New Study Shows LINX Reflux Management System Treatment Lowers Overall Medical Expenses for GERD and Other Health Issues

Treatment with Ethicon’s** LINX Reflux Management System reduced medical costs more than laparoscopic Nissen fundoplication (LNF), a more invasive anti-reflux surgery, and more than offsets the slightly higher cost of the procedure, according to a new study presented here today at the 2019 Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES 2019).

The research was partially funded by Ethicon, part of Johnson & Johnson Medical Devices Companies**, in collaboration with Highmark Health’s VITAL Innovation Platform, a test-and-learn environment for health innovations.

“The higher initial cost of a LINX procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which made getting insurance approvals challenging,” said lead researcher Blair Jobe^, MD, Director, Esophageal and Lung Institute at AHN. “This study suggests that perception may be short-sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

The prospective observational study was performed at Highmark Health’s Allegheny Health Network (AHN), a health system serving western Pennsylvania, in conjunction with Highmark Inc., the region’s largest health insurance company. Researchers compared the total procedural cost and the disease-related and overall medical claim costs 12 months before and 12 months after a LINX procedure (180 patients) or LNF (1,131 patients).

The study found the mean PMPM (per member per month) medical reimbursement claims related to upper gastrointestinal (GI) disease one year after LINX dropped by 66 percent ($305 to $104) compared to 46 percent ($233 to $126) after LNF. Overall PMPM medical reimbursement claims decreased by 10.7 percent for LINX patients and only by 1.4 percent for LNF patients. Specific reimbursements for proton pump inhibitors (PPIs), acid suppression drugs for gastrointestinal reflux disease (GERD), dropped by 95 percent after LINX and by 90 percent after LNF.

The median cost of a LINX procedure was $13,522 (mean $14,379) and $13,388 (mean$13,691) for LNF, a difference that researchers say is offset or surpassed by a lower cost of care for the insurer in the one year following surgery.

LINX is a flexible ring of small magnets surgeons place around the lower part of the esophagus, the body’s natural barrier to reflux, during a minimally invasive procedure. The magnetic ring expands when a patient swallows to allow food to enter the stomach but then contracts to prevent stomach contents from flowing back into the esophagus and causing GERD, a condition that affects about 20 percent of people in the United States.[1] In LNF, a surgeon wraps a portion of the upper stomach (fundus) around the lower part of the esophagus to help prevent acid from moving up into the esophagus.

“This study demonstrated that the LINX System was cost effective and should be more widely covered by insurers,” said Tom O’Brien, President, Worldwide Endomechanical, Ethicon. “Ethicon will continue to help support studies that enable clinicians, patients, insurers and health systems to make the best possible decisions about which treatments work best for which patients and at what cost.”

Previous studies on LINX showed 88 percent of patients reported that bothersome heartburn had been eliminated five years after treatment,[2] 85 percent were free from dependence on daily reflux medication[3] and 99 percent of patients eliminated regurgitation,[4] a common symptom of GERD. Patients also report significant improvements in quality of life.[5]

The LINX Reflux Management System is indicated for those patients diagnosed with GERD as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy. LINX requires a surgical procedure and is associated with potential risks, contraindications and life style modifications.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.

**Comprising the surgery, orthopaedics, vision and interventional businesses within the Johnson & Johnson’s Medical Devices segment

^Dr Blair Jobe is a consultant for Ethicon

References

[1] https://www.niddk.nih.gov/health-information/digestive-diseases/acid-reflux-ger-gerd-adults/definition-facts

[2] Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, bothersome heartburn was 89% at baseline and decreased to 11.9% at 5 years. (p<0.001)

[3] Ganz R. Edmundowicz S, Taiganides P, et al. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016. 14(5):671-7. Based on a study observing 100 patients who were implanted with LINX, daily use of PPIs decreased to 15.3% at 5 years. (p<0.001)

[4] Ganz R. Edmundowicz S, Taiganides P, et al. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016. 14(5):671-7. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, regurgitation was 57% at baseline and decreased to 1.2% at 5 years. (p<0.001)

[5] Ganz R. Edmundowicz S, Taiganides P, et al. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016. 14(5):671-7. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, there was a significant improvement in the median GERD-HRQL score at 5 years, as compared with baseline, both with and without PPI use, 4 vs 11 and 27 respectively (p<0.001).