Cancer patients are being ‘abandoned’, advocates say, as access to recommended treatment waits on pricing negotiations.
Patients are being “abandoned”, patient advocates have said following news that pricing negotiations between Pfizer and the Department of Health, Disability and Ageing to list the cancer drug tucatinib on the PBS have ended without a resolution.
However, in what may be hopeful news that the parties can agree on pricing, TMRunderstands that discussions between Pfizer, the Pharmaceutical Benefits Advisory Committee and the federal health minister regarding affordable access to tucatinib are still ongoing.
The news comes as figures show that the average time between a TGA approval and PBS listing of new drugs has risen to almost two years.
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According to biotech company Amgen, which tracks the Australian patient access gap, the average time between TGA approval and PBS listing for new drug indications and populations is 726 days. That’s an increase of 135 days since 2024, when the average was 591 days.
Medicines Australia said its data showed that new first in-class medications took an average of 466 days between TGA approval and PBS listing.
The PBAC recommended tucatinib (Tukysa) be listed on the PBS in November last year.
Tucatinib crosses the blood-brain barrier and has been shown to improve outcomes in patients with HER2-positive breast cancer that has metastasised to the brain.
Clinical trial results have shown that tucatinib improved the treatment response in those patients, delayed the development of new brain lesions and improved overall survival by an average of nine months.
Last month, a TGA spokesperson told TMR’s sister publication HSD that it was not concerned about drug shortages in the midst of the fuel crisis and war in the Middle East.
Breast Cancer Network Australia (BCNA) said the breakdown in negotiations meant women with metastatic breast cancer were being “abandoned” and left to deteriorate from an incurable disease.
The BCNA said patients will continue to pay between $7000 and $9000 per treatment cycle, with a capped total cost of $64,000.
The breakdown in negotiations was a result of US pharmaceutical companies such as Pfizer “digging in their heels” against the Australian government’s pricing model in response to the escalating trade tensions between the US and Australia, the BCNA said.
“This is not a policy inconvenience,” BCNA’s director of policy, advocacy and support services Vicki Durston said on Tuesday.
“This is what failure looks like when women are left to deteriorate from an incurable disease while government and a billion-dollar pharmaceutical company say there is no way forward,” Ms Durston said.
“BCNA will not accept women being abandoned in this way.
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“What is needed now is leadership, urgency and an immediate pathway that stops more women being left to suffer.
“Australian women are still waiting to affordable access to tucatinib while women in comparable health systems have had access for years and that should outrage the Australian public.”
In the UK, tucatinib was recommended by the National Institute for Health and Care Excellence in 2022 and is available through the NHS for women with advanced or metastatic HER2-positive breast cancer.
In December last year, Amgen said of the 67 medicine and population pairings – drug recommendations for specific patient groups – that received a positive PBAC recommendation in 2025 up to the September intracycle meeting, only 26 progressed to PBS listing.
Amgen said some sponsors had to make several attempts to secure a positive PBAC recommendation, which a major contributor to the delay in approvals.
Amgen’s Australian Patient Access Gap Tracker shows that 70% of “ever cost-effectiveness analysis” medicine and population pairings – medicine and population pairings that have had at least one submission based on a cost-effectiveness analysis – went through several submissions to PBAC between 2021 and 2025.
