Delisting of goserelin 3.6 mg implant (Zoladex Implant) from the PBS
The Australian Government Department of Health, Disability and Ageing has advised stakeholders that the Pharmaceutical Benefits Scheme (PBS) listing for goserelin 3.6 mg implant (Zoladex Implant™) will cease from 1 November 2026 following a request from the sponsor, AstraZeneca.
The delisting applies to the following PBS item:
PBS CodeMedicineBrand1454MGoserelin 3.6 mg subcutaneous implant (as acetate) in pre-filled injection syringeZoladex Implant™
According to AstraZeneca, the decision has been made for commercial reasons. The company has also advised that the 3.6 mg formulation will no longer be available through private prescriptions once discontinued.
The Department stated that it sought to retain the PBS listing; however, medicine sponsors are private entities and cannot be compelled by the Government to continue supplying or listing a product on the PBS.
Significant Clinical Need Recognised
The Pharmaceutical Benefits Advisory Committee (PBAC) acknowledged the significant clinical need for Zoladex 3.6 mg, particularly for certain patient groups, and advised that its removal would create a high unmet need.
While alternative therapies remain available on the PBS, including Zoladex 10.8 mg Implant™ and other gonadotropin-releasing hormone (GnRH) agonists, the Department noted that these alternatives may not be clinically appropriate for all patients.
Patients currently receiving Zoladex 3.6 mg are encouraged to discuss treatment options and transition planning with their treating healthcare practitioner well in advance of the discontinuation date.
Potential Future Expansion of Zoladex 10.8 mg
AstraZeneca has advised that it is preparing an application to expand the approved indication and PBS reimbursement for Zoladex 10.8 mg Implant™ to include hormone receptor-positive breast cancer patients.
Any proposed changes will be assessed through the usual regulatory and reimbursement pathways, including review by the Therapeutic Goods Administration (TGA) and the PBAC.
Patient Access Arrangements
To support patients during the transition period, AstraZeneca has advised that eligible patients will be provided with free access to Zoladex 3.6 mg Implant™ for at least six months following its discontinuation.
The company has also indicated that alternative GnRH agonist options for anticipated premature ovarian failure are being investigated.
Further Information
Questions regarding the rationale for the delisting, future listing plans, or patient access arrangements should be directed to AstraZeneca on 1800 805 342.
The Department of Health, Disability and Ageing has advised that it will continue to provide updates to affected stakeholders as further information becomes available.