A CBD medicine that fights severe epilepsy in children could become the first medicinal cannabis drug available through the Pharmaceutical Benefits Scheme (PBS).
The Pharmaceutical Benefits Advisory Committee (PBAC) will discuss the application for Epidyolex this month with a decision made public on the PBS website around six weeks later.
Epidyolex, manufactured by UK-based GW Pharmaceuticals in collaboration with Emerge Health in Australia, treats Lennox-Gastaut and Dravet syndromes, both intractable types of epilepsy which develop at a young age.
If approved, it would mark a milestone for the industry in becoming the first medicinal cannabis product to be subsidised through the Government scheme. More pertinently, a positive ruling would bring the drugs within financial reach of many families struggling with the costs of accessing Epidyolex through the current pathways for unapproved drugs.
Under the PBS, patients pay up to $41 for medication. Currently, Epidyolex can cost families many thousands of dollars.
Late last year, Epidyolex was granted orphan drug status by the TGA, a designation which waives the application and evaluation fees for ARTG registration. It was also given a priority review determination which enables an “expedited assessment”.
The Department of Health stressed the special conditions granted to Epidyolex did not mean ARTG registration was guaranteed.
Health officials also warned that while a recommendation from the PBAC was an important step in obtaining a PBS listing, it was not the only one.