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.
“Other steps generally need to be taken before a listing is achieved such as pricing negotiations with the sponsor, finalisation of the conditions for listing, availability checks and consideration and approval by the Government,” the spokesperson told Cannabiz.
In its submission to the Senate inquiry earlier this year which explored the barriers to accessing medicinal cannabis, the department said it was the Government’s “ultimate goal to have a wider range of medicinal cannabis products included in the ARTG as regular medicines”.
The sponsor of the Epidyolex PBS application, Emerge Health, was also behind the failed bid to get Sativex listed as a government-subsidised medicine in March.
Sativex, the trade name for nabiximols, a CBD medicine administered in the treatment of moderate-to-severe spasticity in MS patients, is currently the only medicinal cannabis product included in the ARTG, having been registered in 2012.
But the PBAC remained unconvinced about its inclusion as a subsidised medicine.
“The PBAC considered the clinical claim that adding nabiximols to standard care was more effective than standard care alone was reasonable, however, considered the magnitude of benefit was uncertain and likely to be modest,” a DoH spokesperson said. “The PBAC also considered the economic modelling presented in the submission was unreliable.”
Emerge Health said it was “disappointed with the decision” but added it would “continue to work collaboratively with the PBAC, Department of Health and Federal Government to ensure patients with MS-related spasticity receive access to Sativex through the PBS”.