A CBD product might soon be available and subsidised on the Pharmaceutical Benefits Scheme
Families of children with severe drug-resistant epilepsy might soon be able to access a subsidised medicinal cannabis product in Australia.
In January 2020 the Department of Health, in their submission to the Senate Inquiry into barriers to patient access to medicinal cannabis, flagged that Epidiolex – the CBD drug manufactured by GW Pharmaceuticals – was undergoing a priority registration review.
Appearing on A Current Affair on May 28th 2020, A/Prof John Skerritt, Deputy Secretary of the Commonwealth Department of Health, indicated
“There is a possibility that in a few months’ time we could have this medicine both approved and subsidised”.
This means that Epidiolex is currently being assessed by the TGA with the objective of having the drug registered on the Australian Register of Therapeutic Goods, making it possible for doctors to prescribe the product, as you would any other Schedule 4 medicine, without needing additional approvals via the SASB or AP pathways.
Drug registration would make Epidiolex easier to prescribe, but the costs would be insurmountable for most Australians. In the USA, where Epidiolex is registered for the treatment of Dravet and Lennox-Gastaut Syndromes (very severe forms of childhood epilepsy), a 100mL bottle (containing 100mg/mL of CBD) costs around USD$1,200.
At current exchange rates, that would equate to roughly AUD$1,800 per 100mL or $0.18/mg of CBD oil. Currently accessible unregistered CBD oils in Australia are priced closer to $0.10/mg, so without subsidies, Epidiolex would be more expensive than available unregistered products.
Government considering subsidies
Children with rare childhood epilepsies often require high doses of CBD typically between 10-20mg/kg/day to see effects. So for a 20kg child, that would mean up to 400mg per day. If each mg of CBD oil cost $0.18, that would mean a cost of over $70 per day or over $25,000 per year of treatment
However, Epidiolex is also before the Pharmaceutical Benefits Advisory Committee, which will be assessing whether or not the Commonwealth Government should subsidise the medication. If subsidised, the maximum someone could pay for a 100mL bottle could be reduced from AUD$1,800 to $41. That would turn a $25,000-30,000 per year medication cost into a potentially more affordable $600 expenditure.
This would be tremendously beneficial and we strongly support any PBS subsidies for regulated cannabis medicines.
Who would benefit?
Epidiolex has been registered in the USA to treat two specific forms of rare childhood epilepsy: Dravet Syndrome and Lennox-Gastaut Syndrome (LGS). However, it is only approved for patients >2 years old that are drug-resistant and is added onto their other existing antiepileptic medications. While it is estimated that more than 250,000 Australians currently live with some form of epilepsy, each epileptic condition is different and will respond differently to various medications.
At this stage, Epidiolex has only been demonstrated to be effective in the treatment of Dravet and LGS. If Epidiolex becomes registered on the ARTG (which it will) it would likely only be registered for treating those specific conditions. Meaning, doctors would be able to write prescriptions for Epidiolex if their patients had Dravet or LGS. And, although it’s technically against the rules, they could also prescribe Epidiolex “off label” to patients who have other conditions or symptoms for which Epidiolex is not registered to treat.
However, if Epidiolex gets onto the PBS (which seems likely), it would only attract a subsidy if it were prescribed to a patient with Dravet or LGS. Any “off label” prescribing would be done at normal retail prices.
How will this affect the rest of the medical cannabis industry?
Assuming Epidiolex gets registered and subsidised, this would cause a small drop in revenues for existing companies supplying epileptic children unregistered CBD products via the SASB and AP pathways.
It would also introduce a new competitor product to the Schedule 4 CBD category, although without subsidies, we don’t expect Epidiolex will pick up much market share as it is considerably more expensive than various already-available unregistered products.
It would, however, benefit the whole medicinal cannabis sector by finally providing these desperate families with the relief they so badly deserve. The most heart-wrenching stories of product unaffordability are pediatric epilepsy cases, as the conditions are so severe and the required doses are so high.
The media coverage these stories attract, and rightly deserve, reinforces the perception held by the general public that all medicinal cannabis treatments cost hundreds of thousands of dollars per year. In actual fact, the vast majority of patients spend closer to $5,000 per year on their medication. This is still far too expensive, but it’s nothing close to the costs that these families of epileptic children are confronted with. Reducing the frequency of these “high cost” news stories will likely mean that more people are prepared to consider accessing prescription cannabis medicines.
FreshLeaf Analytics, a division of Southern Cannabis Holdings, is the leading supplier of data about the medicinal cannabis industry in Australia. We have access to medicinal cannabis product, pricing and clinical data sets from some of Australia’s leading healthcare companies and organisations. The FreshLeaf Analytics team can be contacted on +61 2 8203 8741 or firstname.lastname@example.org