Article: Cannabis & CBD Pharma NewsNews Does medicinal cannabis actually help Australian patients?

There have been more than 7,500 approvals for medicinal cannabis in Australia since legalisation in 2016 – so why don’t we know if it is helping patients?

Access to medicinal cannabis for patients was legalised in Australia in 2016, allowing doctors to request permission to prescribe from the Australian government. Prescription occurs mostly on a case-by-case basis involving evidence that patients have failed to benefit from available conventional prescription medications. Since legalisation, a few thousand Australians have been prescribed a medicinal cannabis product.

Despite this, many tens of thousands of Australians continue to self-medicate with illicit medicinal cannabis. This is at least due to the difficulty and cost involved in accessing a legal prescription. Additionally, doctors generally do not feel well-educated around the use of medicinal cannabis products, with specialists often feeling that there is inadequate evidence to support their use in specific conditions.

The Therapeutic Goods Administration (TGA), Australia’s medicines regulatory body (akin to the FDA in the USA and EMA in Europe), is currently collecting some potentially useful information from doctors prescribing medicinal cannabis around the progress of their patients. However, the TGA does not appear to be analysing or disseminating this information for use by health professionals or the patient community. Here we explore how the Australian government might be missing a key opportunity for research into medicinal cannabis and what might be done to address this.

Patient access pathways

First, we will explain how Australians obtain a medicinal cannabis prescription. Australia has chosen to incorporate medicinal cannabis into our existing health regulatory framework governing unregistered medicines. In Australia, drugs that doctors prescribe conventionally have obtained ‘registration’ with the TGA. To obtain registration, a drug sponsor is generally required to run large-scale clinical trials proving safety and efficacy and provide the resulting evidence to the TGA. With one exception (Nabiximols, aka ‘Sativex’), this process has not been completed for any medicinal cannabis products in Australia. This means that the more than 50 other medicinal cannabis products in Australia, including oils, capsules, sprays and botanical material, are ‘unregistered’ medicines.

There are two main ways Australian patients gain access to unregistered medicines: The Authorised Prescriber Scheme and the Special Access Scheme Category B (SAS-B). So far, around 60 Australian doctors have been granted Authorised Prescriber status for a cannabis medicine, meaning they can freely prescribe to a specific class of patients directly under their care. Becoming an Authorised Prescriber is an onerous, time-consuming process and restricts the prescriber to one medicinal cannabis product and one patient class. The most common example of Authorised Prescribers are paediatric neurologists prescribing the FDA-approved cannabidiol product Epidiolex to children with refractory epilepsy under compassionate access schemes in New South Wales and Queensland.

Authorised Prescribers are only required to notify the TGA within 6 months of prescribing an unregistered medicine to a patient. So accurately determining how many people are currently accessing medicinal cannabis through this scheme is difficult to ascertain, although it has been estimated to be between 20% and 30% of Australian medicinal cannabis patients.

The remainder of patients receive access to products via the SAS-B pathway, which allows doctors to request a prescription for an unregistered medicine for a specific patient on a case by case basis. Approval is granted by the TGA but may sometimes require additional State/Territory Health department approval depending upon patient location and product choice.

The number of individual approvals through the SAS-B pathway has increased from a handful per month in early 2018 to over one thousand per month as of April 2019 (see Fig 1). Each approval represents a prescription authorisation for an individual patient, usually for an amount of medication that will last between one and twelve months.

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