Australia’s Minister for Health and Aged Care, Mark Butler, has commented on issues regarding medical cannabis and the country’s Pharmaceutical Benefits Scheme (PBS).
The PBS began as a limited scheme in 1948, with free medicines for pensioners and a list of 139 ‘life-saving and disease preventing’ medicines supplied free to other members of the community. As at July 2022, there were 925 different medicines subsidised by the Australian Government listed on the PBS. Only one cannabis medicine is among them.
Responding to a petition concerning medicinal cannabis cost issues, Minister Butler said he was aware many Australians were experiencing difficulties.
Medicinal cannabis products are regulated medicines in Australia, but only two have been approved by the Therapeutic Goods Administration (TGA). One is Epidyolex; a cannabidiol (CBD) based product registered by the TGA for seizures associated with Lennox Gastaut syndrome or Dravet syndrome. It is PBS listed for these indications.
The other is Sativex (nabiximols) which contains delta-9-tetrahydrocannabinol (THC) and cannabidiol. This is registered by the TGA for moderate to severe spasticity due to multiple sclerosis but is currently not listed on the PBS. Sativex was considered for PBS listing on a couple of occasions – most recently in 2020 – but didn’t make the cut due to limited evidence to demonstrate clinical efficacy and safety compared with standard treatment.
“Medicines are not generally made available on the PBS to treat conditions for which they have not been approved for use in Australia by the Therapeutic Goods Administration (TGA),” said the Minister. “This is important because the PBS listing process relies in part on the assessment of quality, safety and efficacy that serves as the basis for TGA registration.”
There are provisions such as the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme that allow doctors and patients to access ‘unapproved’ treatments such as medicinal cannabis. But Minister Butler pointed out the Government has no control over the price a supplier charges for these ‘unapproved’ medicines. However, he mentioned some companies offer reduced costs through their own compassionate access programs.
“Individuals or their prescribing health practitioner may wish to contact the relevant company to enquire about the availability of such access programs,” he wrote.
The full response from Minister Butler can be found here.
