Thousands of women in Australia could be left without vital breast cancer and endometriosis medicine when AstraZeneca removes its treatment Zoladex from the Pharmaceutical Benefits Scheme (PBS) and the private market, experts warn. Zoladex, also known as Goserelin 3.6mg implant, will no longer be available from November 2026, though some existing patients can access it for an additional six months.
What is Zoladex?
Manufactured by AstraZeneca, Zoladex is a breast cancer and endometriosis treatment that suppresses the ovaries from producing oestrogen. It is also used for fertility preservation in young women undergoing chemotherapy and to reduce the risk of recurrence in early-stage hormone receptor-positive breast cancer. The treatment, a small pellet, is inserted under the skin once a month.
Breast Cancer Network Australia (BCNA) estimates about 7,000 Australian women with breast cancer use Zoladex annually, with 94,000 prescriptions filled in the last 18 months. BCNA policy director Vicki Durston explained that Zoladex suppresses ovarian function in hormone-positive breast cancer patients, reducing oestrogen production.
Dr Nisha Khot, president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, emphasized that Zoladex provides crucial pain relief for women with endometriosis. It can be used before surgery, before fertility treatment, or for long-term pain management. Removing this medicine is life-altering for many women who rely on it to maintain a normal life, work, and participate in the community.
Why is Zoladex Being Removed?
Professor Nial Wheate, a pharmaceutical chemistry expert at Macquarie University, suggested the decision is likely commercial. AstraZeneca also produces a higher-dose Zoladex 10.8mg implant for prostate cancer, administered every three months. This higher-dose version is not currently available on the PBS for breast cancer or endometriosis patients.
For price comparison, the PBS pays $213.50 for the 3.6mg implant, while in the US it costs over $1,100. For the 10.8mg implant, the PBS pays $714.89, compared to over $3,100 in the US. Wheate noted that manufacturing two formulations may not be economically beneficial for AstraZeneca. A Therapeutic Goods Administration (TGA) spokesperson stated that AstraZeneca cited a lack of commercial viability for delisting, but Durston criticized the lack of transparency from the pharmaceutical giant.
Guardian Australia understands the decision is not directly linked to US tariffs or the Trump administration's most favoured nation pharmaceutical pricing executive order.
Impact on Existing Patients
AstraZeneca has applied to the TGA to list the higher-dose Zoladex for breast cancer and endometriosis. Once approved, it would be eligible for PBS listing. The company will provide free access to the monthly implant for eligible patients for six months after discontinuation, starting from 1 November 2026.
However, Dr Khot warned that unless the higher dose is PBS-listed, women will face limited options: paying out-of-pocket for the higher dose, or using alternative medications that may not be as effective. Durston added that the three-month dose may not work for all patients, particularly those using aromatase inhibitors, as there is insufficient evidence for its effectiveness in such cases.
The Department of Health stated it cannot compel a company to continue listing a product on the PBS but is working with AstraZeneca and other companies to mitigate the impact, especially for patients with no alternative therapies.
Broader Concerns for Drug Listings
Durston expressed concern about US tariffs and pricing policies affecting PBS negotiations. Several other drugs are reportedly stuck in prolonged pricing negotiations, delaying their PBS listing. The government is reviewing recommendations from its health technology assessment review, released in September 2024, to improve medicine access.
Independent MP Monique Ryan, a former paediatric neurologist, called for alternative arrangements and criticized the slow reform progress. She noted that the PBAC has identified unmet need, and women with breast cancer and endometriosis face losing a critical treatment without adequate government response.
