TGA Announces Delay to Decision on Epidyolex Subsidies

However, the PBAC's decision was "a deferment, not a rejection", according to a statement from FreshLeaf Analytics.

The Pharmaceutical Benefits Advisory Committee (PBAC) has official confirmed that it will not be supporting the subsidization of Epidyolex—the Australian counterpart to UK cannabis giant GW Pharmaceutical's CBD drug Epidiolex—for the foreseeable future.

The announcement represents a significant blow to the medicinal cannabis movement, as the drug's high out of pocket costs represents one of the biggest barriers towards patient access in Australia.

The PBAC decision is a deferment, not a rejection.  This is not an usual outcome for a drug funding request  – the process is somewhat of a negotiation and in this case the PBAC considered that, while there was a clinical need for additional treatment options for people with LGS and DS and the clinical data demonstrated that CBD oil was likely to be beneficial, in this case additional clarity on the restriction criteria, cost-effectiveness and cost of listing CBD oil was required by PBAC before a funding decision could be made. FreshLeaf Anayltics

To address this issue, GW Pharmaceuticals applied to the Therapeutic Goods Administration (TGA) for Epidyolex to be included under the government's the Pharmaceutical Benefits Scheme (PBS).

The subsidy was only intended to cover children suffering from rare forms of epilepsy, including Lennox Gastaut Syndrome (LG) and Dravets Syndrome (DS), and would have ensured that patients prescribed the drug would only have to pay $41 a month.

To put this into perspective, a recent report from FreshLeaf Anayltics—which operates as a division of Southern Cannabis Holdings—found that the lowest cost CBD currently available on the market retails for roughly $0.10 per milligram.

Although that may not seem particularly expensive, when you consider the fact that some patients—such as children with treatment-resistant epilepsy—can require between 400mg of CBD oil per day to effectively manage their symptoms, it becomes a very different story.

This means that the cost would amount to almost $40 per day—or roughly $14,000 every twelve months—which can be a staggering financial burden for some patients to shoulder.

And unfortunately for some patients the cost is even higher, as the dosage required is often determined by the user's bodyweight.

However, according to a statement from FreshLeaf Analytics, the PBAC's decision was "a deferment, not a rejection".

Furthermore, Freshleaf also expressed confidence that the TGA will imminently announce the inclusion of Epidyolex as a registered medicine on the Australian Register of Therapeutic Goods (ARTG).


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Hugo Gray
Hugo Gray

Hugo Gray is a Melbourne-based journalist with a body of work that covers a diverse range of topics, including immigration law, sex technology, and now the rapidly expanding cannabis industry.

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