After Mind Medicine’s very successful International Summit on Psychedelic Therapies for Mental Illness, I’m sure the nascent industry is ablaze with ideas and inspiration.
The down-scheduling decision on MDMA and psilocybin is due to be released in Dec 2021, and one of the last things we were asked to do as participants of the summit was to band together and think about the next steps in making psychedelic therapies a reality in Australia. In this regard, a lot of the way has already been paved during the rise of the medicinal cannabis industry, and there are some key learnings that can be leveraged off their existing pathways and practices.
Personally, I like to focus on practical implementation from a compliance perspective. While there were a lot of speakers at the summit to draw inspiration from, I’m going to use this blog to brainstorm ideas to address the 5 main barriers to accessing new therapies (mentioned by Dr Lynn-Marie Morski during her talk on “Integrating psychedelic therapies into the current medical model”).
Before we start, I must declare two assumptions that I have made:
- Initially, prescriptions for Psychedelic-Assisted Therapy (PAT) will proceed under Special Access Scheme B (SAS B), Authorised Prescriber Scemes (AP), and Clinical Trails (CTX/CTN) before any products are approved and registered on the ARTG in Australia.
- Because PAT requires administration of the psychedelic in a controlled setting, patients will not be able to fill a script at a pharmacy and self-medicate at home, therefore it is likely that PAT-specialist clinics will have to be set up and registered (much like methadone clinics – the similarity to the PAT model I’ve outlined in a previous blog).
With that out of the way, let’s begin!
The 5 Main Barriers
Unless patients have been watching the psychedelic space, they will not be aware of what their options are, or even how to access psychedelics to treat mental health ailments. There may also be an unwillingness to participate in the new therapy given all the bad press in the past. In terms of improving public information, the TGA could develop a psychedelics therapies information portal, similar to medicinal cannabis, that includes topics relevant to clinicians, product sponsors, and patients.
Patients should be able to go to their medical practitioner and, if assessed as suitable (i.e. no contraindications in their medical history), their prescriber may make an application for them via SAS B, obtain HREC approval/specialist college endorsement, and refer them on to a registered PAT clinic.
It would be practical to develop a psychedelic information and access portal (similar to the way Althea Concierge has functioned for medicinal cannabis). This would assist:
- patients finding doctors who are familiar with PAT
- doctors accessing sponsors/suppliers of psychedelic drugs
- doctors accessing/referring patients on to PAT-registered treatment clinic.
- Medical Practitioners (MPs)
If MPs have not been keeping up to date with the research and news, they will be in a similar situation to patients. If MPs do not know how to prescribe psychedelics and for what ailment, they will be unwilling to take on the liability of making a SAS B application to prescribe an unknown and unapproved medicine. While the list of who can qualify as a MP is fairly broad on AHPRA, each Australian state and territory will have nuances in their laws regarding which health professionals can write a prescription, and which medicines they can prescribe in what circumstances.
To alleviate concerns related to use of a new medicine, clinical guidelines should be developed in a similar format to methadone, or cannabis. Because the field is constantly being updated, the industry may benefit from this guideline being a live web page as opposed to an issued guidance document. Whether guidelines are developed for each psychedelic, or one guideline is developed for all psychedelics (following the same PAT model but with differences in dosing, etc.) that will remain up to the regulator to decide.
To make things easier in terms of on-boarding new drugs into S8, it would be worth focusing energy on only a few key psychedelics initially. During a panel discussion at the summit, Adj. Professor John Skerritt speculated that MDMA and Psilocybin were the most likely to “go live” first, however he made it clear that the final decision on the down-scheduling review was out of his hands.
Currently, psychedelics (known more formally as psychotropics in the regulations) are still in the S9 Prohibited Poisons category which places restrictions on how they can be used (i.e. limited to research and some clinical trials). However, state and territory legislation can differ – for example, regulations in VIC and NT do not allow S9 substances to be used in clinical trials.
Even if psychedelics were down-scheduled to S8 Controlled Drugs, until products go through the ARTG registration process they would be considered as unapproved medicines and come with limitations on advertising, as well as limitations on prescription and treatment services.
As the current regulations stand, to obtain or produce psychotropic drugs you would either have to:
a) apply for an ODC import licence for a psychotropic drug, or
b) apply for a State/Territory licence to manufacture/produce a S9 Poison (usually under the Department of Health).
It should be noted however, in both scenarios you would likely have to provide evidence of your supply chain, as well as evidence of the clinical trial being supplied.
