Health Department’s capacity claims under fire: Pharma industry demands transparency over PBAC submission deferrals

Pharma News: The Department of Health’s capacity crisis has sparked major concerns over patient access to essential medicines.

Yesterday afternoon, Medicines Australia met with senior representatives from the Department of Health and Aged Care to address the growing alarm within the industry following the government’s decision to defer a significant number of PBAC submissions from the March 2025 meeting.

Among the industry’s key concerns are the lack of consultation on the prioritisation process, the absence of an opportunity for sponsors to object or advocate for their submissions, and scepticism surrounding the PBAC’s claim that it can only assess 32 submissions.

There are also serious implications for co-dependent submissions, especially those already scheduled for MSAC consideration, and concerns over the negative signal this sends to global sponsors about Australia’s viability as a first-launch country.

The evaluation units’ capacity and broader utilisation of the HTA evaluator community, along with alternatives to avoid delaying submissions by an entire cycle, were also central topics of concern.

Medicines Australia CEO Liz de Somer described the meeting as “productive” but highlighted the critical need for collaborative efforts between industry and the government.

“We understand the PBAC determined to accept 32 submissions that are a mix of category 1 & 2 and resubmissions that require a full economic evaluation and propose to defer 24 (major) category 1 & 2 and 21 (minor) category 3 & 4 submissions,” said de Somer.

“It is essential industry and government work collaboratively on this matter, given the significant impact it will have on patient access to critical medicines as well as significant business planning consequences. Most importantly, we need to ensure that every possible option is explored to enable the submissions to be evaluated prior to July and not create ongoing delays to access for patients throughout 2025.”

As part of the discussion, several steps were agreed upon. The Department committed to working jointly with Medicines Australia to explore solutions that could expedite evaluations and PBAC consideration at both the March and July 2025 PBAC meetings. They will also explore an ongoing evaluation process and consider holding an intracycle meeting to reduce the number of submissions carried over to July.

Additionally, the Department will provide Medicines Australia with transparency into the criteria used by PBAC to make its triaging decisions and detail the deliberative processes undertaken. Importantly, it was confirmed that, consistent with past practice, PBS listings will continue during the caretaker period, contingent upon agreement between the Government and Opposition ahead of the election.

Further action points to prevent a recurrence of this situation include reviewing the Department’s evaluator panel to ensure sufficient capacity during peak submission periods. The criteria for appointing evaluators will also be scrutinised, ensuring that those with industry experience are not automatically disqualified if effective conflict-of-interest strategies can be implemented.

A review of PBAC and sub-committee capacity and meeting schedules is also on the agenda, with the aim of allowing for intracycle meetings to more comprehensively evaluate submissions. Additionally, Medicines Australia has secured a commitment for genuine consultation before members are notified if such a situation arises again.

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