Description of Medical ServiceVNS device consists of an implanted pacemaker-like pulse generator and a nerve stimulation electrode, which deliver intermittent stimulation to the left vagus nerve; the same technology has been accepted by MSAC for refractory epilepsy. The proposed services cover implantation, programing, explantation / repositioning and battery replacement.
Implantation requires two small incisions to:
1. Place the pulse generator under the skin below the collar bone, and
2. Wrap the electrode around the left vagus nerve in the neck. The procedure takes 1-2 hours under general anaesthesia in an inpatient setting, usually by a neurosurgeon.
Post-implantation, the patient must visit their specialist psychiatrist for dose (pulse) titration to clinical efficacy. Once a therapeutic dose is established, 1-2 visits per year are recommended thereafter for monitoring purposes. The therapy is continuous and long-term with a typical battery life of up to 10 years (replaceable for continuing treatment).
Description of Medical ConditionMajor depressive disorder (MDD) is a common psychiatric disorder, characterised by depressed mood, loss of interest and enjoyment and other psychological and somatic symptoms. MDD causes substantial psychosocial dysfunction and high individual mental strain, as well as excess morbidity and mortality – the risk of suicide is considerable.
Initial treatment involves antidepressant medication. Around 30% of patients do not respond to multiple treatment steps and are considered as treatment resistant. Even if they achieve a response, these patients have a higher likelihood to relapse. Tolerability issues also negatively impact treatment outcomes.
Treatment resistant depression (TRD) is defined as having failed to achieve adequate response after at least two appropriate antidepressant trials from two different pharmacological classes (Berlim and Turecki 2007). VNS is proposed for funding for patients who have failed at least 4 lines of therapy – difficult-to-control subpopulation with significant unmet clinical need due to the lack of viable treatment alternatives.
Reason for ApplicationNew MBS item
Medical Service TypeTherapeutic
Previous Application NumberNot applicable
Application FormApplication Form (Word 246 KB)
Application Form (PDF 1169 KB)
Public Summary DocumentPublic Summary Document (Word 157 KB)
Public Summary Document (PDF 1069 KB)