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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!

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries.  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.  Pearce IP leaders are well recognised as leading IP practitioners.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced life sciences patent lawyer, providing IP leadership for product development and commercialisation across global markets in pharmaceuticals, biopharmaceuticals, medical technology and devices, digital health and diagnostics – from initial scoping through to post-launch. She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

Sian Hope

Sian Hope

Associate Lawyer

Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.

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