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.’
CEO, Executive Lawyer, Patent & Trade Mark Attorney
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.
Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.