The vital medicine, made by AstraZeneca, will not be available from November, possibly leaving thousands of women without treatment
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Thousands of women could be left without vital breast cancer and endometriosis medicine when AstraZeneca removes its treatment from the Pharmaceutical Benefits Scheme (PBS) and the private market, experts warn.
Zoladex will no longer be available in Australia from November, as the ABC first reported, but some existing patients will still be able to access it for an additional six months.
Breast Cancer Network Australia also says there have been increasing delays to list other critical breast cancer drugs on the PBS, which they fear is due to policy changes in the US and global uncertainty.
What will this mean for women who use Zoladex, and what happens next?
Manufactured by AstraZeneca, the Goserelin 3.6mg implant, also known as Zoladex, is a breast cancer and endometriosis treatment that suppresses a patient’s ovaries from producing oestrogen.
It is also used for fertility preservation in young women receiving chemotherapy, and reducing the risk of the recurrence of early-stage hormone receptor-positive breast cancer. The treatment (a small pellet) is inserted into the skin once a month.
Breast Cancer Network Australia estimates about 7,000 Australian women with breast cancer access the medicine every year, but in the last 18 months there were 94,000 Zoladex prescriptions filled.
“It is designed to suppress the ovaries or put the ovaries to sleep for those people with hormone positive receptor breast cancer, so that means we try and reduce the production of oestrogen,” said BCNA’s policy director Vicki Durston.
Dr Nisha Khot, president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, said it provides crucial pain relief for women with endometriosis. It can be used to reduce pain symptoms before endometriosis surgery, before fertility treatment or for longer term pain relief.
“[Removing the medicine] is absolutely life-altering for women who are currently able to carry on with the resemblance of a normal life, to work, participate in the community. Without it perhaps they will not be able to function as they have been.”
Nial Wheate, a professor of pharmaceutical chemistry at Macquarie University, said the decision was likely commercial, due to the production of a higher-dose Zoladex 10.8mg, which is available for prostate cancer patients. The higher-dose pellet, which is administered every three months rather than one month, is currently not available to breast cancer or endometriosis patients on the PBS.
For price comparison, the Australian PBS pays $213.50 for the 3.6mg implant, while in the US it can cost more than $1,100 per implant. For the 10.8mg implant, the Australian PBS pays $714.89 while the US pays more than $3,100.
Wheate said there may not be economic benefit for AstraZeneca in manufacturing two formulations of the same medicine.
“There’s a low dose and the high dose and the former is being pulled from the market and from the PBS. That says to me that it’s not being pulled because of any PBS issue or any political issue,” he said.
“Companies run their facilities pretty much 24/7 when they’re manufacturing so they don’t have a lot of capacity to change things up. So if you want to increase the production of a current medicine or new medicine you’ve got to find space to do that.”
A spokesperson for the Therapeutic Goods Administration (TGA) told Guardian Australia that AstraZeneca stated a lack of commercial viability for its delisting of the medication.
But Durston said the pharmaceutical giant was not transparent in its decision.
“AstraZeneca has not been transparent on what those commercial and global reasons are … Australian women have the right to know why they’re doing this.”
Guardian Australia understands the decision was not directly linked to the Trump administration’s tariffs on pharmaceuticals or the president’s most favoured nation pharmaceutical pricing executive order.
AstraZeneca has applied to the TGA to list its higher-dose Zoladex treatment for breast cancer and endometriosis patients. Once approved it would be eligible to be added to the PBS.
In a statement, the company said that maintaining continuity of care for cancer patients is essential, and it would allow eligible patients to continue accessing the medicine for free for six months after it is pulled.
“We are committed to supporting access to the Zoladex monthly implant as a treatment option for eligible patients without alternative treatment pathways,” a spokesperson said.
“For these patients AstraZeneca will provide free access to the Zoladex monthly implant in Australia following its discontinuation from 1 November 2026.”
Unless the higher dose is available to women on the PBS, women would be left with limited choices, Khot said.
“One would be to spend the money for the higher dose, or use some form of other medication or way to control their pain which may or may not work for them,” Khot said.
Durston said that the three-month higher-dose treatment would not work for all patients currently on the 3.6mg implant.
“A lot of women are confused and angry. We’ve spoken to numerous clinicians around the world and the consensus is that the three-month dose will not be effective in all circumstances for those with breast cancer,” Durston said.
“For women who need to use aromatase inhibitors [a hormone therapy used alongside Zoladex] there is not sufficient evidence to suggest a three-month dose is effective for them. And right now they won’t have another option once this drug is removed from the Australian market.”
The Department of Health said it would work to ensure patients weren’t left without access to treatment. A spokesperson said a company “cannot be compelled by government to continue to list a product on the PBS”.
“The Department is continuing to work with AstraZeneca and other pharmaceutical companies to explore options that would mitigate the impact of the delist on patients as much as possible, including exploring options for patients for whom there are no PBS-listed alternative therapies,” they said.
Durston said she was concerned about the US tariffs on pharmaceuticals and Donald Trump’s most favoured nation pricing policy, which required pharma companies to provide the US with medicines at far lower prices.
There are implications for Australia’s PBS, which negotiates down medicine prices directly with those pharmaceutical companies.
“There are a number of other drugs that are being stuck in pricing negotiations that have been [going for] months and months,” Durston said.
Companies pushing for higher prices that are not supported by clinical evidence can lead to multiple submissions to the Pharmaceutical Benefits Advisory Committee, and delay a listing.
At the same time, the government is reviewing recommendations from its health technology assessment review, released in September 2024, to improve access to new medicines.
Monique Ryan, an independent MP and former paediatric neurologist, wrote to the health minister calling for alternative arrangements and pointed to the lack of reform after the review.
“While the government has taken over two years to work through the recommendations of the review, Australian patients are experiencing the medicine access failures the review was meant to prevent. Zoladex is a stark example,” she said.
“The PBAC has identified unmet need, women with breast cancer and endometriosis face losing a critical treatment from November, and the government’s inadequate response is … unfinished reform.”
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