A decision on whether to subsidise a CBD medicine that fights severe epilepsy in children has been deferred despite health professionals accepting cannabidiol is “likely to be beneficial”.
The Pharmaceutical Benefits Advisory Committee (PBAC) said it was delaying a verdict on Epidyolex to enable further consultations to take place.
Epidyolex, manufactured by UK-based GW Pharmaceuticals in collaboration with Chiesi Australia, treats Lennox-Gastaut and Dravet syndromes (LGS and DS), both intractable types of epilepsy which develop at a young age.
The application for PBS listing was for an oral solution for patients aged two years old and above with a strength of 100 mg per ml, 100 ml.
On its website, the PBAC said: “The PBAC deferred making a recommendation for the listing of cannabidiol for the treatment of DS and LGS in combination with other anti-epileptic drugs on the PBS to enable consultation with stakeholders regarding the role of cannabidiol in the treatment of these rare forms of epilepsy.
“The PBAC considered further clarity on the clinical place of cannabidiol in therapy is required to inform the appropriate initial and continuing restriction criteria, cost-effectiveness and financial implications of listing cannabidiol.
“The PBAC considered there was a clinical need for additional effective and safe treatment options for people with DS and LGS and the clinical evidence presented in the submission demonstrated cannabidiol is likely to be beneficial; however, the magnitude of the benefit was uncertain.”
The deferral will disappoint the sponsor of the application, Chiesi Australia, formerly Emerge Health, and parents who have children battling DS or LGS.
Chiesi Australia said: “We will work collaboratively with the PBAC, the Department of Health, and the Federal Government to ensure patients living with DS and LGS receive access to Epidyolex through the PBS at the earliest opportunity”.
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 deferral means there is still no subsidised medicinal cannabis drug in Australia.
Sativex, a CBD medicine administered in the treatment of moderate-to-severe spasticity in MS patients, was knocked back by the PBAC in March.
Sativex is the only medicinal cannabis product included in the Australian Register of Therapeutic Goods (ARTG).