Cannabidiol PBS listing expanded: Chiesi secures second PBS reimbursed indication for Epidyolex®

by , , | Jun 26, 2023

Cannabidiol Medicine

The PBS listing for Chiesi’s Epidyolex®, an oral cannabidiol, was expanded on 1 June 2023 to include treatment of seizures in patients with Lennoz-Gastatut Syndrome (LGS).

Epidyolex® was one of the first cannabis-based drugs approved in Australia back in May 2021 (second only to Sativex®, which was added to the ARTG in 2012) and is the only PBS-listed medicinal cannabis product. The original PBS listing for Epidyolex® included reimbursement when used to treat Drevet Syndrome, a rare and drug-resistant form of epilepsy that presents in infancy.

In March 2022, Chiesi failed to obtain PBS listing for Epidyolex® for the LGS indication.  Although the PBAC considered cannabidiol to be effective in treating seizures associated with LGS, it was concerned by the unacceptably high price Chiesi would charge the Department of Health for Epidyolex®.  The PBAC also advised that cannabidiol was inferior to the standard of care in terms of safety.

At the September 2022 PBAC Intracycle Meeting, following resubmission, PBAC recommended the PBS listing for Epidyolex® be updated.  The Committee recommended it be listed to treat seizures associated with LGS in patients who have not achieved adequate seizure control with at least two other anti-epileptic drugs.  The PBAC considered the revised proposal for listing provided by the sponsor addressed its outstanding concerns regarding the cost-effectiveness of cannabidiol.

Patients with LGS, a rare yet severe childhood-onset epilepsy, now have access to PBS-subsidised Epidyolex® to treat their seizures if other antiepileptic drugs are inadequate.   And suppliers of medicinal cannabis products now have a template to expansion of PBS reimbursed indications!

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