TGA changes to prescribing pathways: why product substitution is good for patients

The Therapeutic Goods Administration (TGA) recently made significant changes to the medicinal cannabis prescribing pathways in Australia.[1] The streamlined application process will reduce the amount of admin for prescribers – and that’s not the only positive outcome. Patients will benefit greatly from these changes, as they can now access a wider range of medicinal cannabis products.

What are the changes?

From the 22nd of November 2021, the TGA now approves Special Access Scheme (SAS)[2] and Authorised Prescriber (AP)[3] applications for medicinal cannabis products based on their active ingredients, rather than their brand name. There are five categories which classify products by their cannabinoid content.[4]

  • Category 1 - CBD medicinal cannabis product (CBD ≥98%)
  • Category 2 - CBD dominant medicinal cannabis product (CBD ≥60% and <98%)
  • Category 3 - Balanced medicinal cannabis product (CBD <60% and ≥40%)
  • Category 4 - THC dominant medicinal cannabis product (THC 60-98%)
  • Category 5 - THC medicinal cannabis product (THC ≥98%)

Simply put, the CBD content of these products decreases as the category number increases. The THC content across all five categories is interchangeable with cannabinoids other than CBD.

Category 1, 2 and 3 products, which are CBD-based, are now included in the ‘Established history of use pathway’ for Authorised Prescribers.[5] This means that approval from a Human Research Ethics Committee (HREC) or specialist medical college endorsement is no longer required to prescribe these medicines. However, authorisation to prescribe THC-containing products (classified as a Schedule 8 drug [6]) is still required.

Why these changes are good for patients

In the previous system, TGA approvals were only granted for specific branded products. If that particular medicine became unavailable (which is a fairly common occurrence), patients required a new prescription and a new SAS-B approval. This requirement wasn’t ideal and resulted in additional costs for patients and admin for prescribers.

Prescribers are no longer limited to specific products with the new changes. Doctors can now obtain TGA approval for an active ingredient category and then prescribe any of the products within the approved category. 

However, the product format (e.g. dried flower, oil, capsule, etc.) must still be specified on the application. As an example, a patient seeking to switch from an oil product to a flower product for chronic pain would still need to obtain a separate approval.

Despite this, freely switching between similar products without needing additional approvals is a major improvement. It appears that patients using dried flower products are set to benefit the most, as these products often experience supply interruptions. With seamless product substitution, patients will always have options for accessing the medicines necessary for their treatment.

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