New medication for treatment resistant depression added to PBS

Australians with depression who have not responded to traditional medications will soon have access to a new type of treatment under the Pharmaceutical Benefits Scheme (PBS).
 
Esketamine (sold as Spravato) uses a form of ketamine administered via a nasal spray and will be available through the PBS from 1 May for adults with treatment resistant depression.
 
To be eligible, patients must have a major depressive disorder that has not responded adequately to at least two different antidepressants of adequate dose and duration.
 
It is the first new type of medicine for major depression to be funded by the Federal Government in three decades.
 
Professor Ian Hickie, co-director of Sydney University’s Health and Policy, Brain and Mind Centre, welcomed the announcement.

Professor Hickie has been heavily involved in Spravato research, and has authored papers about its impacts on people living with major depressive disorder.
 
‘For the first time, we have a Government-funded medicine specifically for people trapped in an acute depressive episode despite treatment with multiple antidepressants,’ he said.
 
‘Depression of this nature affects every aspect of a person’s life and can make it seem as though life is not worth living.
 
‘When multiple treatment options have not delivered relief, that feeling can be compounded, leaving people with little hope.
 
‘People with treatment resistant depression have complex and often urgent mental health care needs. Affordable access to treatment is essential if we are to help them out of what is often a dark, deep and dangerous hole.’
 
In Australia, depression affects one in seven people, and one-third are estimated to have treatment resistant depression. This can result in more severe symptoms including significantly longer depressive episodes, suicidal thoughts and an inability to experience joy. They are also likely to have a higher number of depressive episodes throughout their lifetime.
 
Once on the PBS, up to 30,000 Australians living with depression are expected to be eligible to receive esketamine, costing $7.70 per dose for pension or concession card holders and $31.60 for all other patients.
 
However, Dr Cathy Andronis, Chair of RACGP Specific Interests Psychological Medicine, told newsGP she still has concerns around accessibility.
 
While she welcomes the new and affordable treatment option, the GP says more consideration needs to be given to the process of appropriately managing the condition, which includes investment into longer consultations.
 
‘Often these patients have tried most, or every available medication already, without much success,’ Dr Andronis told newsGP. 
 
‘Esketamine is effective for some patients with complex presentations but requires close monitoring by skilled clinicians to maintain safety as there are considerable risks along with the potential benefits.
 
‘It also needs to be given alongside good evidence-based psychotherapy, so definitely requires longer consultations with all the costs involved in those – both to the patient, as well as the GP.’
 
According to clinical guidelines, esketamine must be used in conjunction with a newly initiated oral antidepressant and administered under clinical supervision via nasal spray.
 
For the first month, it is administered twice a week, followed by weekly for the next month, and then weekly or fortnightly until depressive symptoms improve. From that point, it is recommended that treatment continues for at least six months.
 
A glutamate receptor modulator, esketamine works by increasing glutamate levels – a neurotransmitter involved in a person’s mood and thought processes – to stimulate and restore message transmission within the brain.
 
The nasal spray mechanism allows the treatment to be absorbed by the lining of the nasal passages and move into the blood stream.
 
As the treatment must be administered under clinical supervision, it is only available through certified centres that have the capabilities to safely administer it and monitor patient safety.
 
But with access to psychiatrists currently limited, and few GPs experienced in administering the treatment, Dr Andronis says it is likely ‘most patients will still find it difficult to access’.
 
‘It is restricted due to its risk profile and requirement for close monitoring,’ she said.
 
‘Only a few GPs have experience in prescribing and managing the complexity, and our current Medicare system disincentivises us to offer this treatment.’
 
A recent observational study on intranasal esketamine, published last month, found just over 80% of the 189 patients evaluated saw an improvement, or an almost elimination, of symptoms within the first four weeks of treatment. While 28% had an improvement in depressive symptoms within the first 24 hours.
 
However, research is ongoing, with questions persisting around the treatment’s impact on suicidality and its long-term effects, with careful monitoring advised for patients with suicidal ideation prior to commencement of treatment.
 
There are also contraindications to using esketamine that doctors must be aware of, with the treatment not suitable for patients who would be placed at risk by increases in blood pressure or intracranial pressure, such as those with a history of aneurysm.
 
Esketamine, under the brand name Spravato, was first registered with the Therapeutic Goods Administration in 2021 and has taken four years and several attempts to be given approval for funding under the PBS.
 
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