Epidyolex recommended for PBS listing

In September 2022, the Pharmaceutical Benefits Advisory Committee recommended to list cannabis medicine Epidyolex® on the Pharmaceutical Benefits Scheme (PBS) for Lennox-Gastaut Syndrome. 

The manufacturer will now work with the Australian Department of Health to finalise the listing arrangements before Epidyolex® is available as a PBS product for patients with Lennox-Gastaut Syndrome. Epidyolex® is already listed on the PBS for Dravet Syndrome. 

Epidyolex® is a cannabidiol only product developed by United Kingdom based company GW Pharmaceuticals. It has been approved by the TGA for treatment of seizures associated with Lennox-Gastaut syndrome or Dravet Syndrome for patients two years of age and older.  

NSW Government funded research on the use of Epidyolex® for the treatment of paediatric epilepsy provided evidence to support the product being registered. Further details about these trials can be found on the Clinical Trials section of this website. 

As registration on the ARTG is a pre-requisite for Australian Government funding through the Pharmaceutical Benefits Scheme, this may eventually lead to reduced out of pocket costs for patients. 

Epidyolex® is the first cannabidiol only cannabis medicine to be registered on the ARTG. The only other cannabis medicine registered in Australia is Sativex®, which is the medicine nabiximols which is a mix of various cannabinoids, approved for treatment of spasticity associated with multiple sclerosis.  

Further information about the TGA’s decision to register Epidyolex® can be found on the TGA’s website