Applications

1491 – Vagus nerve stimulation for chronic major depressive episodes

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

New MBS item.

Service or technology in this application

VNS 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).

Type: Therapeutic

Medical condition this application addresses

Major 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.

Meetings to consider this application

  • PASC meeting: 8 December 2017
  • ESC meeting: 8 June 2018
  • MSAC meeting: 26 - 27 July 2018