Key facts
- AstraZeneca is withdrawing the drug Zoladex from Australia starting November.
- Zoladex is used to treat breast cancer and endometriosis by suppressing oestrogen production.
- Approximately 7,000 Australian women with breast cancer use Zoladex annually.
- The drug's removal is attributed to a lack of commercial viability for the manufacturer.
- A higher-dose, three-month formulation is being considered for approval, but its efficacy for all patients is questioned.
- AstraZeneca will provide free access to the monthly implant for eligible patients after discontinuation.
AstraZeneca is set to remove its vital breast cancer and endometriosis medication, Zoladex, from the Australian market and the Pharmaceutical Benefits Scheme (PBS) starting in November. This decision, which experts warn will significantly impact thousands of women, is attributed by the manufacturer to a lack of commercial viability.
Zoladex, a monthly implant containing Goserelin 3.6mg, functions by suppressing ovarian oestrogen production. It is crucial for managing endometriosis pain, aiding fertility preservation in women undergoing chemotherapy, and reducing recurrence risk in early-stage hormone receptor-positive breast cancer. Breast Cancer Network Australia estimates that around 7,000 Australian women with breast cancer rely on the drug annually, with 94,000 prescriptions filled in the past 18 months.
Nial Wheate, a professor of pharmaceutical chemistry, suggests the removal is likely a commercial decision, possibly linked to AstraZeneca's production of a higher-dose Zoladex 10.8mg formulation used for prostate cancer. He posits that manufacturing two different formulations may not be economically beneficial for the company. The Australian PBS currently pays $213.50 for the 3.6mg implant, a stark contrast to its cost in the US.
While AstraZeneca has applied to the TGA to list the higher-dose, three-month Zoladex treatment for breast cancer and endometriosis patients, concerns remain. Dr Nisha Khot, president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, stated that the three-month dose may not be effective for all patients currently on the monthly implant, potentially leaving them with costly alternatives or less effective treatments. AstraZeneca has committed to providing free access to the monthly implant for eligible patients for six months following its discontinuation.
Beyond Zoladex, Breast Cancer Network Australia also highlights increasing delays in listing other critical breast cancer drugs on the PBS, attributing this to policy changes and global uncertainty. Independent MP Monique Ryan has written to the health minister, criticizing the government's response and the lack of reform following a health technology assessment review, citing Zoladex as a prime example of medicine access failures.