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.
The National Comprehensive Cancer Network recommends using RFA and cryoablation for residual or recurrent high grade or low grade dysplasia, further recommending that long-term palliation of dysphagia can be treated with endoscopic tumor ablation by Nd: YAG laser, PDT or cryoablation.
Radiofrequency ablation (RFA) for treatment of Barrett’s esophagus with biopsy confirmed dysplasia is considered medically necessary.
Cryoablation for the treatment of Barrett’s esophagus (including associated dysphagia), with biopsy confirmed dysplasia is considered medically necessary.
Photodynamic therapy for the treatment of Barrett’s esophagus is considered medically necessary if the medical appropriateness criteria are met (see Medical Appropriateness below.)
Radiofrequency ablation (RFA), cryoablation and/or photodynamic therapy for treatment of Barrett’s esophagus in the absence of dysplasia is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
One or more courses of photodynamic therapy is considered medically appropriate if ANY ONE of the following are met:
Biopsy proven high grade dysplasia
Palliation of dysphagia
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.
For patients with non-dysplastic Barrett’s esophagus, it cannot be concluded that the benefit of RFA outweighs the risk, and therefore RFA is considered investigational. Data for the efficacy of cryoablation of BE with or without dysplasia are limited. The studies consist of small numbers of patients with short-term follow-up, and therefore, cryoablation of Barrett’s esophagus is considered investigational.
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. (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.
American Gastroenterological Association. (March 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. (March 2011) American Gastroenterological Association technical review on the management of Barrett's esophagus. Retrieved November 6, 2017 from http://www.gastrojournal.org.
Berry, M., Zeyer-Brunner, J., Castleberry, A., Martin, J., Gloor, B., Pietrobon, R., et al. (2013, June) 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. Medical Policy Reference Manual. (11:2016). Endoscopic radiofrequency ablation or cryoablation for Barrett’s esophagus (2.01.80). Retrieved November 6, 2017 from BlueWeb. 48 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2017). Oncologic applications of photodynamic therapy, including Barrett's esophagus (8.01.06). Retrieved November 8, 2017 from BlueWeb. (84 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., and Rice, T. (2009, October) 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), 635-44. Abstract retrieved November 6, 2017 from PubMed database.
Gosain, S., Mercer, K., Twaddell, W., Uradomo, L., and Greenwald, B. (2013, August) Liquid nitrogen spray cryotherapy in Barrett's esophagus with high-grade dysplasia: long-term results. Gastrointestinal Endoscopy, 78(2), 260-5. Abstract retrieved November 6, 2017 from PubMed database.
National Comprehensive Cancer Network. (2017, October). NCCN clinical practice guidelines in oncology (NCCN Guidelines®) Esophageal and esophagogastric junction cancers. Version 4.2017. Retrieved November 6, 2017 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, N., et al. (March 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)
Shaheen, N., Greenwald, B., Peery, A., Dumot, J., Nishioka, N., Wolfsen, H., et al. (2010, April) Safety and efficacy of endoscopic spray cryotherapy for Barrett’s esophagus with high-grade dysplasia. Gastrointestinal Endoscopy, 71(4), 680-685. (Level 3 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: 3/1/2018
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.