Government tightens PBS chokehold: Earlier NOI deadlines add new access barriers to medicines

The government is once again moving the goalposts on the Pharmaceutical Benefits Scheme (PBS) access, this time by overhauling the Notice of Intent (NOI) process for Pharmaceutical Benefits Advisory Committee (PBAC) submissions.

Starting with the March 2026 PBAC meeting, the Department of Health will require sponsors to lodge their NOI far earlier than the current 28-day timeframe. Sponsors must submit their NOI by 17 September 2025, along with the newly imposed requirement to provide “additional information with each NOI to support early planning”.

The policy shift comes as frustration grows over what critics see as more systemic barriers to PBS listings of innovative health technologies.

Senator Anne Ruston, Shadow Minister for Health and Aged Care, warned last week, “We are now hearing from the pharmaceutical sector that the government is putting much more difficult terms for listing medicines on the PBS after those medicines have received PBAC approval” and, further, “capping of the number of medicines to be considered by PBAC. This is another backdoor way that the government is avoiding listing medicines on the PBS.”

Stakeholder concerns are not without evidence. For the March 2025 PBAC meeting, 77 NOIs were lodged but only 32 submissions were actually evaluated. Capacity limits forced the deferral of 45 submissions, yet the Department issued invoices regardless, a move that angered both industry and patient advocates.

Meanwhile, the Department of Health’s latest performance data on PBS process improvements reveals a system that is slowing down rather than streamlining access. Between July 2023 and June 2024, 67.3% of initial submissions were recommended first time by PBAC. Yet, for submissions seeking a higher price for innovative medicines over existing alternatives, only 32.4% were recommended first time. Even when approved, these higher-priced submissions took an average of 164.7 days to move from PBAC minutes to PBS listing.

For sponsors lodging their pricing NOI form in week 4 and pricing package in week 5, the average time from PBAC minutes to PBS listing was 130.1 days (4.3 months). Yet this applied to just 15 out of 521 listings. By contrast, in 2022–2023 the average was 124.7 days (4.1 months), and in 2021–2022 it was just 101.8 days (3.4 months).

For all other applicants, the average delay blew out to 160.3 days (5.3 months), a marginal improvement on 2022–2023 (176.2 days or 5.8 months) but still slower than the 2021–2022 average of 143.3 days (4.8 months).

The Department of Health insists that the earlier NOI deadline will “support early planning,” and is pressing ahead with its regulatory change. From 2026 onwards, the NOI deadline will be locked in at eight weeks prior to the PBAC submission due date, formalising a process that many in the sector see as an additional bureaucratic choke point rather than a solution to the PBS bottleneck.

Liz de Somer, CEO of Medicines Australia, told Health industry Hub, “There is significant impact on sponsors, and we are working with the Department to ensure that any proposed changes include proper consultation and due consideration of the impacts on sponsors’ business planning, with an appropriate transition period, before they become a standard part of the process.”

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