Consultation on the Health Technology Assessment Review options paper is now closed, and the industry, more than any other stakeholder, needs to decide what constitutes success.
Medicines Australia has welcomed many aspects of the paper, including a pathway to accelerate the funding of significant new health technologies that address a high unmet medical need.
Yet the options paper pushes this proposal into further review and repudiates many of the industry's core positions, including reform of comparator selection and broader value assessments. It also proposes other changes that the industry has said would be unacceptable.
The association has admirably recommitted to arguing for including its core positions in the review's final report. Major revisions or anything specific is improbable because the options paper is dismissive.
Importantly, it is unrealistic for the industry to think it can pick and choose the HTA Review outcomes like a restaurant menu.
A trade-off is inevitable.
It is virtually impossible to identify any change in the almost eight-decade history of the PBS that did not involve a trade-off for the industry.
These trade-offs have always involved the Government making some concessions in return for the industry's agreement on reforms.
The most famous example was the agreement in 2005 to split the PBS into formularies based mainly on the patent status of a medicine. It was a significant step forward for the research-based sector that has delivered lasting benefits. Still, in return, the Government secured its agreement to introduce price disclosure that has delivered billions in savings.
In other words, the Government was the net financial beneficiary. It always is.
The HTA Review options paper is a case study of this historic reality.
The options paper proposes some concessions around the process but with various conditions and other changes that would benefit the government.
At what point does the downside risk of these conditions and other changes exceed the potential benefit of any proposals the industry favours?
There will be no streamlined pathway for cost-minimisation listings unless it includes a cost-reduction element.
There will be no accelerated pathway for breakthrough new technologies unless it includes a rapid re-review mechanism, explicit disinvestment framework, and the proposed changes to pricing.
Would these two-sided outcomes be acceptable to the industry?
The industry should be under no illusion that it can secure the proposals it favours without the conditions and other changes that could have profound long-term implications, most notably for patient access.
This is why this publication has consistently expressed caution about the HTA Review since it was announced in 2021. Put simply, be very careful.
Like every previous review, this review is a vehicle for the Government, and the industry's enthusiasm from the start suggested it did not appreciate and chose to ignore this reality.
The industry has focused on its one-sided 'roadmap' of ideas and given minimal consideration to the Government's objectives.
The Government was always going to use this process to secure changes to pricing policy. Has the industry contemplated how it will balance its interests with patient needs?
Despite claims otherwise, pricing is clearly within the scope of the review's terms of reference, not least because it is not explicitly precluded. Governments keep terms of reference broad and vague for this very reason, something else that was obvious at the start of the process.
Understandably, an industry would argue for its objectives. However, in a single-payer system, the only guaranteed outcome of a review process is that the Government will progress the proposals it wants.
This is very simple. The Government will never agree to comprehensive reforms unless it is the net beneficiary.
The industry's most senior decision-makers should be aware of the historical reality. There is no example in the history of the PBS and HTA decision-making where the Government has agreed to a change where it was not the primary beneficiary.
History matters because it is the only guide. Unfortunately, the industry sometimes chooses to ignore or rewrite history.
According to a briefing Medicines Australia recently sent to its members, "It’s important to remember this is the first time in 30 years that the HTA system has been comprehensively reviewed and it is an acknowledgment that medicines access delays are impacting Australians."
Yet, according to the options paper, "Since HTAs were introduced for the PBS in 1993 there have been several updates and other reform processes to HTA policies and methods."
This is a direct and clearly intentional repudiation of the association's claim. The options paper helpfully lists all the reviews since 1993. Does anyone think making incorrect claims boosts the industry's credibility?
Nor should anyone think the Government contemplates this review as a binary choice between faster-funded patient access or the status quo. It is far more complex.
To be clear, the Government has a vexed relationship with faster-funded access in that it can only ever be on its terms.
The options paper has made this clear and very easy for the Government.
The paper dismisses most of the industry's core positions. It proposes highly conditional process changes that would benefit a small number of health technologies while also suggesting major structural reforms that would deliver for the Government over many years and potentially decades.
The net cost to the Government of a small accelerated access program would be more than offset by the streamlined cost-reduction pathway.
The review's final report will be delivered to the Albanese Government in mid-April. Medicines Australia is arguing for a response by the 2024-25 Budget, which is unlikely, at least for its key asks.
The options paper pushes any new accelerated funding pathway into the future by suggesting the need for "extensive additional consultation outside of the review" to "identify and address additional practical implementation risks".
Any move to widen the remit and broaden the powers of the Pharmaceutical Benefits Advisory Committee could also take time, given the need for enabling legislation. The industry might lament this delay, but it should take the time to consider the implications properly.
The Government could deliver a staged response, pushing some recommendations into further consideration and review processes while quickly adopting others, such as the cost reduction reimbursement pathway, rapid re-review mechanism and disinvestment framework.
Arguably, a staged response is most likely. To confirm this reality, the industry can look to its experience with current strategic agreements. The Government quickly progressed the outcomes it supported and ran the clock on others.
Would the industry consider this outcome on the HTA Review, arguably the most likely, successful?
As an aside, anyone can challenge this publication for being negative. Fair enough. Yet surely the actual assessment is accuracy.
BioPharmaDispatch has correctly predicted and challenged this review's critical aspects from the start.
This has included its genesis, which has become apparent in the options paper's pricing proposals, the industry's enthusiasm for it, appointments to and the structure of the reference committee, and the terms of reference, which were finalised following a confidential consultation process.
We have also questioned the position of a probity advisor and the imposition of non-disclosure requirements. This has led to a profound lack of transparency. The government representative on the reference committee has an apparent conflict in their leadership of the review's administering secretariat.
The process reached its latest nadir with a consultation survey on the options paper. Most stakeholders, including patients and patient organisations, must declare a conflict of interest before submitting. Does anyone believe this is a coincidence or in any way appropriate?
Importantly, there is a way forward, but it requires an honest public discussion connected to reality that acknowledges the risks inherent in this process. The continued silence, servile and subservient adherence to the reference committee's confidentiality provisions will be a generational sell-out of Australian patients and the best interests of public health. It is your choice, but history will judge, and people must be clear about that.
