When a close friend’s cousin with gall bladder cancer defied the odds after being treated with a medicine typically prescribed to treat breast cancer, Katrina Howe was motivated to learn how to make change.

Katrina is a Sir Roland Wilson scholar from the Department of Health. Her PhD research investigates the challenges associated with ‘off-label’ prescribing and repurposing of older medicines.

“Medicine use is described as ‘off-label’ when an approved medicine is used for an unapproved purpose,” Katrina explains.

“Off-label prescribing is legal, and can benefit patients in cases where there is no approved alternative treatment available, or where the treatments that are approved have been unsuccessful.”

Off-label use is most common for the treatment of rare and paediatric conditions.

“One downside is that off-label use of medicines is not subsidised by the government, so patients have to pay full price for the medicine.”

Katrina is looking at ways to incentivise the regulatory review of off-label uses with a view to improve equity of access to medicines in Australia.

Typically, medicines are approved for certain uses after pharmaceutical companies apply to the Therapeutic Goods Administration (TGA) for regulatory review.

Patents on pharmaceutical substances in Australia can last for up to 25 years. When the patent expires, it opens up the market for other companies to produce generic versions of the same medicine. Once medicines are off-patent, there are few incentives for pharmaceutical companies to apply for the use of the medicine to be approved for other purposes.

Through her PhD research Katrina is examining the extent to which off-patent prescription medicines are used off-label in Australia. She will also be investigating whether or not other countries have policies to incentivise the regulatory review of off-label uses, and will seek to propose strategies that could be applied in Australia.

“I’m working on ways to improve equity and access to medicines for people with rare conditions, like my friend’s cousin who had gall bladder cancer,” Katrina said.

Katrina hopes that her research will support the important work of the Department of Health in this area.

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