Women left waiting as pricing standoff blocks access to another essential medicine

Women with HER2-positive metastatic breast cancer will miss out on another life-extending treatment after pricing negotiations between the pharmaceutical company and the Federal Government failed.

Despite receiving a positive recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) in November 2025, Tukysa (tucatinib), will not be listed on the Pharmaceutical Benefits Scheme (PBS) after Pfizer and the Labor Government were unable to reach agreement on price.

“For women living with HER2-positive metastatic breast cancer, particularly those with brain metastases, this is devastating news,” said Breast Cancer Network Australia (BCNA) Director of Policy & Advocacy Vicki Durston.

The decision places Australia further behind comparable healthcare systems, with Tukysa already available in the United Kingdom since 2021 and Canada since 2022.

“Australian clinicians have told us they want to prescribe it because it is an effective and generally well-tolerated treatment option for women who may benefit. Once again, a medicine recommended by Australia’s independent experts has failed to reach patients because agreement on price could not be achieved,” stated Durston. “Women with metastatic breast cancer should not be caught in the middle of pricing negotiations.”

The latest access failure has intensified scrutiny of Australia’s approach to pharmaceutical pricing, particularly as global pressures reshape how companies assess the commercial viability of launching new medicines in different markets.

At the centre of the debate is the Most Favoured Nation (MFN) drug pricing policy, introduced under the Trump Administration to reduce drug prices in the United States. Its international consequences are becoming increasingly visible, with early trends pointing to fewer innovative medicine launches and a growing risk of market withdrawals.

Federal Health Minister Mark Butler has recently acknowledged the growing pressure created by global price referencing, stating that “reducing US prices creates price pressure in every other market. Over time, Australian medicine prices are likely to be used in international basket or reference pricing to benchmark prices in the United States.”

He has also warned of the “chilling effect on pharmaceutical companies’ willingness” to bring innovative medicines to Australia “especially given the disciplined pricing model of our PBS.”

The tension highlights a widening gap between regulatory approval and patient access. While the PBS currently subsidises around 950 medicines, an estimated 3,000 additional prescription medicines approved by the regulator remain unreimbursed.

Tukysa is not an isolated case. Last year, Pfizer did not list Cibinqo (abrocitinib), a treatment for severe atopic dermatitis, on the PBS despite a PBAC recommendation in November 2024. The company determined that the expected net price, combined with the risk-sharing arrangement (RSA), made the listing commercially unsustainable. Layering the RSA on top of an already low net price meant the post-rebate price failed to reflect the value of innovation, leaving patients without access.

The MFN debate has now escalated internationally, with the United States launching an investigation into Germany’s pharmaceutical policies over what it described as “persistent underpayment” for medicines, as Germany seeks to reduce healthcare costs, including pharmaceutical spending.

Other countries are also reassessing how they fund access to new therapies. In Switzerland, a dedicated fund for new drug launches has been proposed as a response to MFN pressures. It may be financed by cantonal taxes, while other less popular options under consideration include supplementary health insurance and savings from other areas of the healthcare system.

Against this backdrop, the pharmaceutical industry is shaping the political and policy narrative on the HTA reforms ahead of high-stakes negotiations with the Federal Government, as Medicines Australia prepares to engage Federal Health Minister Mark Butler on 1 July at the commencement of Strategic Agreement discussions.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.