Generally, medicines prescribed in Australia must be assessed by the Australian Government’s Therapeutic Goods Administration (TGA) for quality, safety and efficacy, and registered on the Australian Register of Therapeutic Goods (ARTG). They must be legally produced, meaning the product will be either supplied by wholesale and/or imported from a legal supply source overseas according to the Customs (Prohibited Imports) Regulations 1956, or lawfully produced and manufactured in Australia under the Narcotic Drugs Act 1967 (Cth).
Formally registered cannabis medicines
Four cannabis medicines have been formally assessed for quality, safety and efficacy, either in Australia or by an overseas medicines regulator.
In Australia, the TGA has registered the following medicines on the ARTG:
- Sativex® (nabiximols) for treatment of moderate to severe spasticity associated with multiple sclerosis.
- Epidyolex® (cannabidiol) for management of Dravet and Lennox-Gastaut syndromes.
In the United States, the Food and Drug Administration (FDA) has approved:
- Marinol® and Syndros (dronabinol) for the treatment of anorexia associated with weight loss in patients with AIDS and management of chemotherapy-induced nausea and vomiting where standard anti-nausea treatments have failed.
- Cesamet® (nabilone) for management of chemotherapy-induced nausea and vomiting.
- Epidiolex (cannabidiol) for management of Dravet and Lennox-Gastaut syndromes and tuberous sclerosis complex.
If doctors wish to prescribe a cannabis medicine which has not been registered in Australia to their patient, they must seek authority from the TGA. NSW Health authority is also required to prescribe an unregistered Schedule 8 cannabis medicine to a patient who is drug dependent or a child under 16 years. Patients should discuss the potential pathways for accessing cannabis medicines with their treating doctor.
Cost of medicines
The cost of cannabis medicines may vary depending on a range of factors, including the specific product, the dosage required and whether the product is imported.
As suppliers and pharmacies determine the cost of cannabis medicines, you should speak to your local pharmacist as they will be best placed to advise you about the cost of a specific cannabis medicine.
The Australian Government administers the Pharmaceutical Benefits Scheme (PBS) and currently only one cannabis medicine, Epidyolex®, is listed on the PBS for treatment of seizures associated with Dravet Syndrome for patients two years of age and older.
A product must be registered on the Australian Register of Therapeutic Goods (ARTG) before a company can apply for it to be subsidised under the PBS. When an application is made, the Pharmaceutical Benefits Advisory Committee (PBAC) assesses the safety, efficacy and cost-effectiveness of the product to determine whether it should be subsidised. Although Sativex® is registered on the ARTG, it is not subsidised under the PBS.
All other cannabis medicines are not on the Pharmaceutical Benefits Scheme so patients need to pay the costs of purchasing the product. There are no other subsidies available for cannabis medicines.
If eligible, participating in a clinical trial is a pathway to access cannabis medicines at no cost to the participant. Please speak to your treating doctor about participating in a clinical trial.