Stakeholders disappointed as HTA Review falls short on bold reform

Pharma News: Despite the closure of the Health Technology Assessment (HTA) Review consultation 2 nearly a month ago, stakeholders are still awaiting the Department of Health’s publication of the submissions online.

In a bid to improve access to innovative medicines, pharmaceutical companies such as Pfizer and GSK have voiced their concerns regarding the lack of alignment of proposed options in consultation 2 with the overarching goals of the HTA Review.

Pfizer emphasised disappointment over the “lack of bold reform to improve the value attributed to innovative medicines”. GSK echoed similar sentiments, stating that the proposed options “do not go far enough to deliver on the objective of the Review or for Australians” and “do not reflect the government’s broader vision set out in the National Medicines Policy (NMP)”.

Consumer Health Forum (CHF) emphasised the importance of a unified process to enhance access to health technologies while expressing concerns about potential execution challenges.

“Consumers are also worried about the way such a process will be executed. Proper unification will require a very sizeable amount of funding and HTA structure augmentation. The risk of a half-baked streamlining process will be borne by consumers, who will experience the loss of expertise of de-funded local HTA bodies. If this option is implemented, specialist bodies must be appropriately resourced to enable them to provide advice that is pertinent and up to date,” CHF said.

Addressing the proportionate assessment for cost-minimisation submissions, both Pfizer and GSK cautioned against approaches that hamper innovation or limit patient access to treatment options.

“The creation of a proportionate assessment approach is an important step in removing unnecessary pressure on our HTA bodies. However, building in a price reduction cannot be supported. Seeking to create a quid pro quo where faster processing can be achieved in exchange for cost reductions fails to solve the key problem that evaluation for low budget impact medicines is overly cumbersome,” Pfizer wrote in its submission.

GSK said the proposed option would negatively impact Australia’s attractiveness as a first launch market for innovative medicines and vaccines.

“Requiring offers of a lower price for cost-minimisation submissions does not address the objective or challenges identified in the Review and will not result in improved access for Australians. In the current system, cost-minimisation submissions often provide innovation that benefits patients at no additional cost to the government. The proposed option of requiring or incentivising offers of a lower price for cost-minimisation submissions will reduce competition, leaving patients and clinicians with fewer treatment options,” the company stated in its submission.

Medicines Australia raised alarms over options that contradict existing policies and agreements, warning of potential adverse impacts on pricing certainty and competition. As outlined in its submission, the proportionate assessment for cost-minimisation contradicts the premise of F1/F2 formulary split which has delivered significant savings to the government. The option would reintroduce pricing uncertainty for F1 medicines, contradicting the commitment to price certainty in Clause 7.3 of the Strategic Agreement between Medicines Australia and the government. In the case of F2 medicines, it has the potential to decrease competition, thereby diminishing the savings derived from price disclosure.”

Despite the concerns raised, CHF expressed support for streamlined processes that “deliver the same benefit to consumers at a cheaper price, as it will stimulate competition and lower prices for technology.”

On the issue of vaccine evaluation pathways, GSK advocated for mechanisms that prioritise the value of prevention and community benefits, highlighting the average of 1375 days for a vaccine to be listed on the National Immunisation Program (NIP).

“To drive efficiencies in the HTA pathway for vaccines and better access for Australians, the Review would be better placed to recommend mechanisms that embed recognition of the value of prevention. This includes taking a broader view of the health, economic and societal impact of interventions, an updated ‘willingness to pay’ and reduced discount rate,” GSK highlighted in its submission.

GSK cited the case of Bexsero, a meningococcal B vaccine, as a prime example of the disparity in access despite its proven effectiveness and approval by regulatory authorities. While Bexsero was approved by the Therapeutic Goods Administration (TGA) in 2013, with an ATAGI recommendation in 2014, GSK has been unsuccessful in securing NIP access for Australian children despite four submissions.

Australia’s Cell & Gene Catalyst, a national joint venture of AusBiotech and Medicines Australia, referred to a high-level principles-based framework for accepting and assessing real world evidence for cell and gene therapies, instead of randomised control trial evidence and surrogate health outcomes.

“Conditions treated by cell and gene therapies can be rare or extremely rare which means they can have small patient cohorts in Australia. This means recruiting participants for clinical trials is more challenging and generating randomised control trial evidence more difficult. Real world evidence (RWE) and broader societal, health and economic benefits can be transparently considered and used in HTA decision-making – potentially leading to faster, more equitable patient access,” the submission stated.

The ongoing discussions surrounding the HTA Review underscore the complex interplay between regulatory frameworks, consumer voice, industry perspectives, and government willingness for bold reforms heading to an election year.

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