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German EndoBarrier reimbursement

GI Dynamics pursues German reimbursement for EndoBarrier

Recent court decisions have reinforced the assertion that payers must support NUB1 new technology payments for EndoBarrier procedures

GI Dynamics has announced that it is continuing to make progress toward full reimbursement in Germany, typically the second largest market for medical technology in the world, and a high priority country for GI Dynamics. German hospitals have made significant legal progress against resistance to EndoBarrier reimbursement.

Recent court decisions have reinforced the assertion that payers must support NUB1 new technology payments for EndoBarrier procedures. An arbitration court ruling had denied NUB payments for Frankfurt Sachsenhausen Hospital based upon the argument that the available clinical evidence did not support the treatment efficacy of EndoBarrier.

The state government of Hessen rejected this court ruling and confirmed that the Consensus Paper 2 of three German medical societies was sufficient evidence to support NUB payment. This position paper outlines the efficacy of EndoBarrier in treating type 2 diabetes and obesity. The conclusions of the paper were publicly reinforced in a Statement by the German Diabetes Society in 2015.

“These legal victories underscore the strong clinical and healthcare system support for EndoBarrier. We appreciate that the hospitals and court system are willing to work through the facts and support the correct administration of NUB new technology payments,” said Scott Schorer, President and CEO of GI Dynamics.

“Multiple hospital systems have taken the time-consuming action of advocating strongly for EndoBarrier reimbursement. These legal actions, together with strong combined consensus support from the German Diabetes Association (DDG), the German Society for General and Visceral Surgery (DGAV), and the German Society for Digestive and Metabolic Diseases (DGVS) underscore the significance of EndoBarrier as a unique treatment option for patients suffering from type 2 diabetes and obesity.”

Registry data

The company recently revealed data from the German EndoBarrier registry, which is run at the University Hospital Hamburg-Eppendorf (UKE), at the EASD (European Association for the Study of Diabetes). Dr Nina Riedel of UKE presented data from 234 patients at the EASD in Munich, Germany.

The results showed that the EndoBarrier produced clinically relevant results, lowering absolute HbA1c mean from 8.5% to 7.2%. This occurred in concert with a lowering of antidiabetic medication (GLP-1) in 78% of patients, and reducing the injected dose of Insulin by 42% on a mean basis.

“Patients significantly benefitted from improvement of HbA1c, reduction of antidiabetic medication, reduction of weight and were able to improve obesity-associated comorbidities,” said Riedel.

Excess weight also dropped by a mean of 15kg, which represented a 29% drop in excess weight.  In addition, a mean drop of 10cm waist circumference (9% drop) was achieved.

EndoBarrier safety profile was clinically acceptable with a 1.7% event rate of hepatic abscess (4/234) and a severe bleeding rate of 0.4%.  All safety-related events were resolved with no long-term complications. 

This interim analysis included 234 patients and the Registry continues to expand, and has input more than 300 patients to date.

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