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

Physician 1: The patient is a 37-year-old male with chest pain, who has had a response to PPIs, but does not wish to take them any longer and it has been recommended to him that the Enteryx procedure for managing GERD may be a reasonable option to pursue. His diagnosis of GERD is questionable at best as his symptoms are not typical and his objective measures not diagnostic. A 48-hour Bravo study has a total intraesophageal acid exposure of ~2%, which is well within the normal range. Further, there was no esophagitis on endoscopy and a completely normal manometry. The Health Plans reason for denial is based on an investigational nature of the proposed procedure and lack of controlled trial data.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. However, Enteryx has not been evaluated in patients with atypical GERD symptoms such as chest pain. Furthermore, there are no data beyond two years regarding the durability of Enteryx and it is clear that loss of efficacy does occur in some patients. As such, there is insufficient evidence to date that Enteryx is beneficial for treatment of patients such as this patient.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 37-year-old male who has a history of chronic GERD with heartburn, relieved by the use of pantoprazole. He has had an EGD, which did not reveal esophagitis or Barretts esophagus. He also underwent pH testing, which showed a DeMeester score of 16, which is just slightly elevated above normal. The patient reports pantoprazole gives him unbearable side effects including swollen gums, sleeplessness, constipation, uncomfortable sex life, depression and over all discomfort. These are unusual side effects from a medication for which the common non-serious side effects are headache or nausea. There is no indication that the patient has attempted use of any of the four other class-similar drugs available.The patients provider has recommended the patient undergo the Enteryx procedure. The Health Plan has denied coverage for the requested procedure on the basis it is considered investigational.Enteryx injection for control of symptoms of GERD is one of a number of alternatives to accepted medication or fundoplication surgery for patients who have mild symptoms, absence of significant hiatal hernia, no evidence of Barretts esophagus or other complications, and good response to proton pump inhibitor medications. Like other treatments, there are no comparisons to established treatment such a fundoplication and no long-term follow-up.The Enteryx procedure is attractive for its relative simplicity involving injection into the muscular tissue of the lower esophageal sphincter using conventional endoscopy. Adverse effects and complications include retrosternal chest pain, dysphagia, fever, belching, bloating and flatulence, and bad odors in some patients. There have been at least two deaths reported involving esophageal abscess and gastrointestinal bleeding.The results of a sham controlled randomized trial of Enteryx are now available. The trial showed a GERD healthrelated quality of life heartburn score was more commonly improved in the Enteryx group than sham controls. Furthermore, 68% of Enteryx versus 41% of sham treated patients were able to discontinue their PPI drugs completely. Enteryx apparently does not reduce esophageal acid exposure.In the case of this patient, the submitted information indicates he has tried only one of the five PPI medications commercially available. Though the requested procedure is promising, there is inadequate long-term data demonstrating Enteryx is superior to conventional treatment. 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 3: The patient is a 37-year-old male with chronic heartburn and chest pain. An EGD showed incompetent lower esophageal sphincter with no evidence of Barretts esophagus. A manometry showed normal peristalsis progression with adequate amplitude. The patient has been taking Protonix but reports side effects of swollen gums, sleeplessness, constipation, depression and uncomfortable sex life.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.