Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease) 
Treatment: Linx Reflux Management System
The insurer denied the Linx Reflux Management System
The denial is upheld.

The patient is a male. He has the diagnosis of GERD (gastroesophageal reflux disease) and has failed conventional therapies as treatment for this condition. As such the provider has requested the provision of the LINX system as treatment for this condition. The plan declined coverage of this placement as it was deemed experimental/investigational in nature.

No, the health plan should not cover the Linx procedure.
Laparoscopic Nissen fundoplication is now considered the standard surgical approach for treatment of severe gastroesophageal reflux disease (GERD). GERD (gastroesophageal reflux disease) is increasingly prevalent and costly, and its effects are experienced daily by up to 10% of the population. The pathophysiology of GERD (gastroesophageal reflux disease) is not due to acid overproduction but rather mechanical dysfunction centered around the lower esophageal sphincter. Furthermore, the mainstay of GERD (gastroesophageal reflux disease) treatment, proton pump inhibitors, have come under scrutiny due to worrisome side effects [2, 3]. More recently, laparoscopic magnetic sphincter augmentation of the lower esophageal sphincter has been proposed as an additional surgical option. Like the Nissen fundoplication, it relies on 360 buttressing of the lower esophageal sphincter, but with the potential for fewer long-term adverse effects. [Ganz et. al.]

A new surgical option became available when the US Food and Drug Administration (FDA) approved the LINX device for implantation. This is a magnetic sphincter augmentation system designed to support the lower esophageal sphincter in much the same way as a fundoplication. Unlike a fundoplication, the device is dynamic, being made up of multiple interlinked titanium-coated rare-earth magnets. Results from clinical trials have been very promising, with excellent results relative to control of reflux and with fewer adverse effects (eg, dysphagia, gas-bloat) that may accompany a traditional fundoplication. Additionally, the safety profile is evidenced to be very good. [Lipham et. al.]

Current evidence consists of two uncontrolled and unblinded manufacturer-sponsored studies that were submitted to the FDA (United States Food and Drug Administration) for device approval. These single-arm series are of limited usefulness for determining treatment efficacy and provide no information on the comparative efficacy of this procedure with other GERD (gastroesophageal reflux disease) treatments. The subjective outcome measures used in these two trials, such as the GERD (gastroesophageal reflux disease)-HRQL (Health Related Quality of Life) scores, may be biased due to placebo effects with this study design. The objective measure of esophageal pH (potential of hydrogen) shows modest improvement compared to baseline, but this is a physiologic measure with uncertain clinical significance. Dysphagia was common in treated patients, although serious adverse events were less common, and the smaller feasibility study did not identify any serious safety concerns at up to 4 years of follow-up.

The FDA (United States Food and Drug Administration) has required 4 years of follow-up on the 100 subjects in the pivotal study. Independent assessment of the device by non-industry sources would also allow greater certainty. The evidence at this time is insufficient to permit conclusions concerning the effect of this device on net health outcome.

The expert panel convened by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee concluded the following:

The incidence of initial dysphagia following LINX implantation is high. Difficulty swallowing was more commonly reported at 12 and 24 months following LINX implantation than at baseline.  Patients should be advised about the possibility that it may be more difficult to swallow following surgery, and that this symptom may persist.  The LINX device may provide an option currently lacking in clinical practice for patients with medically refractory GERD (gastroesophageal reflux disease) who have not yet progressed to end-stage reflux disease with associated complications. Direct comparative studies between the LINX procedure and Nissen fundoplication will be needed. On the basis of the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory GERD (gastroesophageal reflux disease).

On the other hand, the American College of Gastroenterology (ACG)'s guidelines on "Diagnosis and management of gastroesophageal reflux disease" (Katz et al) did not agree with the expert opinion rendered by the SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Technology and Value Assessment Committee.  The ACG (American College of Gastroenterology) guidelines stated that "Endoscopic therapies for GERD (gastroesophageal reflux disease) have been developed but have not demonstrated long-term efficacy.  These therapies included radiofrequency augmentation to the lower esophageal sphincter, silicone injection into the lower esophageal sphincter, and endoscopic suturing of the LES (lower esophageal sphincter).  None of these therapies demonstrated long-term improvement in esophageal pH (potential of hydrogen) levels or the ability for patients to stop antireflux therapy and were subsequently removed from the US marketplace.  Recent alternative approaches have included transoral incisionless fundoplication, a suturing device designed to create a full thickness gastroesophageal valve from inside the stomach.  Unfortunately long-term data regarding efficacy of this device are limited to a small number of subjects and short duration of follow-up.  A recent study suggested that at 36 months of follow-up, the majority of patients had required additional medical therapy or a revisional fundoplication.  Sphincter augmentation using the LINX Reflux system constructed of titanium beads has shown efficacy up to 4 years in the reduction of the amount of pathologic esophageal acid exposure in a small number of subjects.  This device has been approved by the FDA (United States Food and Drug Administration) based on a clinical study in 100 GERD (gastroesophageal reflux disease) patients.  This study found that performance of LINX resulted in consistent symptom relief and pH (potential of hydrogen) control with markedly fewer side effects than traditional laparoscopic fundoplication in well-selected patients.  More data are required before widespread usage can be recommended.  The usage of current endoscopic therapy or transoral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical therapy."

Given the limited studies available, the need for long-term evaluation, and the controversy between SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) and ACG (American College of Gastroenterology), the LINX procedure is still considered experimental/investigational, has not yet been proven medically appropriate and has not been shown to have beneficial effects on health care outcomes.

No, the Linx procedure is not more beneficial.