Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1The patient is a 54-year-old man with long-standing gastroesophageal reflux disease (GERD) whose symptoms are largely controlled on Aciphex 20mg twice a day. His complaint is of breakthrough symptoms when supine at night. The patient has Barretts esophagus (without dysplasia) and has an elevated acid exposure on 24-hour pH testing. He does not have a large hiatal hernia. The patient consulted with his gastroenterologist regarding endoscopic treatments for GERD and an Enteryx procedure was recommended. The Health Plan has denied authorization and coverage for an Enteryx procedure on the basis it is considered investigational for treatment of GERD.The Enteryx procedure involves the injection of ethylene vinyl alcohol copolymer (EVOS) and dimethylsulfoxide (DMSO) into the gastroesophageal junction. Following injection of the EVOS into the lower esophageal sphincter, the DMSO diffuses leaving a spongy mass. The mechanism of action is not known, but it appears to decrease reflux. There is one non-randomized clinical trial, which followed 85 patients over short duration and found symptom reduction in most patients. There was a 34% adverse event rate and one fatal esophageal abscess has been reported in case report form. Though sham controlled trials are underway, at this time the safety data for Enteryx is very limited and the efficacy data is based on a single, open label, short-duration trial. There is nothing on which to base an opinion that Enteryx is likely to be more successful at reducing the patients stated complaint of nocturnal breakthrough than other standard strategies such as a change to esomeprazole or fundoplication surgery. Therefore, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2The patient is a 54-year-old male with a long-standing history of gastroesophageal reflux disease (GERD). It is stated that the patient takes Aciphex and continues to be symptomatic. His EGD showed evidence of Barretts esophagus. A 24-hour pH study showed a DeMeester score of 259. His esophageal manometry revealed hypertensive esophageal contractions. The patient has requested authorization and coverage for an Enteryx procedure. The Health Plan has denied the request indicating that the requested procedure is considered experimental for treatment of GERD.The efficacy of the Enteryx procedure has not been established. The largest study to date, a multicenter trial of over 80 patients, shows 73% of patients who were followed for more than two years had significant improvement in their PPI dependency (Johnson DA, et al.). A recent article in Gastroenterology and Endoscopy News, revealed there is an ongoing open label investigation of the Enteryx procedure with 45-month follow-up data collected from 42 patients. The data showed that 24 months following treatment PPI use was eliminated in 31 patients (74%). Heartburn scores also improved nearly 70% and no clinically significant complications have occurred. Though these results are promising, further studies are needed, which involve longer outcomes and a larger number of patients. At this time, the long-term safety and efficacy of the Enteryx procedure has not been established. Based upon the information set forth above, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3The patient has a long-standing history of gastroesophageal reflux disease (GERD). The patients complaints include heartburn, acid regurgitation, and coughing despite taking Aciphex twice daily. The patient wishes to avoid invasive surgery. He has requested coverage for an Enteryx procedure. The Health Plan has denied the patients request indicating that the Enteryx procedure is considered experimental for treatment of the patients medical condition.  The patient is a 54-year-old male who is symptomatic with GERD. He has failed conventional medical therapy. There are an increasing number of endoscopic measures to improve lower esophageal sphincter function. These include radiofrequency cautery as well as implantation of bulking devices, such as the Enteryx procedure. The alternative is fundoplication, which though highly effective requires general anesthesia and therefore, has an incremental higher risk. Most early phase I trials show these endoscopic procedures to be as safe or safer than fundoplication under anesthesia. Early results confirm Enteryx is efficacious. Though longer-term durability is less clear there is a trend toward using endoscopic measures in those patients with symptomatic GERD who wish to avoid or are at a higher risk for anesthesial fundoplication. As such, the Enteryx procedure is an appropriate procedure for patients such as this patient and is indicated for treatment of his condition. Therefore, I have determined that the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.