Patient advocates are expressing concern about delays to new medications, believed to be because of the looming election, just days after a proposal to streamline the listing of a new category of cancer medications was rejected.
The Pharmaceutical Benefits Scheme (PBS) is the government program that subsidises medications, making them affordable for Australians. Not all medications are subsidised, with the Pharmaceutical Benefits Advisory Committee (PBAC) needing to recommend each drug that is subsidised under the scheme, and the conditions and restrictions that are to be put on who can access the medication at the cheaper price. It is a particularly important scheme for rural people, who rely more heavily on medications due to the lack of other health services.
The Department of Health and Aged Care says it has received notification that pharmaceutical companies plan to bring forward more than 50 major submissions for consideration at the March 2025 meeting, and cannot consider that many applications.
“This is an unprecedented number and exceeds both the current capacity of the contracted Health Technology Assessment (HTA) workforce for evaluation, and the number the PBAC can consider in one meeting,” said a statement on the PBS website.
The PBAC has decided to hold over more than half of the submissions to a later meeting, saying the decision has been taken very carefully given the potential implications for patients, clinicians and drug companies.
“In selecting submissions for the March 2025 agenda, the PBAC used its clinical judgment and experience, providing a consistent and standard approach across all submissions. This patient-centred approach considered: clinical need, high added therapeutic value and the nature of the condition.”
“Submissions held over from March 2025 will be considered at the PBAC’s July 2025 meeting subject to submission volume and capacity for that meeting.”
The Department told BioPharma Dispatch, a specialist news outlet for the pharmaceutical industry, they will only consider 32 of the 77 submissions at the March meeting, deferring the other 45 to July or November. The significant delay will not only affect patients who might benefit from those 45 medications, but is expected to have knock-on effects to all the other medicines that would otherwise be considered in the July, November and subsequent meetings, with no indication on how they intend to resolve the backlog.
The PBAC only meets three times per year, and routinely assesses around 50 submissions at each meeting. In previous years where there was a surge in submissions they would schedule an additional meeting day.
Industry insiders say it is not at all unprecedented for there to be a rush of new medicines to be considered before an election, as no new medications can be considered in the caretaker period. It is understood both industry and some patient bodies are seeking urgent meetings with officials and the Minister about the decision to limit the number of submissions under consideration.
Labor has previously deferred listing new medications on the PBS to save money. In 2011, then Prime Minister Julia Gillard intentionally denied people affordable access to new medications in an attempt to save the budget $100m over four years. The backlash was significant, triggering a parliamentary inquiry into the administration of the PBS, and the policy was dropped.
Two new cancer treatments from Bristol Myers Squibb are confirmed to be among the medications that have been bumped from March meeting agenda.
It comes just days after news broke that the PBAC had rejected of a proposed streamlined approach to accessing the life-saving PD-1/PD-L1 inhibitor class of cancer medicines, which can be used to treat multiple types of cancer.
Rare Cancers Australia CEO, Christine Cockburn, said it was yet another blow to patients who would benefit from these therapies.
“Our patients continue to wait, self-fund or die whilst industry and government negotiate.”
“RCA is on the record as advocating for pan-tumour listings since 2017 and this latest development is simply another example of the participants arguing over the life-jacket whilst the patient is in the water drowning,” she said.
Don’t miss any of the important stories from around the region. Subscribe to our email list.