The Australian Government sets the rules for reimbursing medicines and vaccines. Many might assume the rules are designed to meet patients' needs. They do not, in any way, unless by needs you mean access some of the time and conditionally. Why? The legislated rules prioritise one thing, which is price.
The Government will fund a treatment provided the price meets the institutional framework's highly subjective view of value.
The simple and indisputable truth is that the politicians who briefly debated adopting this system almost 40 years ago could not have conceived of the institution it would create. That debate has created a significant industrial complex.
Equitable access is the common refrain in this system. Do we have a clear, shared understanding of what that means? Or does the institution operate within its own definition? Have we even debated what it means?
The Government fiercely protects its existing legal HTA framework. It also protects its role as the dominant payer for medicines and vaccines.
Australia spends a lot on health each year. The Australian Government accounts for well over $100 billion of that spending. This is not a charitable system. Virtually nobody works in this system or supplies a product for free. Clinicians, manufacturers, and suppliers rightly expect fair remuneration. If a company withdraws a product because pricing within the rules becomes commercially untenable, it is the Australian Government and only the Australian Government that can choose to step in.
That reality helps explain the ZOLADEX Implant situation.
The irony is that this is not a clear story about health technology assessment turning its back on patients. It is a story about pricing policy. ZOLADEX was listed on the PBS in 1991, two years before the requirement for pharmacoeconomic evaluation and its 'price first' framework was formally introduced.
The reimbursement price for ZOLADEX has halved over 35 years. Why would anyone be surprised in 2026 that a manufacturer cannot sustainably supply a product at half the price it received 35 years ago? That is before the realities of international benchmarking.
This is a strange system.
Companies withdraw products from the PBS all the time, and for all sorts of reasons. Eight items were removed from the PBS on 1 June. Commonly, they are withdrawn for commercial reasons, and in most cases, another brand of the item remains reimbursed.
ZOLADEX is unusual because it is an old, off-patent product that is difficult to produce, and there are no generics in Australia. The absence of generics is revealing about the price.
A company making a rational decision about a cancer medicine based on commercial considerations is one thing. Our HTA institution deciding not to fund a proven treatment to reduce the risk of breast cancer recurrence is another.
At its July 2025 meeting, the Pharmaceutical Benefits Advisory Committee rejected the listing of Novartis' KISQALI (ribociclib) for use in combination with adjuvant endocrine therapy for resected early breast cancer at high risk of recurrence.
The committee acknowledged an extraordinary and overwhelming breadth of support from health professionals, individual patients and consumer groups, including Rare Cancers Australia, Breast Cancer Network Australia, So Brave, Inherited Cancers Australia, and the Medical Oncology Group of Australia.
Submissions described the limits of current therapies, the relentless mental health burden of side effects, and the fear of recurrence. Clinicians spelled out unmet need and the clinical evidence.
The committee rejected the submission, and by implication, patient and clinician input. The public summary document notes patient and clinician testimony and then moves on without explaining how, or even whether, those voices affected the assessment. It also suggested that treatment is appropriate for patients with metastatic disease.
Which is worse?
A company removes a dose of breast cancer medicine from the PBS for commercial reasons and commits to continuing to supply it to patients for free while it secures a listing for a higher dose. Or, an HTA advisory committee that disregards patient and clinician input, specifically in relation to stress and mental health considerations, and suggests delaying treatment until it is literally too late and the patient is close to death.
The answer is obvious.
