We previously reported in our article “Developments in Australian CBD market” that the Pharmaceutical Benefits Advisory Committee (PBAC) was considering at its meeting in July a submission by Emerge Health Pty Ltd (now, Chiesi Australia Pty Ltd) to have Epidyolex, which contains cannabidiol (CBD) as its active ingredient, subsidised by the Australian Government through listing on the Pharmaceutical Benefits Scheme (PBS). If successfully listed on the PBS, it would be the first CBD medicine to be supplied in Australia and reimbursed by the Australian Government.
On Friday, 21 August 2020, the PBAC published the outcomes of its meeting held in July.
The PBAC decided neither to recommend, nor to not recommend, the listing of Epidyolex on the PBS. Rather, the PBAC deferred making any recommendation for the listing on the PBS of CBD for the treatment of Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in combination other anti-epileptic drugs to a later, currently undetermined date. According to the PBAC, this is so that consultation with stakeholders regarding the role of CBD in the treatment of the rare forms of epilepsy may be undertaken.
The PBAC recognised that there is a clinical need for additional effective and safe treatment options for people with DS and LGS. However, despite this and the clinical evidence presented for Epidyolex which the PBAC noted demonstrated that treatment with CBD “is likely to be beneficial”, the PBAC was uncertain about the magnitude of the benefit of treatment with CBD. The PBAC noted that further clarity on the clinical place of CBD in therapy was required which would also inform the PBAC about appropriate patient eligibility criteria, its cost effectiveness, and the financial implications to the Australian Government of listing it on the PBS.
Whether Epidyolex will be ultimately be listed on the PBS for reimbursement by the Australian Government remains to be seen. However, in any event, Epidyolex must first obtain market authorisation in Australia, through registration on the Australian Register of Therapeutic Goods (ARTG), which as of the date of this article, is still pending.