Can we be so deeply entrenched in an existing way of thinking that we can no longer recognise the presence of a problem?
American philosopher Thomas Kuhn established the theory of 'paradigm blindness'.
In The Structure of Scientific Revolutions (1962), Kuhn argued that dominant paradigms shape what people inside an institutional system can see, measure, or even imagine. Problems that fall outside the paradigm can be unintentionally invisible to those operating within it.
The treatment of patient and clinician input to our health technology assessment (HTA) decision-making is a possible example of institutional paradigm blindness.
Why? This input does not neatly fit within the dominant HTA narrative because it is often subjective information competing with what are portrayed as objective truths. Of course, in the world of contested economic models, there is no such thing as objectivity. These models are constructed, manipulated sets of numbers, routinely and falsely presented as if they carry scientific validity.
When the statutory framework for HTA in PBS decision-making was legislated in the 1980s, the need for patient input was dismissed. In the parliamentary debate on the enabling legislation of that framework, Australia's elected representatives lamented patient demands for funded access to innovative medicines.
The point is that this system is a product of profound disregard, disrespect, and even disdain for patient perspectives. It is not that zero consideration was given to their involvement in decision-making. It is that the system was intentionally designed to remove them from any involvement.
The system was designed with the explicit intent of excluding patient input in decision-making. Its design was premised on the intentional and systematic discrediting of the patient experience. More on that tomorrow, but the direct impact of that design continues to reverberate.
Even today, as attitudes to patients have evolved, the institution continues to position their perspectives as peripheral to, or even in conflict with, its primary decision-making imperatives. It positions these perspectives this way because that is the intent of the system's original design, which was premised on patient demands for new medicines as a problem and contrary to the national interest.
This is straightforward. Our systems of HTA decision-making are designed on a fundamental mistrust of those affected by its decisions.
The problem this creates is an enduring disconnect with human consequences. How do you address that without correcting that 'original sin'?
A lack of human empathy does not drive this disconnect in 2025. HTA advisory committees are composed of genuine, caring people.
The point is that the prevailing in-built prejudice of the institutional framework, which prioritises fiscal considerations and views the human lived experience as intrinsically disruptive, combined with Kuhn's paradigm blindness, compounds the consequences of decisions made in the 1980s.
It is a serious limiting factor in reform.
Readers should put themselves in the position of key influencers proposing cosmetic reforms that leave the underlying structural problems created by the system's birth untouched.
The ongoing HTA Review is considering new and earlier opportunities for patient input during evaluations. How will that change outcomes? Patients are already involved in the process, often sharing their personal and heartwrenching experiences, which are consistently given minimal weight.
Sometimes, this input appears to be totally disregarded, which, by implication, is evidence of an institution that consistently discredits the lived human experience. At best, it is paternalistic. At worst, it is cruel and contemptible.
Has the review properly investigated the processes and frameworks, formal and informal, for consideration of clinician and patient input? Not the fact of the input, but its place in the decision-making hierarchy?
What is the point of creating more opportunities to provide input in the absence of reform of the underlying institution, including its statutory framework and consequent cultural drivers? The risk is that it could have the opposite effect of what is intended, undermining confidence in the decision-making process.
Conversely, it could help by further exposing the disconnect problem, creating new drivers for meaningful change. Fortunately, the second part of Kuhn's theory is that paradigm blindness ultimately creates problems to the extent it leads to paradigm shifts.
The real challenge is a decision-making framework that makes the disconnect inevitable.
The Pharmaceutical Benefits Advisory Committee (PBAC) operates within a narrow statutory framework. That framework, codified in the National Health Act 1953 (Act), imposes no obligation on the committee to incorporate, or even consider, patient and clinician input in its advice on submissions.
What we get is public acknowledgment and explanations of the actual input, but nothing on how it is weighted against other considerations, how it is incorporated into advice, or why it is disregarded.
The publication of the input is a welcome example of transparency. Yet, the complete absence of any detailed response to that input remains one of the most disconcerting features of Australia’s HTA decision-making framework. There is transparency on the input, but not on how it is considered or factored into the decision-making process.
What, if anything, does that silence reveal?
It is unlikely to be a matter of indifference or a lack of empathy.
Far more plausibly, it reflects an institutional architecture in which patient and clinician views occupy no formal place and therefore generate no obligation to engage, explain, or account for the disconnect between what patients and clinicians say and what the system decides.
