Beginning May 1, 2025, Australians suffering from treatment-resistant depression will have access to a new medication, esketamine, under the Pharmaceutical Benefits Scheme (PBS). This nasal spray, marketed as Spravato, is a form of ketamine and is designated for adults whose major depressive disorder has not sufficiently improved after trying at least two different antidepressants at appropriate doses.
This marks the first introduction of a new class of medication for major depression funded by the Federal Government in thirty years. Professor Ian Hickie, co-director of the Health and Policy, Brain and Mind Centre at Sydney University, expressed support for this development, stating, “This is a governmental initiative that directly addresses the needs of individuals enduring severe depressive episodes who have not found relief through conventional treatments.”
In Australia, approximately one in seven people experience depression, with about one-third classified as having treatment-resistant depression. This condition is characterized by prolonged depressive episodes, increased suicidal thoughts, and an inability to experience pleasure, leading to a higher risk of recurrent depression throughout one’s life.
Once available on the PBS, it is anticipated that around 30,000 Australians will qualify to receive esketamine, which will cost $7.70 per dose for pension or concession card holders and $31.60 for others.
Despite the excitement surrounding this new treatment, Dr. Cathy Andronis, Chair of the RACGP Specific Interests in Psychological Medicine, raised concerns about its accessibility. She highlighted the need for adequate resources to manage patients effectively, noting that many have previously tried multiple medications without success. “Esketamine can be effective for certain patients with complex conditions, but it requires careful monitoring by experienced clinicians due to the associated risks,” Dr. Andronis said.
Clinical guidelines stipulate that esketamine must be prescribed alongside a newly initiated oral antidepressant and administered under clinical supervision. For the first month, patients will receive the spray twice a week, followed by weekly sessions for the next month, and then weekly or bi-weekly treatments until symptoms improve. Treatment should continue for at least six months thereafter.
Esketamine functions as a glutamate receptor modulator, increasing glutamate levels, a neurotransmitter linked to mood regulation. The nasal spray allows for swift absorption through the nasal passages and into the bloodstream, facilitating rapid action. However, the requirement for clinical supervision limits its availability to certified centers equipped to administer the treatment safely.
Currently, access to psychiatrists is limited, and few general practitioners (GPs) have the necessary experience in administering esketamine. Dr. Andronis noted, “The risk profile and monitoring requirements mean that most patients may still have difficulty accessing this treatment,” pointing out that only a small number of GPs are equipped to manage these complex cases.
Recent observational studies indicated that over 80% of patients showed improvement or near elimination of symptoms within four weeks of beginning esketamine treatment, with 28% experiencing symptom relief within the first 24 hours. However, ongoing research is needed to assess the treatment’s long-term effects and its relationship with suicidality, especially for patients with suicidal thoughts prior to treatment.
Certain contraindications exist for the use of esketamine, particularly for patients at risk of elevated blood pressure or intracranial pressure, such as those with a history of aneurysms. Initially registered with the Therapeutic Goods Administration in 2021, esketamine took four years and several attempts to gain PBS funding approval.
The introduction of esketamine represents a notable advancement in the treatment landscape for those struggling with treatment-resistant depression, yet ongoing efforts are required to ensure that these patients receive timely and effective care.
