Serum Antibodies for the Diagnosis and Management of Inflammatory Bowel Disease: ANCA for Ulcerative Colitis and ASCA for Crohn's Disease
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.
Determination of anti-neutrophil cytoplasmic antibody (ANCA) and anti-Saccharomyces cerevisiae antibody (ASCA) as an aid in the diagnosis and/or management of individuals with inflammatory bowel disease are 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 relates only 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.
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.
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
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.