A huge gap that currently exists is that there is no legal framework for how the PAT model would be applied. I have assumed that it will likely follow the methadone model purely due to the similarity in administration, but the final decision will be up to the regulator and they will undoubtedly have different ideas. A lot of issues need to be ironed out, e.g. will registered PAT clinics even be the approved model, will this registration be controlled by state/territory legislation as with methadone clinics, do prescribers have to be a part of these clinics and supervise their patients directly or can prescribers refer patients on to a PAT clinic, etc.
Additionally, it is a huge unknown at this stage as to whether the ODC or TGA are going to take on the responsibility of designing and administering the regulatory framework required for PAT (including licences for local cultivation and production, or whether it is going to be left up to the state/territory departments to roll out.
If current regulator trends are to be followed (and psychedelics are down-scheduled) it is likely that:
- the ODC will be in charge of local psychotropic production/manufacturing licences
- the TGA will be in charge of GMP manufacturing and product registration
- the state/territory health departments will be in charge of the S8 licencing and PAT clinic registration.
Either way, the ODC will need more resources – right now they are working on streamlining the medicinal cannabis framework under the “Single licence model” (which local production of psychotropics could potentially follow, but that’s the subject for another blog!).
The TGA has also scheduled additional reforms for medicinal cannabis that potentially could be applied to future incoming unapproved psychotropics drugs, namely:
- the requirement to adhere to local packaging and labelling requirements (currently, unapproved medicines are excluded).
- the requirement for imported products to provide evidence of being manufactured under GMP.
Given PAT requires supervision by two therapists for 7-8 hrs per session, it is easy to see how costs to patient can rack up quickly. If psychedelics proceed via SAS or AP schemes, then the unapproved therapeutic goods will not be subsidised under the Pharmaceutical Benefits Scheme (PBS).
However, there are a few things that may alleviate this:
- 81% of Australian health funds cover medicinal cannabis prescribed under SAS or AP (under Extras non-PBS pharmacy/pharmaceuticals), which could potentially be used to cover some of the cost of the psychedelic drug.
- Psychological service subsidies exist if you have been diagnosed with a mental disorder, or have been approved to go on a mental health treatment plan. Patients could be entitled to Medicare rebates for up to 20 individual psychological appointments per calendar year, and if the rebate is applicable to the PAT practitioner, could help fund the sessions.
As mentioned by Rick Doblin during the summit, additional inputs could also come from both government and pharma. Governments may want to incentivise pharmaceutical companies to develop drugs on a data exclusivity vs patent model (i.e where there are benefits for prescribing drugs off-patent). Burgeoning psychedelic pharma companies could consider developing a patient-first model vs for-profit model which would keep costs of the drugs in check. (Patient-first models may lower the valuation of a company initially, but a lot of things need be done to bolster the industry that are non-monetisable!).
It would also be useful to do a cost-benefit analysis of the potential of PAT therapies vs traditional therapies in Australia (MAPS did one for MDMA vs PTSD), which could be used to encourage the government to offer additional subsidies or financial assistance in the future!
- Referral/ certification
Psychedelics and the PAT model has an advantage over medicinal cannabis in that they can be used in conjunction with already familiar and accepted psychological therapies (e.g. talk therapy). Currently, the only PAT training program in Australia is not officially recognized. If Mind Medicine became a Registered Training Organisation, this would greatly boost formal acceptance of the certificate and provide greater confidence to therapists and medical practitioners.
In the early days (and to reduce some of the perceived risk) it might also be beneficial to conduct supplemental refresher training (e.g. annually to ensure that practitioner knowledge remains up to date), and set up industry body to provide peer-to-peer support and practice groups.
So, what next?
First and foremost, there needs to be a pre-emptive industry consultation. The regulator needs guidance on what these therapies are, how they are applied, and ideas on the most practical way to roll this out. Governments tend to be extremely risk-averse, and the more risks are identified and addressed in advance, the more amenable to change they will be.
As an aside, the model for psychedelic therapies appears to have a wide application that would be constricted by the limitations imposed after product registration. This is not to say that product registration is not a valid, nor useful pathway to go down, but the approved clinical use would be locked at: PAT+[psychedelic]+[ailment]. It may actually be beneficial to keep a degree of PAT operating under SAS B/AP and controlled under the discretion of the prescriber to allow it to have the maximum therapeutic benefit for as many people as possible.
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