Australians are expected to pay out-of-pocket costs of at least $25,000 to receive MDMA and psilocybin therapy when the psychedelic drugs become classified as medicines to treat certain mental health conditions later this year.
The Therapeutic Goods Administration (TGA) shocked researchers last month when it announced that authorised psychiatrists would be able to prescribe MDMA to assist treatment of post-traumatic stress disorder, and psilocybin, the active ingredient in magic mushrooms, for treatment-resistant depression from July 1. They will still be considered prohibited substances – or schedule 9 drugs – for all other uses.
But the TGA has not approved any products containing psilocybin or MDMA for use in Australia, meaning the psychiatrists will have to source and supply unapproved medicines themselves.
The training regime to determine who becomes an authorised prescriber is still up in the air, and there are no detailed guidelines for how the treatment must be performed, as the TGA will leave that decision up to ethics committees.
Without any form of government subsidy for the drugs or associated treatment, researchers in psychedelic-assisted therapy say it is likely to cost between $25,000 and $35,000 when it is rolled out in a limited capacity later this year.
The drugs themselves cost between $1000 and $2000 for a standard course of treatment, according to researchers, although that could change when they are supplied commercially rather than for research. But the level of supervision and the multidisciplinary teams required to administer the full treatment will raise the bill.
Most clinical trials require two psychologists to supervise at least three eight-hour sessions when the drugs are administered, with additional therapy sessions in between. Prescribing psychiatrists and physicians are also employed to conduct medical assessments and screening.
In most clinical trials, this costs at least $20,000, even before the additional operating costs of a private clinic and profit are factored in.
“For the actual patient, it might be $25,000, $30,000 for a treatment,” said Dr Stephen Bright, a senior lecturer at Edith Cowan University and director of the charity Psychedelic Research In Science & Medicine.
“I honestly don’t think, for the next 12 to 18 months post July 1, that these treatments will be very widely available at all. The tight controls of therapy mean there are very few psychologists who put their hand up. There will be a few clinics that open up, but I don’t think we’re going to see the floodgates open.”
Dr Paul Liknaitzky, head of the Clinical Psychedelic Lab at Monash University, announced last week he and other experts would partner with a capital investment company to open a mental healthcare clinic in Melbourne later this year, with a focus on psychedelic-assisted therapy.
Liknaitzky said his team wanted to help set high standards as the Australian medical community navigated a new space.
“There is a lack of detailed clarity from the TGA to help us understand how it’s going to roll out. We are concerned but cautiously optimistic,” he said.
He also expects treatment to be initially out of reach for many Australians.
‘It’s going to be for people with money, in the initial stages at least.’
Senior researcher Gillinder Bedi
“Sensible and safe treatment approaches, based on decades of best-practice development, will include considerable screening, psychotherapy and other support. A typical course of treatment, spanning a few months, may be in the order of $25,000, plus or minus $10,000,” he said.
“If it turns out to be cost-effective, it will be in the government’s interest to fund it.”
Liknaitzky said he was seeking to work with private insurance companies and relevant organisations to subsidise treatments in the short term, while the long-term goal would be working towards a subsidy through Medicare. His clinic will run a health economics unit to examine the cost-effectiveness of the program.
Professor Chris Langmead, from the Monash Institute of Pharmaceutical Sciences, said it was hard to see how the treatment would be available through the public system until that type of analysis was available.
“We’re trying to get a groundswell of research and funding so we can do the research, clinical studies and practice rollout [to ensure] that this is not purely a market-led solution where the most disadvantaged populations are missing out,” he said.
Langmead said developing a sovereign manufacturing process for these substances would be crucial, so import requirements did not slow down progress.
“The TGA has put Australia at the forefront of the world and we really need to take the opportunity and make the most of it,” he said.
University of Melbourne associate professor Gillinder Bedi said the stretched psychologist workforce would be another barrier.
“The infrastructure will get set up. There will be clinics. But the problem is we don’t have staff. People can’t even see psychiatrists under normal conditions,” she said.
“If you put two clinical psychologists in a room for eight hours, at a [Medicare] billing rate of $120 an hour – which is not what people charge, they charge $200 to $300 – you have an enormously expensive treatment. I think it could get higher [than $25,000].
“No matter which way you look at it, it will take time away from other treatments and cost a whole bunch of money. It’s unclear who will foot the bill, some organisations are trying to set up philanthropic funding. But it’s going to be for people with money, in the initial stages at least.”
The Royal Australian and New Zealand College of Psychiatrists is establishing a steering group of experts to develop guidance and resources for psychiatrists who want to work in psychedelic therapies.
“To continue to grow the evidence base, there should be systematic and standardised data collection on efficacy and safety outcomes via a clinical registry,” college president Vinay Lakra said.
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