In May 2023, Australia’s Therapeutic Goods Administration (TGA), the country’s FDA equivalent, moved to reschedule the use of psilocybin and MDMA for patients with treatment-resistant depression (TRD) and PTSD, respectively. That Summer, the downscheduling became a reality. Since then, certain psychiatrists (‘Authorised Prescribers’, in the country’s regulatory lingo) have been able to prescribe and administer psychedelic-assisted psychotherapy (PAP), without having to seek regulator sign-off for each and every patient, as is the case in some other systems.
Here, Monica Schweickle, founder of The Psychedelic Consultancy, an Australian firm that supports professionals navigating the country’s PAP system, and Psychedelic Alpha Editor Josh Hardman review the progress of the program and explore where it might be headed.
A Slow Start
Australia’s world-first psychedelics limited rescheduling didn’t open the floodgates when it was passed in the Summer of 2023.
Indeed, as Psychedelic Alpha reported last May, fewer than 100 patients accessed psychedelic-assisted therapy through the pathway in the first 18 months of its operation, according to data obtained via a Freedom of Information Request to the TGA. The majority of those were for MDMA (64), versus 32 for psilocybin. 35 Authorised Prescriber applications were approved in the same period, 18 for MDMA and 17 for psilocybin.
While uptake was clearly modest, it was increasing substantially every 6 months, Psychedelic Alpha noted. And advocates are keen to stress that a rapid rollout was not the goal of the program. Instead, they emphasise a much more ambitious attempt at integrating an intervention that remains experimental elsewhere in the world into routine psychiatric care.
2025 as a Turning Point
With the foundations in place, patient numbers began to grow in mid-2025 as the system found its footing. Since the first patients were treated under the Authorised Prescriber scheme in January 2024, 87 have been treated with MDMA-assisted therapy for PTSD and 47 with psilocybin-assisted therapy for treatment-resistant depression, as at 16 September 2025.
The number of psychiatrists who had become Authorised Prescribers of psychedelics could be counted in the dozens by mid-2025, too.
What changed? For one, referral pathways began to emerge, with general practitioners, psychiatrists, therapists and insurers all beginning to recognise PAP as a valid option for patients who have tried conventional treatments to no avail.
Some of that success, those on the ground believe, is rooted in the emerging safety profile of PAP in Australia. Focusing specifically on MDMA-assisted therapy, the international community has been watching closely to see the quantity and quality of serious adverse events recorded down under, as the drug is used alongside psychotherapy outside of the strict confines of controlled clinical trials.
The Authorised Prescriber scheme requires every prescriber, in this case psychiatrists, to report the number of patients treated and any serious adverse events (SAEs) that occurred to the Human Research Ethics Committee (HREC) that approved the protocol, the TGA, and the state’s health department.
Through a Freedom of Information request, The Psychedelic Consultancy obtained aggregated TGA data through September 2025, representing 87 unique patients receiving MDMA and 47 psilocybin. The data reports that zero SAEs were reported in the period across the cohort.
Outside of a reassuring lack of SAEs, albeit in a relatively small sample, the safety profile of PAP in Australia is beginning to clarify more generally. Other adverse events are being tracked by the Australian Interventional Pharmacotherapy and Psychedelic Assisted Psychotherapy Research Registry (AIPPAP-RR) hosted by the Australian National University, which also collects data on ketamine treatments. While it is not a TGA requirement for Authorised Prescribers to use the registry, the Department of Veterans’ Affairs recommends that prescribers use it, and ethics committees may look more favourably upon Authorised Prescriber applications that include the registry as an effort to measure safety and long-term outcomes. A study involving Medibank Private patients will use the Registry in 2026.
Early registry data reveal generally mild side effects, primarily appearing in the first and second dosing sessions. Withdrawals appear to be driven primarily by engagement barriers, rather than harms.
Outside of a lack of red flags in the safety domain, Australia’s PAP experiment is showing signs of early success in an access-related area: reimbursement.
As readers are aware, psychedelic therapies are very expensive, compared to the standard of care for mental health disorders, given the number of individuals involved in a patient’s care and the time spent per patient. This is especially the case in psychedelic-assisted psychotherapy, where mental health professionals like psychiatrists and psychologists are involved at each stage of the patient journey.
Even without a significant margin on the price of the MDMA itself, that resource intensity has driven average prices of around $30,000AUD for a three-dose MDMA-assisted therapy program, or $10,000AUD for one dose with accompanying preparation and integration sessions. That’s well beyond the reach of the average Australian. The main cost is psychiatrist and therapist time to deliver these therapies in a clinical setting, in line with standards in clinical trials that have demonstrated safety and efficacy for people with treatment-resistant PTSD and depression.
