We have spent the 21st century adding processes and additional language to our health technology assessment system, and in most cases, the expectation was that it would make it better for patients.
Paradoxically, and despite the collective best efforts, it has become even more cumbersome and characterised by longer delays for patients.
Delay, of course, is a euphemism for harm. In healthcare, harm means suffering and, in some cases, it means death.
We, as a collective, have made a terrible hash of it for patients. We all need to take responsibility for the problem and for the fix.
An uncomfortable truth for everyone is that nothing really happens in this system without stakeholder agreement. Many of the problems currently affecting reimbursed access to health technologies in Australia stem from co-design between government and stakeholders.
The industry consistently and understandably laments chronic underinvestment in the PBS, including in its new 'Bitter Pill' report. Fair enough. The problem is real.
Yet the industry has consistently agreed to the extraction of funds from the PBS, totalling over $30 billion, including in 2015, 2017, and 2021, without any real guarantee that the savings would be retained and reinvested in the program.
Who remembers the over $2.8 billion New Medicines Funding Guarantee? The funding guarantee with no funding.
It has relied on vague commitments, endless reviews and processes, all of which have landed patients in this increasingly rationed HTA nightmare.
This system is getting worse, not by accident, but by design. Parsimony has been the prevailing policy doctrine for the past 25 years.
Surely, the lesson of history is that there is no process or review worth paying for. Patients cannot afford another process or review.
A real problem is that the issue has been consistently misdiagnosed.
There is no world outside bureaucracy, the HTA institution, or the halls of academia where new processes and even more cumbersome language can be a solution to slow processes and cumbersome language.
More fire as the solution to a fire? More disease to cure the disease? More water to stop the flooding.
Yet we are now confronting the implementation of recommendations from the HTA Review that promise, and wait for it, new processes, and even more cumbersome language.
The HTA Review, officially announced in September 2021, is ending with two 'Delphi' surveys conducted to clinical-trial standards, in which a small group of anonymous stakeholders, selected through a non-transparent, closed-door stakeholder mapping exercise, is deciding the fate of critical public health program decision-making processes.
You literally could not make it up. Nobody can claim surprise when this ends badly.
In the words of George Orwell, "One has to belong to the intelligentsia to believe things like that; no ordinary man could be such a fool."
The system and its ossified processes are in urgent need of simplification.
The conversation about delays in 2026 is virtually the same as the conversation in 2000. The only differences are the magnitude of the delays and the focus on the vast array of new processes and language introduced to address the delays. That is, there are more processes to talk about in 2026. It is as simple as that.
In a 2012 article published in The Conversation, Alison Pearce described research funded by the University of Technology Sydney about how the time between TGA approval and PBS listing had increased steadily from 13.6 months in 2004.
In 2026, the time between TGA approval and PBS listing is now widely reported to be around two years, and in some cases, three years or longer.
The HTA Review's recommendations aim to return the time to around what it was in 2004 for some products that meet the revised definitions of high unmet medical need and high added therapeutic value, and navigate the process sequentially.
The qualifying products will need to meet the definitions currently being updated through the non-transparent, selective and anonymous Delphi surveys. Eyeroll. What could possibly go wrong?
How has the system changed since 2004 to make its timelines the goal for a small number of therapies in 2026?
Cost recovery, for a start. Paying for the process has led to longer delays. The system is also characterised by more processes, including some described, surely ironically, as streamlined and rapid, as well as detailed guidelines dominated by barely comprehensible language.
As implementation of the HTA Review recommendations gets underway, it has devolved into a discussion about the wording of technical inputs, including definitions, new 'streamlined' processes, and more opportunities for patient input.
It beggars belief that anyone can want or even support this outcome.
Patient input is indisputably a far more prominent feature of HTA decision-making than it was in 2004.
There was no legal requirement to include a consumer representative on the Pharmaceutical Benefits Advisory Committee until it was legislated as part of broader changes in 2000. A second consumer representative was added in 2015. Direct patient input as part of the submission process is also a relatively recent change.
It means the system was faster, with shorter listing times and fewer delays, when the advisory committee had no consumer representatives and received no direct patient input.
The simple truth is that as our HTA processes have become more accepting of patient input, they have also become characterised by more delays.
Why?
It is not that patient input has slowed the system or made it less responsive. It is well-intentioned from the patient's perspective.
The absence of a patient voice or input is not the problem. It has never been the problem. The problem is a legal framework that establishes price as the sole priority and imposes no formal obligations on the PBAC to consider the human impact of its advice.
Public Summary Documents consistently show the PBAC completely disregarding patient input. It 'notes' the input and then disregards it.
They are under no legal obligation to even consider patient input. On the contrary, the statutory obligation they do have requires them to prioritise price over patients. In disregarding patient input, the committee is acting consistently with its statutory framework.
In the absence of reforming this legal framework, why would anyone think that more patient input will make any positive difference?
The real risk, and it is an uncomfortable reality, is that more patient input actually makes things worse because it becomes more of an accoutrement. It becomes another tool for the HTA institution to justify more parsimonious outcomes. In that sense, it is a trap.
Remember the genesis of this legal framework that subordinates patients to price, or, as Better Access Australia chair Felicity McNeill PSM says, procurement over patients. It was created out of deep disdain for patients, reflected in a parliamentary debate during which our elected representatives dismissed patients and even called for the reimbursement of sugar-coated placebos.
Unless the 'original sin' of this framework is reformed, as Better Access Australia argues in a recent submission ahead of the Commonwealth's negotiations for new industry agreements, the risk is that new processes, language, and even patient input will have the opposite effect to what so many people hope.
