Australians living with depression that cannot be relieved by antidepressant tablets will receive affordable access to a new nasal spray treatment, the first new type of medicine for major depression to be funded by the government in three decades.
From 1 May, SPRAVATO® (esketamine) will be available through the Pharmaceutical Benefits Scheme (PBS) for adults with treatment-resistant depression (major depressive disorder which has not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current moderate to severe depressive episode). It is used in conjunction with a newly-initiated oral antidepressant.
Up to 30,000 Australians are expected to receive SPRAVATO through the PBS at a cost of just $7.70 (pensioner or concession card) or $31.60 (general patients) for each dose of the medicine.
Professor Ian Hickie AO, Co-Director of Health and Policy, Brain and Mind Centre, University of Sydney, welcomed the reimbursement of SPRAVATO, noting that “for the first time, we have a government funded medicine specifically for people trapped in an acute depressive episode despite treatment with multiple antidepressants”.
“Depression of this nature affects every aspect of a person’s life and can make it seem as though life is not worth living,” said Professor Hickie. “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 healthcare needs. Affordable access to treatment is essential if we are to help them out of what is often a dark, deep and dangerous hole,” he said.
Depression affects one-in-seven Australians. It is estimated that a third of Australians living with depression cycle through multiple antidepressant treatments without satisfactory relief, and are therefore deemed to have ‘treatment-resistant depression’.
Compared to people with major depressive disorder, those with treatment-resistant depression tend to experience more severe symptoms, significantly longer depressive episodes, suicidal thoughts, an inability to experience joy, and a higher number of depressive episodes during their lifetime.
SPRAVATO is a glutamate receptor modulator. Glutamate is the most abundant neurotransmitter (chemical messenger) in the brain and is involved in a person’s mood and thought processes. SPRAVATO works by increasing glutamate levels in the brain to stimulate and restore message transmission within the brain.
This treatment is only available through certified centres that have the capabilities needed to safely administer the treatment and monitor patient safety. Under clinical supervision, the medicine is administered via nasal spray, allowing it to be absorbed by the lining of the nasal passages and move into the blood stream.
The drug is administered twice-a-week for the first month, weekly for the next month, and then weekly or fortnightly until depressive symptoms improve, at which point treatment should continue for at least six months.
Johnson & Johnson Innovative Medicine ANZ Managing Director, Joana De Castro said the PBS listing of SPRAVATO is “long overdue”.
“Four years after TGA registration and following four funding submissions, we are pleased that Australians with treatment-resistant depression will at last have access to SPRAVATO through the PBS,” she said.
As with all medicines, SPRAVATO may cause side effects. When used along with an oral antidepressant, the most common side effects include: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.
SPRAVATO is administered under the direct supervision of healthcare professionals at a certified treatment centre. During and after administration, patients must be monitored for blood pressure, sedation and dissociation until clinically stable.
They should not drive or operate machinery until the following day. SPRAVATO cannot be used by patients who would be placed at risk by increases in blood pressure or intracranial pressure (for example, those with a history of aneurysm) and those with a sensitivity to the ingredients.
Careful monitoring is required for patients with suicidal ideation prior to commencement of treatment.