First medicinal cannabis product PBS listed

Health Minister Greg Hunt has highlighted this month’s new PBS listings, including access to a medicinal cannabis drug

From 1 May 2021, Australians living with Dravet syndrome have access to Epidyolex, a new cannabidiol treatment used in combination with at least two other anti-epileptic medicines on the PBS.

Epidyolex is only the second medicinal cannabis drug registered for supply in Australia, and the first one to be subsidised by the Australian Government on the PBS.

“Dravet syndrome is a rare, genetic epileptic encephalopathy that gives rise to seizures which don’t respond well to the standard medications,” the Minister said.

“The disorder begins in the first year of life in otherwise healthy infants.

“About eight out of 10 people with the syndrome have a gene mutation that causes problems in the way ion channels in the brain work. It is a ‘new’ mutation and is not usually inherited.”

According to the TGA, while there have been very few well-designed trials using medicinal cannabis, the evidence to support its use in the treatment of certain childhood epilepsies is the strongest, he said.

“It is estimated that around 116 patients each year will benefit from the listing of Epidyolex, who might otherwise pay more than $24,000 per year for the treatment. Instead, they will now pay only $41.30 per script or $6.60 if they have a concession card.”

CA Clinics, a network of medicinal cannabis clinics in Australia, welcomed the news, with medical director and addiction specialist Dr Mark Hardy saying that, “This is a huge jump for Australia’s medicinal cannabis industry”.

“As an authorised prescriber, my role is limited in what I can do for patients who cannot afford these treatments,” he said.

“Where indicated, I must currently direct them to other PBS listed products, some of which have already been tried without success, or carry unacceptable side effects.

“I hope this creates an environment in which more medicinal cannabis products could be considered for financial support by the Australian Government, and in turn open accessibility to a greater cohort of patients.” 

The Health Minister also noted the expansion of the listing of Asacol (mesalazine) for ulcerative colitis. The expanded listing takes in a new strength tablet designed to dissolve once it enters the intestines.

“In 2020, over 650 patients accessed a similar form of mesalazine through the PBS, and will benefit from this additional treatment option,” Mr Hunt said.

“Without PBS subsidy, patients might pay more than $1,400 per course of treatment with this medicine.”

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