Appeal type: Experimental/Investigational
Decision: Upheld

Digestive System/Gastrointestinal
Surgical Services

This patient is a male with a body mass index (BMI) of 18 kilograms per square meter (kg/m2) with a 4-year history of gastroesophageal reflux disease. His symptoms include primarily chest pain and cough. He has been treated with lifestyle modification, diet modification and proton pump inhibitor (PPI) (Omeprazole) therapy without complete resolution of symptoms. He sought consultation and has completed evaluation with:
1) pH study was performed (off medication) that showed elevated esophageal acid exposure. The DeMeester score was 18.8 (normal less than [<] 14.7). There was strong symptom correlation.
2) Esophageal manometry  showed no hiatal hernia. There was adequately preserved esophageal peristalsis. Distal contractile integral was normal.
3) Esophagogastroduodenoscopy (EGD)  showed an irregular gastroesophageal (GE) junction with reflux esophagitis. There was no hiatal hernia. Pathology showed no intestinal metaplasia.
The treating doctor has proposed Stretta for the treatment of GERD with laryngopharyngeal reflux.
The subject under review is whether the procedure is expected to be more beneficial to the patient than any standard treatment.

The health plan's determination is upheld.

No. It cannot be said based on the current evidence-based literature that the proposed procedure is likely to be more beneficial than any other standard treatment for the insured's life threatening or disabling condition or disease.
The most recent statement provided by The American Society of Gastrointestinal Endoscopy (ASGE) in June 2015 states that endoscopic anti-reflux therapy such as Stretta is a potential treatment based on the 2012 review. [ASGE Standards of Practice, Committee]
In 2015 there were three reviews published that discussed the relative safety and effectiveness of the Stretta procedure compared with other endoscopic procedures delivered through the mouth, drug treatment (generally proton-pump inhibitors), and fundoplication. [Hopkins, Lipka, Lo]
One was a systematic review and meta-analysis of clinical trials conducted with Stretta, done in response to the 2013 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) review (which did not include meta-analysis). [Lipka] This review found that quality of studies that had been conducted was generally poor, and that compared with sham therapy (used a placebo for medical device clinical trials), the procedure did not change time spent at a pH less than 4, did not increase lower esophageal sphincter pressure (LESP), did not allow people to stop treatment with proton-pump inhibitors, and did not improve health-related quality of life.
The publication by Lo was a literature review, and noted the long history of use of Stretta, and found the procedure to be safe and effective. This review noted that the procedure complemented drug treatment and fundoplication and provided a useful option in the care of patients with GERD.
The third 2015 review was also a literature review that noted the long safety record but concluded only that the procedure "may be effective in reducing symptom burden and quality of life scores up to 8 years post-intervention. However, there does not appear to be any sustained improvement in objective outcomes and there is no evidence that Stretta results in improved outcomes as compared to surgical intervention". [Hopkins]
Stretta uses energy to heat the tissue of the gastroesophageal (GE) junction, causing it to swell and stiffen. The mechanism of action of Stretta was not understood as of 2015, but it was thought that perhaps the heat causes local inflammation, collagen deposition and muscular thickening of the lower esophageal sphincter (LES) and that it may disrupt the nerves of the GE junction. [Hopkins]
While Stretta is not experimental based on Food and Drug Administration (FDA) approval, the current body of body of peer-reviewed literature is equivocal with regard to the efficacy of this intervention. The efficacy of Stretta is not definitively known based on the most recent published literature.
Therefore, this therapy is not definitively or likely to be more beneficial than other standard treatment for the patient's life threatening or disabling condition or disease.