Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 64-year-old man with gastroesophageal reflux disease (GERD). His symptoms include difficulty swallowing and nocturnal and diurnal reflux. He is taking Nexium and ranitidine. On 9/22/04, he had an endoscopy with the finding of normal esophagus. The patient has requested authorization and coverage for an Enteryx procedure. The Health Plan has denied the request on the basis that the Enteryx procedure is considered investigational. The Enteryx procedure has been evaluated in a large, uncontrolled, multicenter, international trial and found to be effective in most patients in terms of controlling their symptoms, discontinuing their PPIs and other anti-reflux medications, and improving their quality of life. More than 1,500 patients have undergone Enteryx therapy. The United States trial data now extends out to two years post procedure. Results show significant improvement in intra-esophageal acid exposure with 38% of patients still normalized at 12 months and PPI use decreased or eliminated in 70% of patients at 24 months. A United States sham study is under way and complete analysis of this trial should be available soon. However, all the patients included in these trials are patients with mild disease responsive to PPIs. The use of the Enteryx procedure for refractory patients, such as this patient, as an adjunct to medical therapy in individuals with persistent symptoms should be avoided until supported by data. 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 2: The patient is a 64-year-old man with gastroesophageal reflux disease (GERD) who wishes to undergo an Enteryx procedure for his symptoms. Treatment notes from his gastroenterologist in 1996 indicate he is an overweight man who drinks three cups of coffee a day and smokes two packs of cigarettes. That visit was for a possible colon polyp and no mention of GERD was made. Later notes, beginning in 2004, indicate that he has trouble swallowing, is taking Nexium and ranitidine, and is being treated for depression. On 9/22/04, he had an endoscopy with the finding of normal esophagus. He was treated with agents including Zelnorm and Reglan without improvement. An Enteryx procedure has been recommended for treatment of his symptoms. The Health Plan has denied the request on the basis that the requested procedure is considered investigational. The Enteryx procedure has not been evaluated in a randomized, controlled, blinded trial. It does appear to reduce symptoms of heartburn and reflux but not to reduce acid exposure in the esophagus. Long-term results are not known. It is an attractive procedure in that it requires basic endoscopic skills rather than specialized procedures and has been relatively safe; there has been one death reported. The trial on which FDA approval was based included patients who were responsive to PPIs and it is not clear whether this patient is PPI responsive based upon the notes provided. In addition, the trial excluded patients with significant hiatal hernias. In the case of this patient, it is not known if he has significant reflux as a 24-hour pH study has not been provided. However, there was no acid reflux related esophagitis noted or documented in the submitted materials. It appears this patient has options with standard, accepted therapy and there is not sufficient information available to conclude that the Enteryx procedure is likely to be superior to standard therapy. 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 3: The patient is a 64-year-old male with a history of reflux for the past five years. He is taking Nexium on a daily basis. It is said that he has nocturnal reflux and difficulty swallowing. An EGD performed in September 2004 showed gastritis. The description also indicated the esophagus was relatively normal with no evidence of inflammation or yeast infection. The patient has apparently been tried on Zelnorm and Reglan, but he was not able to tolerate these medications and they did not improve his symptoms. A 24-hour pH study or a manometry study has not been included in the information provided. The patient wishes to undergo an Enteryx procedure for relief of his symptoms. The Health Plan has denied coverage for the requested procedure on the basis it is considered experimental for treatment of the patients condition. The efficacy of the Enteryx procedure has not been established. A January 2004 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 occurred. Though these results are promising, further studies are needed involving 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.