Historic PBS listing for Australians with a rare epilepsy condition

In a historic first, Australians living with a rare form of epilepsy will have access to a medicinal cannabis drug, which is being listed on Australia’s Pharmaceutical Benefits Scheme (PBS) for the first time.
From 1 May 2021, Australians living with Dravet syndrome, will have access to Epidyolex® (cannabidiol), a new 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 disorder begins in the first year of life in otherwise healthy infants.
About 8 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.
Australia’s medicines regulator – the Therapeutic Goods Administration – says that, while there have been very few well-designed clinical trials using medicinal cannabis, the evidence to support its use in the treatment of certain childhood epilepsies is the strongest.
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.
We are also expanding the PBS listing of Asacol® (mesalazine) for ulcerative colitis, an inflammatory bowel disease, with a new strength tablet designed to dissolve once it enters the intestines.
Inflammation is a normal way for the immune system to defend the body when it’s fighting off invaders, such as bacteria or viruses. Usually, the inflammation disappears once the invaders are destroyed. With ulcerative colitis, a problem with the immune system causes the inflammation to continue, damaging the walls of the digestive tract.
In 2020, over 650 patients accessed a similar form of mesalazine through the PBS, and will benefit from this additional treatment option. Without PBS subsidy, patients might pay more than $1,400 per course of treatment with this medicine.
Each of these listings has been recommended by the independent Pharmaceutical Benefits Advisory Committee.
Since 2013, the Australian Government has approved over 2,600 new or amended listings on the PBS. This represents an average of around 30 listings or amendments per month – or one each day – at an overall investment by the Government of $13 billion.
The Government’s commitment to ensuring that Australians can access affordable medicines, when they need them, remains rock solid.

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