MSD Australia & New Zealand is astonished that after eight years of dialogue and consideration, the Pharmaceutical Benefits Advisory Committee (PBAC) which advises the Federal Government on medicines access has outright rejected a funding proposal that would have removed inequities of access to a cancer-treating immunotherapy in Australia.
The company is concerned that this decision will leave some cancer patients bereft of reimbursed treatment options, while foregoing an opportunity to deliver equity of cancer care to thousands of Australians, including those with certain rare cancers.
The MSD 'multi-cancer funding model' proposed that all usages of KEYTRUDA® (pembrolizumab) registered on the Australian Register of Therapeutic Goods (ARTG) for advanced or metastatic cancers be converted into immediate access via the Pharmaceutical Benefits Scheme (PBS).[1]
This assertion is bewildering given the proposal was developed with the explicit intention of removing immunotherapy access barriers, including for certain rare cancers, where the number of patients involved in a study is often too small to meet requirements for a PBS subsidy.[2]
Following ongoing consultation throughout 2024-25 with Rare Cancers Australia and leading oncologists, as well as the PBAC and Department of Health, Disability and Ageing, it was considered inappropriate for the proposed funding model to include medicines or indications that had not been registered on the ARTG.
Under the multi-cancer proposal, an estimated 700 Australian eligible cancer patients could have been suitable for reimbursed access to KEYTRUDA.An additional 5,200 eligible cancer patients could have had reimbursed access over the next four years. This would have facilitated funded access for certain patients with 11 rare or less common cancer sub types where there is currently no other immunotherapy on the PBS.[1]
Currently, each new indication registered on the ARTG requires a separate assessment by the PBAC to qualify for government funding. Of the 35 KEYTRUDA registered indications,[3] 15 are partially or fully funded through the PBS despite 40 reimbursement submissions.[1,4] The average time from a new ARTG registration to a successful PBS listing has been 447 days.[1]
MSD notes that it is eight years since the Federal Government first sought PBAC advice on the reimbursement of immunotherapies across different cancer types in response to a direct request from the then Minister for Health.[5]
MSD's initial multi-cancer funding proposal was deferred by the PBAC in December 2023, with the committee noting that "it would be appropriate and desirable to have a simplified process for listing future indications".[6] In September 2024 the PBAC advised that a simplified process would only be considered within certain tumour types. At both these milestones, the PBAC raised concerns with providing broad access that was not linked to registered indications and was supportive of a restriction which limited funded access to the registered indications.[1,7]
The PBAC again considered a broad multi-cancer funding proposal for KEYTRUDA at its July 2025 meeting where it issued a rejection. Throughout this process, the PBAC consistently raised Quality Use of Medicines (QUM) concerns about medicines being used outside their registered indications and stated its preference for the proposal to be aligned with TGA registrations.[1,7]
Multi-cancer or 'pan-tumour' funding models were introduced in Europe in 2017 and have been adopted by several countries. These models are noted for increasing speed of access and budget predictability.[8]
A pan-tumour funding model was first considered in Australia in 2017[9], followed by a multi-cancer proposal in 2023.[1] After eight years, Australia's pharmaceutical reimbursement advisory committee has now closed this opportunity.
"It's simply not good enough that after eight years of churn, the committee's answer to the pleas of the Australian cancer community for more affordable and equitable access to cancer care is an outright 'no'," said Chifumi Umeda, Managing Director, MSD Australia & New Zealand.
"For almost a decade the PBAC has continually shifted the goal posts on multi-cancer funding, making it impossible to find an equitable solution for Australian cancer patients."
"Without a clear change in approach by the Federal Government, there does not appear to be a path forward for multi-cancer funding in Australia," she said.
"Sadly, Australian cancer patients remain at the mercy of a painfully slow, inequitable and inefficient medicines funding system. It's a sad day when innovation and equity are dismissed in favour of the status quo."
"MSD is also deeply uneasy that the committee appears to be using Australians with rare cancers as a justification for the rejection, at a time when the rare cancer community has been the most vocal advocate for multi-cancer funding."
KEYTRUDA has been assessed by the Therapeutic Goods Administration (TGA) more than 30 times[3] since it was first reimbursed for advanced metastatic melanoma on 1 September 2015.[10]
"Today's decision means that some Australian cancer patients will not have equitable funded access to this registered treatment," said Ms Umeda.
