The PBS listing of Epidyolex is promising for Australian pharmaceutical cannabinoid developers also pursuing drug registration.
In a historic first, a medicinal cannabis drug has been listed on Australia’s Pharmaceutical Benefits Scheme (PBS), enabling Australians living with Dravet syndrome access to treatment for the rare form of epilepsy.
Federal health minister Greg Hunt announced last Friday that Epidyolex would be subsidised on the scheme from 1 May.
Epidyolex is pure cannabidiol (CBD) oil that has been shown to be effective in treating seizures associated with Dravet syndrome that presents within the first year of life in otherwise healthy infants. The treatment, which is considered highly beneficial to preventing seizures in children, can cost up to $24,000 per annum but patients will now pay $41.30 per script or $6.60 if they are concession card holders.
The PBS listing follows the Therapeutic Goods Administration’s (TGA) approval of the drug last September.
TGA approval comes after successful clinical trials and the greenlight for the drug from the Food and Drug Administration (FDA) in the United States in 2018.
The Pharmaceutical Benefits Advisory Committee had originally deferred its decision to pre-approve the PBS listing of Epidyolex in August to “enable further consultation with stakeholders”.
Along with being the first medical cannabis drug approved for the scheme, Epidyolex is one of only a few to be registered for supply in Australia by the TGA, following the 2012 registration of Emerge Health’s Sativex for the treatment of spasticity associated with multiple sclerosis.
Currently, other medical cannabis products on the market are unapproved, which means they are not included on the Australian Register of Therapeutic Goods (ARTG) and are only available on a very limited basis via authorised prescribers under the Special Access Scheme (SAS).
Promising move for other CBD drugs
Being registered on the ARTG means Epidyolex can now be prescribed by a doctor and a PBS listing means the treatment is more affordable for the patient or their family. Endorsement of Epidyolex as a mainstream medical product shows promise for other cannabinoid developers.
Small Caps spoke with Incannex Healthcare (ASX: IHL) chief executive officer Joel Latham about the announcement from Mr Hunt.
“We’re delighted that the Australian Government has both recognised and agreed that CBD-based Epidyolex is so beneficial to unmet patient needs that it is worthy of being subsidised – making it affordable to the general public,” he said.
“It marks the evolution of the cannabis sector in Australia. That is, away from generic cannabis oils and towards scientifically developed, pharmaceutical products that have undergone clinical testing and regulatory approval.”
“It represents the maturation of the cannabis market, which IHL has pre-empted, and why we have focused our clinical development model on FDA registration, patentability and global patient reach through widespread scientific and doctoral acceptance,” Mr Latham added.
Epidyolex was developed by GW Pharmaceuticals (NASDAQ: GWPH), a British biopharma company that generated product sales over US$300 million (A$388 million) in the 2019 calendar year and has only recently been acquired by Ireland-based Jazz Pharmaceuticals (NASDAQ: JAZZ) for US$7.2 billion (A$9.3 billion).
In April, the medication was also approved by the European Commission for the treatment of seizures associated with tuberous sclerosis complex (TSC). It was already approved in Europe for seizures associated with Dravet syndrome for patients aged two years and older, as well as in the US.
“GW Pharmaceuticals is a first mover in the medicinal cannabis space and had the foresight to develop cannabinoid-based pharmaceuticals made accessible to the medical community after clinical trials, scientific validation and FDA approval,” Mr Latham said.
“The board of Incannex has followed GW Pharma closely and we look forward to walking in their footsteps for our own proprietary medcan drugs under assessment.”
Incannex’s current clinical programs involve the research and development of cannabinoid-based drugs for the treatment of obstructive sleep apnoea, traumatic brain injury, lung inflammation, inflammatory bowel disease and rheumatoid arthritis.
The company’s current phase two obstructive sleep apnoea trial at Melbourne’s Alfred Hospital also has a secondary endpoint to monitor aspects of epilepsy.
So, while the registration of Epidyolex won’t directly benefit the company today, it remains excited about the possibilities the government’s recognition of the drug means for the future accessibility and affordability of its own medical cannabis drugs in Australia.