The PBAC's decision to extend its previous recommendation for Vertex's cystic fibrosis therapy TRIKAFTA is positive progress but it appears heavily grounded in the federal government's financial and budget objectives for the PBS.
The outcome provides further evidence of a system in which the subordination of patient need to budget goals is effectively disguised by a health technology assessment (HTA) process.
This outcome is clearly significant but it does reflect the prioritisation of the subjective notion of budget impact.
Why is the PBAC doing this?
If it has just decided to take on this role of financial and budget gatekeeper, it needs to stop or be instructed to stop. It is constraining the minister and it was never intended or designed in law or policy to perform this role.
If the government has imposed this role on the committee, then it needs to be disclosed, including the detail of any instruction or decision-making parameters.
The PBAC and its individual members might contemplate how their work is being compromised and the impact on its global reputation as an HTA advisory body.
As an aside, it beggars belief that anyone truly believes the much-hyped HTA review can deliver anything of substance in a system that is now so overtly driven by the achievement of budget outcomes.
Realistically, the review is almost pointless unless it contributes to minimising the consideration of budget impact and excuses like 'opportunity cost' in the HTA process.
Of course, it must be convenient for a health minister to hide behind the PBAC, but it does involve shirking their obligations and responsibility to the system and Australian patients.
Put simply, it is the minister's job in law to fully consider the budget and wider impacts of a PBAC recommendation, not be constrained by the advice it includes.
We elect a government to make these decisions. We do not elect a government to hide behind an advisory committee on matters that are the lawful domain of a minister who is accountable to the parliament.
The minister simply needs to act to turn this TRIKAFTA recommendation into a reimbursement decision. That action might require disregarding aspects of the PBAC's advice and challenging the government's fiscal objectives for the PBS.
Patients will understandably welcome any outcome that can help progress TRIKAFTA to reimbursement.
Yet they might also question the decision-making process leading to another outcome that may or may not be implementable in the absence of ministerial action.
Reimbursed access to TRIKAFTA in Australia has and is being delayed because of a system that gives every appearance of openly subordinating patient need to the achievement of financial and budget goals.
Are we really expected to believe the delay in reimbursed access to TRIKAFTA reflects the superiority of our technical decision-making compared to the plethora of other developed countries that have already funded the therapy?
Australia really needs to avoid the attitude embodied by New Zealand's ridiculous assertion its PHARMAC is always right and everyone else is wrong.
The delay in access simply reflects less willingness to pay for innovation and new treatments. It really is that simple.
Some might welcome anything that 'squeezes' a biopharmaceutical company financially but everyone should worry about the consequences for patients.
Of course, a balance is required between policy objectives relating to patient access and budget impact. Ensuring the maintenance of this balance is the health minister's job. Unfortunately, patients are experiencing the current health minister's failure to ensure this balance in the form of lengthy access delays.
The notion Australia can demand consequence-free special consideration from the industry in an increasingly global pricing environment is both arrogant and absurdly naive.
Yet it is not the PBAC's job to consider these issues. It is the health minister's job to accept or reject a PBAC recommendation and then decide whether it is implementable based on balancing the committee's advice against wider considerations. These wider considerations have equal standing in law to the advice the committee includes with its recommendations.
Of course, this all presupposes access delays are not an intended consequence of the system's obsession with budget goals.
Regardless of the intent, the consequences are real for patients and they should be alarmed that Australia is now competing with New Zealand to be one of the last developed countries in the world to provide reimbursed access to TRIKAFTA.
