AGA Favours Transoral Fundoplication for GERD, Now Reimbursement for EsophyX®

Gastroesophageal solutions specialist, EndoGastric Solutions® (EGS), tells us that the American Gastroenterological Association (AGA) has issued a Technology Coverage Statement on Minimally Invasive Surgical Options for GERD that favours Transoral incisionless fundoplication (TIF®) a procedure that can be performed using the EGS EsophyX® system. Since this announcement, EGS issued a statement saying it had gained a medical coverage policy for Transoral Incisionless Fundoplication (TIF®) procedures effective July 15th, from Health Care Service Corporation (HCSC), a top commercial health insurer in the U.S.

Background

Gastroesophageal reflux disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux into the esophagus, causing heartburn and possible injury to the esophageal lining. GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 80 million people at least once per month in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g., diet, scheduled eating times and sleeping positions) and escalating doses of prescription medications for prolonged periods of time.

Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair another treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.

So to the AGA statement, which can be found in full here. Randomized controlled trial data from Transoral incisionless fundoplication (TIF®) performed using the EndoGastric Solutions’ EsophyX® device system was cited in the AGA Statement, which is intended to be a framework for treatment of GERD. The key point from the statement as it pertains to the procedure is that Transoral fundoplication delivers patient outcomes similar to those provided by conventional antireflux surgery (ARS) procedures and does not limit future treatment options. It concludes that the three‐year plus evidence [for the TIF procedure] is sufficient to demonstrate sustainable improvement in health outcomes, symptom relief, decrease in PPI utilization and improvement in esophageal pH with transoral fundoplication.

Company comments

“This demonstrates key society support for the TIF procedure as an anti-reflux procedure option for chronic GERD suffers,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We are grateful to the AGA and its panel of experts to issue such a review in advance of updates to existing society guidelines.”

Healthcare Economist comments

“This statement by the AGA is important for advocacy work with payers,” said Philip Macdonald, Vice President, Healthcare Economics, Policy & Reimbursement. “Publishing new guidelines can be time consuming and cost prohibitive. The evolution of data-proven technologies to treat chronic diseases is accelerating so the Technology Coverage Statement by the AGA can help fill the gap during the society’s guideline review cycle. This ensures society membership is able to provide safe and effective treatments for chronic disease sufferers sooner.”

Source: Business Wire

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