In human terms, when it comes to patient and clinician input, avoiding an explanation might be preferable to directly dismissing it and confirming its lack of decision-making relevance. Or, it might genuinely reflect the institution's inability to recognise its paradigm blindness.
Even if they recognise the input and the human impact, other considerations are given priority.
Patient and clinician input sits outside the PBAC's statutory framework, which is to weigh the clinical benefit of a medicine or vaccine against the government’s fiscal interests. The committee is not lawfully permitted to recommend a product unless it is satisfied that the cost is commensurate with the clinical benefit.
It does not sound unreasonable, per se. However, its codification in the Act does not include any provisions for or obligation to incorporate patient and clinician input, making consideration of the latter discretionary.
The PBAC has two 'consumer' representatives. Yet, in the Act, their legal obligation is to contribute to the committee's decision-making process to ensure it meets the requirement to balance clinical benefits with the government's fiscal interests. They are nominally appointed as consumer representatives, but that role has no formal meaning. The fact is their statutory role on the PBAC is the same as that of its health economists, pharmacists, and clinicians.
This, combined with the discretionary status of patient and clinician input, creates a consistent and, at times, staggering disconnect between what patients and clinicians say and the outcomes that follow. Why not give the consumer representatives augmented statutory authority?
Recent examples include Pompe disease and newborn screening, access to continuous glucose monitoring, and now a breast cancer therapy.
Regarding Pompe disease, the Medical Services Advisory Committee (MSAC) determined that it knew better than patients, essentially rejecting their input, which suggested that being aware of the risk was less onerous than ignorance. MSAC actually issued a countervailing perspective, explicitly arguing that ignorance was preferable because of the risk of 'hypervigilance'. Regarding continuous glucose monitoring, MSAC identified its preferred priority populations, sidelining input that indicated worse outcomes in others.
There is an extraordinary paragraph (7.3) in the Public Summary Document detailing the PBAC’s decision not to recommend Novartis’ KISQALI (ribociclib) for use in combination with adjuvant endocrine therapy for resected early breast cancer at high risk of recurrence at the July 2025 meeting.
In a single paragraph, the committee acknowledges detailed patient input in support of the submission from “health professionals, individuals and consumer organisations including Rare Cancers Australia, Breast Cancer Network Australia, So Brave and Inherited Cancers Australia,” as well as support from the Medical Oncology Group Australia.
It is hard to imagine a stronger range of patient and clinician backing. The PSD documents patient and clinician testimony describing the limitations of current treatments, the emotional and mental health burden of side effects, the fear and anxiety associated with recurrence, and the clinical evidence and related experience.
Yet it appears that none of that mattered. The committee rejected the submission without responding to the patient and clinician input, beyond noting its existence. How does the outcome impact the patients and clinicians who made such a strong case in support of the submission, particularly their confidence in HTA decision-making?
Why the disconnect?
It seems implausible to deny a relationship between the decision-making framework, the persistent disconnect with patient and clinician input, and the outcomes produced.
Has the PBAC's statutory framework and its broader application, including to MSAC, produced secondary cultural issues, which, as Kuhn hypothesised, cannot even be recognised?
Patient and clinician input does not map neatly onto the categories that govern HTA decision-making, primarily cost, clinical benefit, and comparative effectiveness. These categories are rigid, tightly interpreted, and vigorously defended.
Once again, it is not a failure of empathy, although the consequences can be severe for those impacted.
It is that patient and clinician input becomes a matter out of place within an institutional framework that is formally and probably informally uncomfortable with discretionary and human concepts.
These are simple questions.
Is a disconnect between patient and clinician input and outcomes desirable? Given the extent of the disconnect, and who can argue that it is not regularly significant, how will providing more opportunities for patient and clinician input change decision-making? Has the HTA Review even contemplated these issues?
Is the risk that the government creates more opportunities for patients and clinicians to speak, without imposing any obligation for the system to listen, let alone act?
It stands to reason that the disconnect will persist in a system that invites patient and clinician input while simultaneously treating it as discretionary and optional within the institutional framework. New and earlier opportunities for input will be meaningless without supporting changes.
A meaningful reform agenda must address the disconnect.
This should include statutory recognition of patient and clinician input as a central consideration of the decision-making framework, explicit requirements for evaluating and weighting such input, transparent reasoning when patient and clinician input diverges from outcomes, and a supporting governance structure.