13 FEBRUARY 2026 2 NEWS ausdoc. com. au
13 FEBRUARY 2026 2 NEWS ausdoc. com. au
Proposal to fund drugs without PBAC approval
A bridging fund for life-saving drugs is under government review.
ANALYSIS Jamie Thannoo WHEN the TGA approved cystic fibrosis drug Trikafta in 2021, the biggest barrier remained in place: the $ 250,000-a-year price tag to treat one patient.
About 2200 patients had to wait for the PBAC to make a positive recommendation to have a real chance of access. Unsurprisingly, given the taxpayer cash at stake for such a small cohort of people, it took time— some 13 months.
A government-commissioned review has now sketched out a potential system to subsidise medicines for 6-12 months before they are added to( or rejected from) the PBS.
Australian Doctor has not seen the full report, which was put together by the Health Technology Assessment Review Implementation Advisory Group, but understands a bridging fund is a big focus.
“ It would be a bandaid system as we try to increase the speed of regulatory approval to PBS reimbursement,” said Professor Andrew Wilson, the IAG chair and a former chair of the PBAC.
Professor Wilson, a public health physician at the University of Sydney, said this approach could be limited to treating conditions where other options were scarce and patients were desperate.
Australia has precedents, he pointed out, such as the short-term funding for difluoromethylornithine to treat neuroblastoma in children in 2024.
“ That is a condition that can be rapidly fatal,” Professor Wilson said.
“ That drug was still going through an evaluation process when the Health Minister decided to approve special payments for it.”
The government would still need to negotiate bridging prices with the company, which Professor Wilson said would likely be higher than the final PBS price.
A lobbying coalition of pharma companies and patient groups, called the Bridging Funding Coalition, has modelled a hypothetical bridging fund covering 18 cancer therapies over three years.
It said about 21,600 patients could have benefited at a cost to taxpayers of $ 334 million a year.
The group wants the next federal budget to commit taxpayer dollars to the reform.
However, Professor Wilson said the government would need time to develop such a complex policy, defining what counted as high unmet need and high therapeutic value and deciding how long a bridging period would last.
“ From our point of view, we do not want to distort the system in a way that is inequitable,” Professor Wilson said.
“ There is always going to be someone who is going to feel like they should have been recognised.
‘ It would be a bandaid system.’
Professor Andrew Wilson.
“ So, there is an issue of trying to balance the fairness of the system and individual patient needs.”
When asked if there was a material risk that drugs could receive early-stage funding only to be rejected by the PBAC because their benefits were limited, Professor Wilson said yes.
“ Even in Germany, which has a well-structured system, there are cases where companies with draw their drugs because they get to the end of the period and there is still no agreement.
“ It was certainly a concern for the review committee. It made it transparent to everybody that, if we go down this route, there are risks involved.”
A spokesperson for the Department of Health, Disability and Ageing said the government was still assessing the IAG report.
Live and let larvae
Jamie Thannoo THE TGA plans to significantly relax controls on the use of maggots for wound debridement, opening the door to a homegrown Australian medical maggot industry.
The watchdog says it is responding to calls from doctors who want to use maggots as an alternative to surgery or an add-on treatment for unresponsive wounds.
Currently, maggots are classified as Class 4( highest-risk) biologicals on the Australian Register of Therapeutic Goods, a designation for high-risk use of animal tissues and cells in treatments such as xenotransplantation. No maggot products have been registered in this category.
Doctors can still apply to use them through the Special Access Scheme, via the sole Australian supplier: NSW Health Pathology at Westmead Hospital in Sydney. NSW Health told Australian Doctor about 1-4 Australians used these maggots each week, but being forced into the Special Access Scheme was deterring doctors from using them more.
Last year, however, the TGA released a consultation paper saying maggots should not have been classified as Class 4 biologicals.
“ The use of medicinal maggots is clinically considered a low risk, with a high benefit-to-risk ratio when used for debridement,” it said.
The paper proposed reclassifying medicinal maggots as a Class 2( low-risk) biological, meaning less stringent regulatory requirements.