It’s not an Australia-specific issue, though: other countries and territories that have rolled out psychedelic access pathways that do not rely on traditional marketing authorisation have also struggled to solve the payor puzzle.
But both private and public payors in Australia made substantive moves to cover psychedelics in 2025.
Last summer, Medibank, Australia’s largest private health insurer, set aside AUD $10M for a pilot project in which it would fund access to PAPs. That started with MDMA in June and was expanded to include psilocybin later in the year.
Paired with a long-term outcomes and health economics study, it is clear that Medibank is looking to ascertain whether reimbursing PAPs makes sense. Its findings would provide a good indication of how other payors might view the intervention, at least in the context of Australia’s somewhat idiosyncratic approach to private health insurance.
Later in the year, the Australian Department of Veterans’ Affairs committed to funding PAP for eligible veterans, in another world first.
Perhaps reassured by a lack of a ‘wild west’ scenario, an emerging safety profile, and payor interest, the number of Authorised Prescribers ticked up throughout 2025. By year-end, 30 psychiatrists were authorised to prescribe MDMA and 26 authorised to prescribe psilocybin (some of these numbers reflect psychiatrists who can prescribe both medicines). Schweickle, a Clinical Psychologist and co-author of this article, has personally supported over half of these psychiatrists through protocol development and therapeutic program design, to undergo the administrative and regulatory requirements of Authorised Prescriber applications.
More than 600 therapists, meanwhile, have completed recognised training programs. MDMA and psilocybin-assisted therapy is now available in six of Australia’s eight states and territories, including regional areas.
Lastly, it’s not just Aussies who are accessing MDMA. A surprising signal reveals that some patients have travelled internationally to receive the intervention in Australia, though it is likely only a handful of individuals at present.
Looking Ahead to 2026
Could Australia, with a population of fewer than 30 million people, realistically become the first country to treat 1,000 patients with MDMA-assisted psychotherapy in a single year, as early as 2026?
If the system is to move from treating hundreds of patients to more than a thousand a year, several changes must occur.
Firstly, the workforce would need to develop, as it remains a primary bottleneck today. To treat 1,000 patients a year, more than 100 Authorised Prescriber psychiatrists would likely be necessary, along with a therapist workforce in the low thousands and the involvement of larger providers alongside a healthy ecosystem of independent and culturally responsive clinics.
Some, including co-author Schweickle, have called for the inclusion of Indigenous therapists, for example, under the recognised therapist roles. Indigenous Psychedelic Assisted Therapies (IPAT), an Australian organisation that advocates for Indigenous representation and inclusion in the emerging field of psychedelic-assisted therapy, advised that they have trained over 100 Australian therapists. IPAT hopes that in 2026, cultural training for PAT will be embedded into all practitioner training, rather than an optional add-on, with all therapists working in PAT undertaking this cultural training.
Should the Authorised Prescriber scheme remain restricted to psychiatrists, their role will increasingly involve managing prescribing and oversight of sessions, as opposed to directly delivering therapy.
In order to reach a larger number of patients, authorised prescriber protocol reviews will be essential, particularly around patient eligibility criteria and treatment models. Conservative safety thresholds should be maintained as this proceeds.
While the Authorised Prescriber scheme is currently restricted to PTSD and TRD, reflecting the evidence base used by TGA to establish safety and efficacy, this could change as more late-stage studies are published. Should that data be deemed compelling, it could support protocol amendments through Human Research Ethics Committees and expand access to new patient populations or protocols under the existing framework. There is currently a TGA submission underway to include end of life distress as a population eligible for access to psilocybin-assisted psychotherapy. Other emerging evidence could include, for example, group dosing studies and research into other mental health conditions.
We will also be watching closely how the nascent public and private funding mechanisms for PAPs in Australia develop, and whether new payors enter the fray.
Australia’s program has got ahead of international approvals of psilocybin and MDMA, but one day we could see TGA bring the drugs onto its list of approved therapeutic goods, given both drugs are expected to secure FDA approvals, for example.
What that might mean for Australia’s Authorised Prescriber program remains unclear. Some believe it could expand access, while others are concerned that FDA-approved psychedelics have detached the psychotherapeutic element, which is central to Australia’s program.
Monica Schweickle is the co-founder and director of The Psychedelic Consultancy, which guides health professionals and organisations through the PAP landscape in Australia. She is also a Clinical Psychologist and Co-CEO of The Peridot Clinic.
