• Naomi Pearce & Emily Bristow

PBAC defers decision on PBS listing of Chiesi's unregistered medicinal cannabis product Epidyole


On 21 August 2020, PBAC published the results of the July meeting at which PBAC deferred its decision regarding Chiesi's application to list Epidyolex® (cannabidiol). The PBAC deferral was to enable consultation with stakeholders. PBAC suggested '..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 [PBS] listing cannabidiol'.

Chiesi had sought recommendation for PBS listing Epidyolex® for the treatment of Lennox-Gastaut and Dravet Syndromes (a subset of paediatric epilepsy). This is the first request for PBS reimbursement for an unregistered medicinal cannabis product in Australia. Whilst the product is not registered as a medicine, it is supplied to patients through the Special Access Scheme (SAS), under which prescribers can apply to the TGA for access to medicinal marijuana on a case-by-case basis. Currently, patients accessing medical marijuana must cover the full cost themselves, a fact which the February 2020 Senate Inquiry noted was a significant barrier to access to medical marijuana in Australia.

The PBAC minutes note that Chiesi responded to the deferral outcome, stating that it '..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.'

Biosimilars Bulletin 
Search by tags

© 2019 Pearce IP | Australia

  • LinkedIn Social Icon