Breast Cancer Network Australia (BCNA) has accused Pfizer of walking away from PBS pricing negotiations for tucatinib (Tukysa), leaving Australian women with metastatic breast cancer unable to access subsidised treatment.
The TKI is TGA-registered and available in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2+ breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Patients can access the drug privately for about $8,000 per treatment cycle, capped at a total cost of $64,000.
A November 2025 PBAC meeting recommended the drug for PBS listing on the basis of clinical need for additional treatment options in later lines of therapy, particularly for patients with brain metastases.
“The PBAC was satisfied that tucatinib in combination with trastuzumab plus capecitabine provides, for some patients, a significant improvement in efficacy over trastuzumab plus capecitabine alone,” the PBAC Public Summary Document said.
“The PBAC considered that, while multiple lines of treatment are available on the PBS, there is a high clinical need for effective treatments in later-lines for patients with brain metastases, where current options have limited efficacy.”
Pfizer, which acquired tucatinib in 2024, said the recommended price did not “reflect the value of this innovative medicine and its expected use in Australian clinical practice,” and confirmed the drug would not be listed on the PBS.
BCNA estimated around 300 women would benefit from tucatinib. The organisation said the US company was taking advantage of market instability caused by the Trump administration’s looming 100% tariffs on some imported pharmaceuticals, though it also directed criticism at the Australian government.
BCNA’s Director Policy, Advocacy and Support Services, Vicki Durston, said Australian women were still waiting for affordable access while women in comparable health systems had access for years.
BCNA called for the immediate establishment of a fully funded compassionate access program for all clinically eligible Australian women while Pfizer and the Australian Government resumed negotiations.
A Pfizer spokesperson said the Australian Health Technology Assessment system, while designed to ensure PBS medicines were cost-effective, could also limit access.
“Of all new medicines launched globally between 2012 and 2021, only 24% have been publicly funded in Australia. On average, it can take 466 days from when the TGA approves a medicine for it to be funded on the PBS. That’s 100 days slower than the OECD average and 300 days slower than countries like Germany, Japan and the UK.”
Pfizer said tucatinib was reimbursed in 34 countries including 21 OECD members, and that it was continuing to engage with the Department of Health, Disability and Ageing and the PBAC to achieve funded access.