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

Physician 1The patient is a 45-year-old female patient with reflux symptoms who has been on multiple proton pump inhibitors (PPIs) and H2 blockers. An EGD performed in October 2002 revealed reflux esophagitis. The patients provider has recommended an Enteryx procedure. The Health Plan has denied authorization for the requested procedure on the basis that it is considered experimental.The efficacy of the Enteryx procedure has not been established. The largest study to date, a multicenter trial of 81 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 2The patient is a 45-year-old woman with longstanding gastroesophageal reflux disease (GERD) symptoms. She has been treated with conventional agents including H2R antagonist and proton pump inhibitor (PPI) drugs. She has received multiple drugs from each category with initial success and eventual failure at symptom control. She has also developed dysphagia, which has not been well explained by an endoscopy that showed only grade A (mild) esophagitis and no stricture. The patient has also undergone 24 pH testing, which showed increased and abnormal 24-hour acid exposure. Motility testing revealed a non-specific esophageal body motility disorder with low amplitude contraction in the distal esophagus. The patient also has a positive ANA, possible autoimmune cholangiopathy, and constipation, which is being treated with Zelnorm. The patient has requested authorization for an Enteryx procedure. The Health Plan has denied the request on the basis that the requested procedure is considered experimental.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. The clinical study on which Food and Drug Administration approval was based involved 85 patients. Though the results were promising this was an observational prospective series, not a controlled study. Patients included in this study were eligible only if they had response to standard doses of PPI, which this patient does not. Furthermore, patients were excluded if they had any motility disorder other than GERD, which this patient does have.There does not appear to be any controlled study of Enteryx at this time. While the Enteryx procedure is an interesting and promising approach to treatment of GERD, it has not been accepted by more than a small minority of physicians treating GERD and its efficacy remains unproven. 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 3The patient is a 45-year-old woman who has a long-standing history of gastrointestinal reflux disease (GERD). The patient underwent her first endoscopy in September 2000, which revealed grade A reflux esophagitis, normal stomach, and normal first portion of the duodenum. The patient was initially treated with Aciphex with improvement in her symptoms. In February 2001, the patient was seen by her gastroenterologist because of persistence of abdominal and epigastric pain after eating despite twice daily Aciphex. The patient underwent esophageal motility and 24-hour pH study. The manometric study was essentially normal, and 24-hour pH study revealed a DeMesster score of 166, with pH<4, 39% of the time. The patient was offered aggressive medical therapy and/or fundoplication. The patient preferred to continue aggressive medical therapy. The patient was prescribed Protonix 40mg twice daily. Because of the persistence of symptoms, the patient was switched over to Nexium 40mg twice daily. The patient during this period underwent another endoscopy, which was essentially remarkable for GERD, small hiatal hernia, and esophageal manometry. The patient was seen in April 2002 for breakthrough symptoms and Zantac was added to her regimen. The patient continues to be symptomatic and wishes to consider alternative treatment with a less invasive surgical procedure. The patients gastroenterologist has recommended the Enteryx procedure for treatment of the patients GERD. The Health Plan has denied authorization for the Enteryx procedure on the basis that it is considered experimental.The patient is a 45-year-old woman who has had GERD since 2000. She has been treated with various PPIs since then, including Aciphex, Nexium, and Protonix. Her current regimen includes Nexium and an H2-blocker at bedtime for breakthrough symptoms. The patient continues to remain symptomatic despite managing her drug regimen. Since the FDA approval of the Enteryx procedure, over 1000 cases have been performed in the US and over 1500 cases have been performed worldwide. Recent medical literature indicates the Enteryx procedure has been widely used outside of clinical trials. The procedure is considered safe and effective, and carries no significant morbidity or mortality. In light of these findings, the Enteryx procedure is the best approach available to the patient and is indicated for treatment of her 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.