Is Ketamine Therapy Legal in Australia? A Complete Guide
Ketamine therapy is legal in Australia, but access is tightly controlled and governed by strict regulations. While ketamine has been used as an anaesthetic for decades, its use for mental health conditions, particularly treatment-resistant depression (TRD), has only recently gained formal approval and PBS subsidy. Consequently, understanding the legal pathways, prescribing requirements, and associated costs is essential for anyone exploring this treatment.
Legal Status: A Prescription-Only Medicine
Ketamine is a Schedule 8 (S8) controlled substance in Australia. This means it is a prescription-only medicine with strict legal controls due to its potential for abuse and dependence. It is legally available for specific medical purposes, but it is not a substance you can access over the counter.
Approved and Off-Label Uses
The legal framework distinguishes between TGA-approved indications and off-label use.
TGA-Approved Use: The Therapeutic Goods Administration (TGA) has approved esketamine nasal spray (Spravato) for the treatment of treatment-resistant depression (TRD) in adults. This is the only ketamine product formally approved for a mental health indication in Australia.
Off-Label Use: Generic ketamine (often administered intravenously) is TGA-approved only as an anaesthetic. However, medical practitioners can legally prescribe it “off-label” for depression or other conditions if they believe it is clinically appropriate. This practice is common but subject to strict state-based regulations.
How to Access Ketamine Therapy Legally
Access to ketamine therapy is not a simple matter of getting a prescription from a GP. It requires a structured, supervised clinical process.
Who Can Prescribe It
For treatment-resistant depression, only AHPRA-registered psychiatrists can prescribe esketamine or ketamine. Medical practitioners who are not psychiatrists must refer the patient to a psychiatrist for prescribing and supply.
State-Based Approval Requirements
State health departments impose additional requirements. For example, in New South Wales, psychiatrists must obtain an approval from the NSW Ministry of Health to prescribe esketamine or ketamine for TRD under certain circumstances, such as for a drug-dependent person or for continuous treatment exceeding two months. Applications are made via the SafeScript NSW portal.
Administration Under Medical Supervision
Esketamine and ketamine for depression must be administered under direct medical supervision in a healthcare setting. This setting must have established administration and patient monitoring procedures and be equipped to manage any behavioural or medical emergencies. Patients are typically monitored for two hours after each dose due to potential side effects like sedation, dissociation, and blood pressure changes.
Treatment Centres
Access is provided through specialised clinics or hospital services. For example, The Royal Prince Alfred Hospital (RPA) Ketamine Treatment Clinic was the first of its kind in the Australian public health system. Epworth Clinic has registered as an Esketamine Therapy Service and offers treatment in inpatient or outpatient settings.
The Cost of Ketamine Therapy
The financial cost of ketamine therapy varies significantly depending on the type of ketamine and the setting.
Esketamine (Spravato) : As of May 1, 2025, esketamine nasal spray is subsidised on the Pharmaceutical Benefits Scheme (PBS) for TRD. This reduces the cost of the medication itself to $31.60 per dose (or $7.70 for concession card holders). Before the PBS listing, a single dose could cost between $600 and $800.
The “Hidden” Costs: The PBS subsidy only covers the medication. The administration and supervision fees are not covered by Medicare or typically by private health insurance. These out-of-pocket costs can be substantial. For instance, Epworth Clinic charges a $340 procedure fee per session. Other reports indicate supervision costs can be $300-$400 per session.
Generic Ketamine (Off-Label) : Generic ketamine used off-label is much cheaper per dose, often costing $5 to $20. However, the associated clinical supervision fees would still apply, and this option is less likely to receive insurance or government subsidies for the procedure itself.
The Evidence and Ongoing Debate
The move to subsidise esketamine was based on clinical evidence showing its effectiveness for some people with TRD. Research, including a study led by UNSW Sydney and the Black Dog Institute, has also shown that low-cost generic ketamine is effective long-term for severe depression.
This has led to a significant debate in Australian psychiatry. Experts, including Professor Colleen Loo, point out that the low-cost generic option is not formally approved or subsidised, creating a situation where cost, rather than clinical judgment, can determine what treatment a patient receives. Professor Loo has argued that a Medicare item to cover the cost of the treatment procedure is needed to improve access.
Summary
In short, ketamine therapy is legal in Australia, but it is a highly regulated medical treatment. Access for depression is primarily through a psychiatrist, requires state-based approvals in some cases, and must be administered in a supervised clinical setting. While the medication cost for esketamine has become more affordable through the PBS, the significant out-of-pocket fees for the supervised treatment sessions remain a major barrier for many patients.