MELBOURNE: Patient access to psychedelic-led therapy is expected to increase – and be cheaper – after the drug regulator recommended a rapid expansion of the medical practitioners who can conduct the controversial therapy sessions.
Australia became the first country in the world to allow the use of MDMA in therapy for PTSD and psilocybin therapy for treatment-resistant depression.
The shock decision in 2023 was made despite the drugs being “unapproved therapeutic goods”, meaning they are not assessed for safety, quality, or effectiveness.
This week, the Therapeutic Goods Administration updated details of the Authorised Prescriber Scheme for the drug therapies after holding a series of consultation.
The result is significant changes to who can conduct the controversial therapy sessions.
The psychedelic drugs can only be used in combination with intensive psychotherapy and only specially trained and approved psychiatrists can prescribe and administer the medications.
Once a patient takes the drug, two therapists then conduct the hours-long sessions. Typically, this team has been made up of a psychologist and a counsellor.
Now, the TGA says that team can be expanded, so long as the medical practitioner meets certain registrations and is appropriately trained in psychedelics.
“The psychedelic‑assisted psychotherapy dyad (team) must include at least one therapist who holds the following registration with one of the following national boards: psychology board with endorsement as a clinical psychologist, medical board with general registration, nursing and midwifery board with mental health experience, occupational therapy board,” the TGA notice states.
The prescribing psychiatrist is able to determine the rest of the makeup of a therapy team, with a significantly expanded scope of who could be considered.
“This includes assessing both the national board‑registered practitioner and any additional practitioners, such as psychotherapists, counsellors, social workers, or Aboriginal and Torres Strait Islander health workers,” the TGA notice states.
Another change is around the oversight of the prescribing psychiatrist, also known as an authorised prescriber or AP.
At present, an AP has to remain on-site at the clinic until the patient’s full therapy session is complete. Sessions last the duration of a patient’s trip, which can be around eight hours.
Now, the TGA’s recommendation says the prescriber can leave the clinic once the drug is ingested, so long as a patient remains within 15 minutes of an emergency room. However, the prescriber remains responsible for the patient and the therapy team even if they have gone off-site.
In addition, the AP is responsible for ensuring treatments are conducted in a clinical setting.
Psychiatrists wanting to become an AP must show they have experience in psychedelic-led therapy through involvement in clinical trials or that they have received supervision in psychedelic-assisted psychotherapy from an experienced AP.
The TGA told The Australian its recommendations “are now in place”.
The changes are likely to attract criticism by doctors groups, including some psychiatrists, who worry access to the experimental drugs is already too loose. One concern is that there is far too little evidence the therapies are effective yet they come with a huge price tag of around $30,000 and are targeted at vulnerable patients.
There are concerns too about possible side-effects, including psychosis, for patients.
Advocates argue the therapies are proving to be useful to a range of patients who have not responded to traditional interventions and that the drugs provide practitioners with more treatment options.
Regulators are also considering whether to expand access to psilocybin-led therapy to people in end of life distress.
Monica Schweickle is a clinical psychologist and director of the Peridot Clinic and psychedelic consultancy and welcomes the changes.
“This will hopefully mean that the costs will come down if there’s less hours of psychiatry time and if there is more scope to use differently trained mental health professionals that may also reduce the cost,” she said.
“Authorised prescribers that are brave enough to do this work because they want to find new options for their patients are already so cautious because these are unapproved therapeutic goods.
“So I’m not sure how many of them would want to leave the site. But potentially, if you have a patient who has maybe done a number of dosing sessions already and they’ve been well screened, they’ve got a really good therapist team, then that would be a possibility to reduce the cost to someone.”
She particularly hopes it means more patients in regional and rural areas will be able to access the therapies.
“It will hopefully reduce some of the costs and expand access in rural and regional areas,” she said. “That’s one of the points the TGA has made; wanting to ensure cultural safety as well and that an Indigenous therapist in remote parts of the country can be involved in this work so there is more choice.”