Epidyolex’s PBS listing shows promise for Australian pharmaceutical cannabinoid developers who are also seeking drug registration.

In a historic first, a medical cannabis drug was listed on the Australian Pharmaceutical Benefits Scheme (PBS), which gives Australians with Dravet syndrome access to treatment for the rare form of epilepsy.

Federal Minister of Health Greg Hunt announced last Friday that Epidyolex will be subsidized for the program from May 1st.

Epidyolex is pure cannabidiol (CBD) oil that has been shown to be effective in treating seizures related to Dravet syndrome that occur in otherwise healthy infants within the first year of life. The treatment, which is considered extremely beneficial for preventing seizures in children, can cost up to $ 24,000 per year. Patients now pay $ 41.30 per script, or $ 6.60 if they are a concession card holder.

The PBS listing follows the drug’s approval by the Therapeutic Goods Administration (TGA) last September.

After successful clinical studies and the green light for the drug, TGA approval will follow from the Food and Drug Administration (FDA) in the USA in 2018.

The Advisory Committee on Pharmaceutical Benefits had originally postponed its decision to pre-approve the PBS listing of Epidyolex in August to “allow further stakeholder consultation”.

In addition to being the first medical cannabis drug approved for the program, Epidyolex is also one of the few to be registered by the TGA for delivery in Australia after Emerge Health registered Sativex in 2012 for the treatment of spasticity related to multiple sclerosis .

There are currently no other medical cannabis products approved on the market, which means they are not listed on the Australian Register of Therapeutic Goods (ARTG) and are only available in very limited quantities through authorized prescribers under the Special Access Scheme (SAS).

Promising move for other CBD drugs

By registering with the ARTG, Epidyolex can now be prescribed by a doctor, and a PBS listing means the treatment is cheaper for the patient or their family. The recognition of Epidyolex as a popular medical device is promising for other cannabinoid developers.

Small Caps spoke to Joel Latham, CEO of Incannex Healthcare (ASX: IHL), about Mr. Hunt’s announcement.

“We are delighted that the Australian government has recognized and approved that CBD-based Epidyolex is so unfavorable to unmet patient needs that it is worth subsidizing – and making it affordable to the general public,” he said.

“It marks the evolution of the cannabis sector in Australia. That means moving away from generic cannabis oils and towards scientifically engineered pharmaceutical products that have undergone clinical testing and regulatory approvals. “

“It represents the maturation of the cannabis market that IHL anticipated and why we focused our clinical development model on FDA registration, patentability and global patient reach through widespread academic and PhD acceptance,” added Latham.


Epidyolex was developed by GW Pharmaceuticals (NASDAQ: GWPH), a UK biopharmaceutical company with product sales of over USD 300 million (A $ 388 million) in calendar year 2019, and most recently by Jazz Pharmaceuticals (NASDAQ: JAZZ) of Ireland was acquired) for $ 7.2 billion (AUD 9.3 billion).

In April, the drug was also approved by the European Commission for the treatment of seizures related to the tuberculosis complex (TSC). It has already been approved in Europe for Dravet syndrome-related seizures in patients two years and older, as well as in the United States.

“GW Pharmaceuticals is a pioneer in medical cannabis and had the foresight to develop cannabinoid-based medicines that would be made available to the medical community following clinical trials, scientific validation and FDA approval,” said Latham.

“Incannex’s board of directors has been following GW Pharma closely and we look forward to following in their footsteps as we review our own medicinal products, which are currently under review.”

Incannex’s current clinical programs include the research and development of cannabinoid-based drugs for the treatment of obstructive sleep apnea, traumatic brain injury, pneumonia, inflammatory bowel disease and rheumatoid arthritis.

The company’s current Phase 2 obstructive sleep apnea study at Alfred Hospital in Melbourne also has a secondary endpoint of monitoring aspects of epilepsy.

While Epidyolex’s registration won’t directly benefit the company today, it remains excited to see the opportunities that government approval of the drug will bring for the future accessibility and affordability of its own medical cannabis drugs in Australia.