RE:RE:Revenue is on the way Key points about medicinal cannabis companies trying to enter Australia's new psychedelics market:
The Therapeutic Goods Administration (TGA) approved the use of MDMA for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression, effective from July 1.
Only TGA-authorized psychiatrists approved by a human research ethics committee can prescribe these medicines.
Eligible patients can access the medicines only in a supervised setting combined with psychotherapy.
The TGA's decision reflects the limited treatment options for specific mental illnesses and aims to protect vulnerable patients through highly controlled settings.
Several Australian medicinal cannabis companies are investing in the psychedelics market, aiming to provide these therapies.
Vitura Health, an ASX-listed company, is collaborating with Canadian drug manufacturer PharmAla Biotech Holdings to supply MDMA and psilocybin to Australia.
Reset Mind Sciences, a subsidiary of Little Green Pharma, is planning a clinical trial for psilocybin-based treatment and is partnering with a health insurer to establish a mental healthcare facility offering psychedelic-assisted therapies.
Incannex Healthcare Limited is planning to establish multiple psychedelic-assisted psychotherapy clinics in Australia, expecting the market to be worth over $2 billion annually.
The cost of treatment is estimated to be in the tens of thousands of dollars due to the lengthy treatment protocols involving psychotherapy and psychiatry.
Major health insurers in Australia are cautious about providing coverage for psychedelic treatments due to the emerging nature of the field and the need to monitor developments.
Advocacy group Mind Medicine Australia is working on plans to assist people who cannot afford the high costs of these treatments.
The TGA is collaborating with state and territory jurisdictions to implement the patient access framework for MDMA and psilocybin from July 1.
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) is establishing a steering group to provide clinical guidance on new psychedelics treatments.