Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD (Gastroesophageal Reflux Disease).
Treatment: Transoral incisionless fundoplication (EsophyX).
The insurer denied transoral incisionless fundoplication (EsophyX).
The determination is upheld.

This is a patient who has chronic gastroesophageal reflux disease (GERD). He took several proton-pump inhibitors (PPIs) without relief of his symptoms. He has a 2 centimeter (cm) hiatal hernia and evidence of esophagitis on esophageal biopsies. An esophageal potential hydrogen (pH) study is not provided. The attending provider would like to do a transoral incisionless fundoplication (TIF) procedure to treat this patient's GERD.

At issue is whether the transoral incisionless fundoplication (EsophyX) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment transoral incisionless fundoplication (EsophyX) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The patient has chronic gastroesophageal reflux disease (GERD).

There are two endoscopic interventions for GERD that are currently available in the United States they are: the Stretta procedure (Mederi Therapeutics, Greenwich, Connecticut) and transoral incisionless fundoplication (TIF) (Endogastric Solutions, Redmond, Washington). In studies evaluating these endoscopic interventions, patients with significant structural Esophagogastric junction disruption (e.g., hiatus hernia larger than 2 cm), significant esophagitis (Los Angeles Classification of GERD grade C or D), and GERD complications (Barrett's esophagus (BE), peptic stricture) were excluded. In a multicenter study that compared TIF to a sham procedure and PPI therapy, esophageal pH decreased and regurgitation was better resolved 6 months after TIF, although TIF did not reduce GERD symptom scores.

A randomized controlled trial of transoral incisionless fundoplication versus (vs) proton pump inhibitors for treatment of gastroesophageal reflux disease by Witteman and colleagues showed that although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved. Similarly, in a systematic review and network meta-analysis of trials of patients with GERD, Richter and colleagues found laparoscopic Nissen fundoplication (LNF) to have the greatest ability to improve physiologic parameters of GERD, including increased lower esophageal sphincter (LES) pressure and percent time at pH less than (<) 4. Although transoral incisionless fundoplication (TIF) produced the largest increase in health-related quality of life, this could be due to the shorter follow-up time of patients treated with TIF vs LNF or PPIs. TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits versus risks, the authors do not recommend it as a long-term alternative to PPI or LNF for treatment of GERD.

According to the updated American College of Gastroenterology guidelines (2021) for the management of GERD, randomized trials have shown that TIF is effective for treating troublesome regurgitation, but the long-term benefit of TIF is not established and questionable. One systematic review and meta-analysis on the use of TIF for refractory GERD found that TIF resulted in significant improvements in GERD health-related quality of life and DeMeester scores, enabling 89 percent (%) of patients to discontinue PPIs. However, another systematic review and meta-analysis on the use of TIF for the treatment of GERD found that although symptoms responded to TIF significantly more often that to PPIs/sham, TIF did not result in significant improvement in esophageal acid exposure and most patients resumed PPIs at reduced dosages during long-term follow-up. The incidence of serious adverse events (perforation and bleeding) was 2.4%, and the rate of total satisfaction with TIF was 69 percent (%) by 6 months.
Therefore, although endoluminal antireflux techniques represent potentially new therapeutic indications for gastrointestinal (GI) endoscopy, prospective trials comparing these therapies with existing medical and surgical options by using objective measures of GERD as the primary endpoint could be useful in further defining the clinical role of these procedures. Appropriate patient selection and endoscopist experience and training should be carefully considered before pursuing these therapies.