel involvement) or by disease severity, thereby providing prognostic information.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

No published studies demonstrate the use of the markers addressed in this policy in lieu of a standard work-up for IBD. A number of authors claim that these markers can be used to avoid invasive testing, but no studies demonstrated an actual decrease in the number of invasive tests through use of serum markers. Available evidence does not indicate the use of these tests will likely alter the diagnostic work-up, the final diagnosis made, or the treatment provided for individuals with suspected IBD. The studies available do not determine the impact of these tests on the final health outcome.

SOURCES   

American College of Gastroenterology. (2009). ACG Practice Guidelines. Management of Crohn’s disease in adults. Retrieved March 17, 2016 from http://www.nature.com. 

American College of Gastroenterology. (2010). Ulcerative colitis in adults: american college of gastroenterology, practice parameters committee. Retrieved January 17, 2018 from http://gi.org/guideline.

Elkadri, A., Stempak, J., Walters, T., Lal, S., Griffiths, A., Steinhart, A., & Silverberg, M. (2013). Serum antibodies associated with complex inflammatory bowel disease. Inflammatory Bowel Disease, 19 (7), 1499-1505. Abstract retrieved March 17, 2016 from PubMed database.

Mokhtarifar, A., Ganji, A., Sadrneshin, M., Bahari, A., Esmaeilzadeh, A., Ghafarzadegan, K., & Nikpour, S. (2013). Diagnostic value of ASCA and atypical p-ANCA in differential diagnosis of inflammatory bowel disease. Middle East Journal of Digestive Diseases, 5 (2), 93-97.

Soubières, A., & Poullis, A. (2016). Emerging biomarkers for the diagnosis and monitoring of inflammatory bowel diseases. Inflammatory Bowel Diseases, 22 (8). Abstract retrieved January 26, 2017 from PubMed database.

Sura, S., Ahmed, A., Cheifetz, A., & Moss, A. (2014). Characteristics of inflammatory bowel disease serology in patients with indeterminate colitis. Journal of Clinical Gastroenterology, 48 (4), 351-355. (Level 4 evidence)

U. S. Food and Drug Administration. (2006, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K051927. Retrieved July 26, 2012 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2006, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K030704. Retrieved July 26, 2012 from http://www.accessdata.fda.gov.

Waterman, M., Knight, J., Dinani, A., Xu, W., Stempak, J., Croitoru, K., et al. (2015). Predictors of outcome in ulcerative colitis. Inflammatory Bowel Disease, 21 (9). Abstract retrieved January 26, 2017 from PubMed database.

Winifred S. Hayes, Inc. Medical Technology Directory. (2013, April; last update search March 2017). Serological assays for the diagnosis and management of inflammatory bowel disease: Ulcerative colitis. Retrieved January 17, 2018 from www.Hayesinc.com/subscribers. (64 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2013, March; last update search January 2017). Serological assays for the diagnosis and management of inflammatory bowel disease: Crohn’s Disease. Retrieved January 17, 2018 from www.Hayesinc.com/subscribers. (78 articles and/or guidelines reviewed)

Xiong, Y., Wang, G., Zhou, J., Xia, B., Wang, X., Jiang, B. (2014). Serum antibodies to microbial antigens for Crohn’s disease progression: a meta-analysis. European Journal of Gastroenterology & Hepatology, 26 (7), 733-742. Abstract retrieved March 17, 2016 from PubMed database.

Zhang, Z., Li, C., Zhao, X., Lv, C., He, Q., Lei, S., et al. (2012). Anti-Saccharomyces cerevisiae antibodies associate with phenotypes and higher risk for surgery in Crohn’s disease: a meta-analysis. Digestive Diseases and Sciences, 57 (11), 2944-2954. (Level 1 evidence)

ORIGINAL EFFECTIVE DATE:  7/1/2004

MOST RECENT REVIEW DATE:  2/8/2018

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