Zoladex fallout exposes cracks in the social contract of medicines access

Patients prescribed Zoladex (goserelin) have been assured they will continue to receive treatment under AstraZeneca’s continuity program, following concerns over withdrawal of the therapy from the Australian market. However, patient advocates warn the scheme does little to resolve broader uncertainty and social contract fault lines surrounding access to medicines available on the Pharmaceutical Benefits Scheme (PBS).

Zoladex 3.6 mg subcutaneous implant is a cornerstone monthly therapy used in pre- and perimenopausal women with hormone receptor–positive (HR+) breast cancer. The patient program, initially described as an “access program” has been renamed a “continuity program” following feedback from clinicians who argued the original model, typically used for post-trial access, compassionate use or product familiarisation programs (PFPs), risked becoming administratively burdensome.

Rachelle Panitz, Managing Director of So Brave told Health Industry Hub that AstraZeneca has assured the patient community that the Zoladex continuity program will remain available for both existing and newly prescribed patients “until the very last patient requires it”.

Under the scheme, clinicians will register through an AstraZeneca portal before enrolling individual patients. Patients will nominate their preferred pharmacy, with AstraZeneca arranging direct courier delivery of Zoladex to the pharmacy for dispensing. Only limited patient information, including initials, date of birth and the nominated pharmacy address, will be shared with the company. The program process is expected to be rolled out to clinicians by September.

The logistics are substantial. With approximately 7,600 patients requiring ongoing Zoladex treatment, the continuity program could involve close to 90,000 dispensed prescriptions per year while patients transition to an alternative therapy.

Despite those assurances, Panitz argued that the continuity program remains entirely voluntary.

“The issue is that there isn’t surety. With this kind of program, it’s completely at the behest of the pharmaceutical company,” she said.

Vicki Durston, Director of Policy & Advocacy at Breast Cancer Network Australia (BCNA), said AstraZeneca’s decision to withdraw monthly Zoladex from the PBS should concern every policymaker.

“This is not the loss of a minor convenience. It removes an established monthly treatment option used to deliver therapy that improves survival, without an equivalent monthly replacement ready to take its place,” said Durston. “For months, clinicians, consumers, patient organisations, industry and government have worked tirelessly to mitigate the consequences, secure temporary access and work to find a long-term replacement.”

Attention is now turning to the Pharmaceutical Benefits Advisory Committee (PBAC), which is meeting out of session this week to consider Ipsen’s monthly intramuscular (IM) triptorelin formulation as the alternative treatment for Zoladex.

The proposal aligns with earlier recommendations from clinical experts, including Professor Fran Boyle AM, Professor of Medical Oncology at the University of Sydney and Mater Hospital in North Sydney, who referenced the SOFT and TEXT breast cancer trials in which triptorelin was used as ovarian suppression therapy.

“People affected by medicine access changes deserve clear, accurate information. We welcome PBAC’s consideration of alternative options and swift communication of their decision to patients,” Sarah Powell, CEO of Inherited Cancers Australia (ICA) told Health Industry Hub.

Panitz noted that the Zoladex supply situation has exposed broader concerns about the security of medicines already listed on the PBS, pointing to recent debates surrounding multiple sclerosis (MS) treatments as evidence of growing patient anxiety.

“A lot of distrust is coming through now from patients, which is understandable given that what they thought was certain is being taken away,” Panitz emphasised.

For years, advocacy efforts have focused on securing PBS listings for new treatments. Now, patients fear equal attention may be required to ensure existing medicines remain available as global most-favoured-nation (MFN) pricing policies increasingly influence commercial decisions in Australia.

“We are in uncharted territory. We don’t really have that surety that medicines already on the PBS will stay on the PBS,” she stated. “Australians need to be concerned… decisions are being made on behalf of patients. And quite honestly, would things have changed or been investigated had patients and clinicians not gotten very vocal about the proposed changes to Zoladex?”

Although the Zoladex continuity program provides immediate reassurance, the situation has eroded confidence among many patients.

“Companies cannot expect government and taxpayers to pay top dollar for new medicines while established treatment options can be withdrawn without a secure replacement, and the consequences left for patients, clinicians and the health system to manage,” Durston stressed. “Reward for innovation must be matched by responsibility for continuity of care, transparent communication and the impact of commercial decisions across the system.”

For now, patient organisations will continue monitoring the PBAC deliberations and broader policy developments while pressing for greater certainty that essential medicines will remain reliably accessible on the PBS.

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