The G-BA has initiated discussions for a § 137e study trial on transcutaneous vagus nerve stimulation for drug-resistant epilepsy
Following a § 137e (7) application by the manufacturer, the Federal Joint Committee (G-BA) decided that the benefit of transcutaneous vagus nerve stimulation in drug-resistant epilepsy cannot be considered proven, yet. However, the method shows the potential of a required treatment alternative. The G-BA will now discuss a § 137e guideline and specify the cornerstones of a co-funded trial study. Affected societies and manufacturers are thereby prompted to submit their perception of the method. Furthermore, the G-BA aims to determine manufacturers that want to participate in the study and cover a part of the study overhead costs. The intervention itself will be reimbursed.