Ablation Treatments for Barrett’s Esophagus
Barrett’s esophagus (BE) is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia. Intestinal metaplasia is a precursor to adenocarcinoma.
These metaplastic changes can be triggered by the inflammation and injury caused by chronic gastroesophageal reflux or chronic esophagitis and is associated with an increased risk of developing adenocarcinoma of the esophagus. Barrett’s esophagus is confirmed by biopsy of the epithelium and microscopic identification of the metaplastic cells, and differentiated into low grade or high grade dysplasia.
Endoscopic resection and mucosal ablation have become the preferred treatment for most patients with Barrett’s esophagus and high grade dysplasia (with radiofrequency ablation traditionally being the first choice). The types of ablation procedures include:
Radiofrequency ablation (e.g., Barrx™ 360 RFA Balloon Catheter or Barrx™ 90 RFA Focal Catheter) uses bipolar electrodes and an ablation catheter or balloon to rapidly deliver radiofrequency energy to the dysplastic tissue. All the identified diseased tissue of the superficial epithelium is ablated or destroyed and removed without damaging the submucosa.
Cryotherapy (e.g., CryoSpray Ablation™ System) uses a low-pressure liquid nitrogen spray through an upper endoscope. Dis-advantages include the uneven application of the cryogen spray.
Photodynamic therapy (PDT) utilizes a photosynthesizing drug (e.g. sodium porfimer) given intravenously that accumulates in cancerous tissues. After a period of time ranging from a few minutes to 48 hours, the treated cancer cells are exposed to a low-energy single wavelength laser light that activates the drug and ablates the tissue.
Radiofrequency ablation (RFA) for the treatment of Barrett’s esophagus with biopsy confirmed dysplasia is considered medically necessary.
Cryoablation for the treatment of Barrett’s esophagus with biopsy confirmed dysplasia is considered medically necessary.
Photodynamic therapy for the treatment of Barrett’s esophagus with biopsy confirmed high-grade dysplasia is considered medically necessary.
Radiofrequency ablation (RFA), cryoablation and/or photodynamic therapy for treatment of Barrett’s esophagus in the absence of dysplasia are considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be 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.
American College of Gastroenterology. (2015). ACG clinical guideline: diagnosis and management of Barrett’s esophagus. Retrieved December 14, 2016 from http://gi.org.
American Gastroenterological Association. (2011). American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Retrieved December 14, 2016 from http://www.gastrojournal.org.
American Gastroenterological Association. (2011). American Gastroenterological Association technical review on the management of Barrett's esophagus. Retrieved November 6, 2017 from http://www.gastrojournal.org.
American Gastroenterological Association. (2016). Diagnosis and management of low-grade dysplasia in Barrett’s esophagus: clinical practice updates expert review from the clinical guidelines committee of the American Gastroenterological Association. Gastroenterology, 2016 Oct 1. (Epub ahead of print). Abstract retrieved December 14, 2016 from PubMed database.
Berry, M., Zeyer-Brunner, J., Castleberry, A., Martin, J., Gloor, B., Pietrobon, R., et al. (2013). Treatment modalities for T1N0 esophageal cancers: a comparative analysis of local therapy vs. surgical resection. Journal of Thoracic Oncology, 8 (6), 796-802. (Level 4 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (11:2017). Endoscopic radiofrequency ablation or cryoablation for Barrett’s esophagus (2.01.80). Retrieved October 12, 2018 from https://www.evidencepositioningsystem.com/ 48 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (7:2018). Oncologic applications of photodynamic therapy, including Barrett's esophagus (8.01.06). Retrieved October 12, 2018 from https://www.evidencepositioningsystem.com/ (82 articles and/or guidelines reviewed)
Chadwick, G., Groene, O., Markar, S., Hoare, J., Cromwell, D., & Hanna, G. (2014). Systematic review comparing radiofrequency ablation and complete endoscopic resection in treating dysplastic Barrett’s esophagus: a critical assessment of histologic outcomes and adverse events. Gastrointestinal Endoscopy, 79 (5), 718-731. Abstract retrieved December 14, 2016 from PubMed database.
Desai, M., Saligram, S., Gupta, N., Vennalaganti, P., Bansal, A., Choudhary, A., et al. (2016). Efficacy and safety outcomes of multimodal endoscopic eradication therapy in Barrett’s esophagus-related neoplasia: a systematic review and pooled-analysis. Gastrointestinal Endoscopy, 2016 Sep 23. (Epub ahead of print). Abstract retrieved December 14, 2016 from PubMed database.
Dumot, J., Vargo, J., Falk, G., Frey, L., Lopez, R., & Rice, T. (2009). An open-label, prospective trial of cryospray ablation for Barrett's esophagus high-grade dysplasia and early esophageal cancer in high-risk patients. Gastrointestinal Endoscopy, 70 (4), 635-644. Abstract retrieved November 6, 2017 from PubMed database.
Gosain, S., Mercer, K., Twaddell, W., Uradomo, L., & Greenwald, B. (2013). Liquid nitrogen spray cryotherapy in Barrett's esophagus with high-grade dysplasia: long-term results. Gastrointestinal Endoscopy, 78 (2), 260-265. Abstract retrieved November 6, 2017 from PubMed database.
National Comprehensive Cancer Network. (2018, May). NCCN clinical practice guidelines in oncology (NCCN Guidelines®)) Esophageal and esophagogastric junction cancers. Version 2.2018. Retrieved October 12, 2018 from the National Comprehensive Cancer Network.
National Institute for Health and Clinical Excellence. (2010). Barrett’s oesophagus: ablative therapy. Retrieved December 14, 2016 from www.nice.org.uk/guideance.
National Institute for Health and Clinical Excellence. (2014). Endoscopic radiofrequency ablation for Barrett’s oesophagus with low-grade dysplasia or no dysplasia. Retrieved December 14, 2016 from www.nice.org.uk/guidance.
Orman, E., Li, N., & Shaheen, N. (2013). Efficacy and durability of radiofrequency ablation for Barrett’s esophagus: systematic review and meta-analysis. Clinical Gastroenterology and Hepatology, 2013, 11, 1245-1255. (Level 2 evidence)
Phoa, K.,van Vilsteren, F., Weusten, B., Bisschops, R., Schoon, E., Ragunath, K., et al. (2014). Radiofrequency Ablation vs Endoscopic Surveillance for Patients with Barrett Esophagus and Low-Grade Dysplasia: A Randomized Clinical Trial. Journal of American Medical Association. 311 (12), 1209-1217. (Level 2 evidence)
U.S. Food and Drug Administration. (2005, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060169 (HALO90). Retrieved June 9, 2011 from http://www.accessdata.fda.gov.
U.S. Food and Drug Administration. (2007, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070893 (CryoSpray™). Retrieved November 6, 2017 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 10/9/2010
MOST RECENT REVIEW DATE: 11/8/2018
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.