Over a year ago, the Australian Therapeutic Goods Association (TGA) made the surprise decision to legalise MDMA and psilocybin-assisted therapy for certain mental health conditions in February 2023. While the move was welcomed by some but not by others, real patient access has remained very low.
The move to prescribe MDMA and psilocybin-assisted treatment was made possible by the TGA re-scheduling these drugs from a Schedule 9 “prohibited substance” – with no recognised medical use – to a Schedule 8 “controlled drug” – enabling their use by specialised psychiatrists. Both substances can now be prescribed for post-traumatic stress disorder and treatment resistant depression.
While these changes were only implemented in July 2023, Freedom of Information (FOI) requests from TalkingDrugs reveal that, at the time of publishing, only nine prescribers were granted the right to prescribe MDMA and psilocybin.
Australia in the global context
While Australia’s move to re-schedule these substances was unprecedented, it builds upon growing global evidence of their efficacy for treating several mental health conditions. Their potential therapeutic benefits have long been supported by advocates and have been legitimised by the recent “psychedelic renaissance”.
With some nations (like Brazil) having long-standing religious exemptions for psilocybin’s use, and others having (like the American states of Oregon and Colorado) decriminalised their use, even fewer have attempted the medical use of MDMA.
Switzerland and Israel offer “compassionate” access to medical MDMA, bypassing their illegal status for use in extraordinary cases. The American Food and Drug Administration’s recent decision to reject the approval for MDMA-assisted therapy has made Australia’s move a true outlier in the medical regulation of previously illegal substances.
High Costs Limiting Access
The Australian re-scheduling of MDMA and psilocybin does facilitate access beyond its use as a “last-line” treatment. But other barriers remain in place that has kept treatment uptake low.
“A key barrier to access has been cost,” Professor Gill Bedi, an Australian researcher deeply involved in MDMA psychotherapy, told TalkingDrugs.
“These are very resource intensive treatments and because they are not covered under Medicare [the Australian universal healthcare system], the current costs are prohibitive for most people – perhaps particularly for people who have been living with chronic mental illness,” Dr Bedi added.
A psychedelic therapy program is a nine-month programme, with multiple trips conducted in the presence of licensed psychologists.
“The actual amount of money that people are paying is paying for the cycle for the therapy with the treatment process. There’s two therapists and they’re there for about 90 minutes for each session, and we’ve got 16 sessions in our treatment program.” Professor Suresh Sundram, director of Clarion Clinics, one of the few psychedelic assisted therapy clinics in Australia, informed TalkingDrugs.
Currently, MDMA and psilocybin treatment are estimated to cost more than $24,000 Australian dollars with a substantial portion going towards the therapy component itself. Given the long-acting nature of both substances, highly qualified staff needs to be working for prolonged periods of time. As each treatment cycle is composed of as least two dosage sessions, each exceeding eight hours, the costs start to add up.
To counter rising operating costs, research into shorter acting psychedelics, such as 5-MeO-DMT, has grown; but their clinical efficacy remains unproven. For the time being, it’s unlikely the cost of MDMA and psilocybin therapy will lower.
Although costs are expensive, in a country where almost 11% of the population (amounting to approximately 2.8 million people) will experience PTSD at some point in their lifetime, the potential need for these medications is clear.
All that said, the cost itself doesn’t serve to explain all the drivers limiting patient growth. For a complete picture, we have to look to at the TGA itself.
From prohibited to limited
While the cost of the therapies are a significant obstacle to access, TGA, the regulatory authority governing its use, is also limiting who can prescribe these novel medicines.
“The TGA did not appear to intend these treatments to be widely available, given that they do not yet have sufficient evidence to be fully approved,” Dr Bedi told TalkingDrugs, when asked about the barriers driving limiting the medications’ uptake.
Part of the reasoning behind this limited pool of prescribers stems from MDMA and psilocybin’s scheduling. As Schedule 8 substances, they have gone from fully prohibited to highly controlled; this scheduling shift means that medicines containing these substances can be accessed.
The process for access, however, is a lengthy one: for clinics to treat patients, they must apply to a human research ethics committee, providing details of clinical practices and therapy delivery. Upon approval, they must apply to the TGA for authorisation to dispense these medications; in some Australian states, this includes providing a record of treatment for each patient.
Access is further complicated as the TGA has not approved any medicine containing MDMA or psilocybin. The TGA’s Australian Register of Therapeutic Goods (ARTG) outlines all the drugs that are authorised in the country. No MDMA or psilocybin-containing products have yet been approved for safety and efficacy, although the TGA recognises their potential therapeutic value; this means they can still be supplied and administered as “unapproved” medicine by authorised prescribers.
The TGA is therefore in direct control of medicines access and the size of the authorised prescriber pool; and for the time being, they seem committed to keeping it small. John Skerritt, the former head of the TGA, confirmed in a past interview; he highlighted how the regulating authority was purposefully cautious in establishing access to MDMA and psilocybin.
“We could provide a second set of controls… to restrict [MDMA and psilocybin] to authorised prescribers. As soon as you do that, the use of it has to go through an ethics committee,” adding further control levers to approval processes, as Skerritt said in April 2023.
“I think it’s designed to be difficult [to access],” Professor Sundram confirmed to TalkingDrugs. “In essence to act as a break on anybody just sort of signing a form and submitting it [to get the medications].”
Along with these structural changes, there are more procedural components that must develop and mature, as with any new medicine appearing on a market. Interviewed experts highlighted there was a need for trained therapists to deliver the medicine. There is also no domestic manufacturing of medical-grade MDMA and psilocybin, meaning the medicine must be imported in an expensive, lengthy, and highly regulated process.
What is the future for these medicines in Australia?
High therapy costs and limited prescribers underscore how Australia seems to have kept MDMA and psilocybin access purposefully low: with only nine prescribers across a country of 26 million, the patient pool is set to grow by a handful a year – by design, rather than by fault.
As previously stated, the FDA rejection of MDMA has only supported the Australian case for expanding access conservatively.
“This [FDA’s rejection of MDMA] will push back the timeline of future TGA registration of MDMA for use in MDMA-assisted psychotherapy, as it seems unlikely that Australia would fully approve these medications for clinical use before the US and Europe.” Professor Bedi told TalkingDrugs.
While barriers driven by a delayed development of infrastructure may slowly diminish as the therapeutic system develops, the cost of the therapies themselves will remain a major limiting factor for the time being.
“I think more clinics will be set up over time, so we will see more authorised prescribers. We will see more people accessing the treatment, but it will primarily be either people who are very well off and able to afford it, or we see more health insurance providers come to the table and start funding access to the treatment.” Dr Stephen Bright, a psychologist and researcher, told TalkingDrugs.
The news of MDMA and psilocybin assisted therapy in Australia did come as a global surprise. But this rapid advancement has now been met with the reality of a regulatory system that prefers gradual progress over daring developments. With a heavy hand controlling prescribers and an eye-watering price (coupled with no insurance reimbursement – for now), access to these medicines is not likely to soar any time soon. While Australia may have been the first to legalise the medical use of MDMA and psilocybin, true widespread access may still be a long way off.
