PBAC Rejects Multi-Cancer Funding Model for KEYTRUDA After Eight Years of Deliberation
核心洞察
Australia's Pharmaceutical Benefits Advisory Committee (搜索) (PBAC (搜索)) has rejected MSD's multi-cancer (搜索) funding proposal for KEYTRUDA (pembrolizumab) after eight years of dialogue, citing concerns about access restrictions to registered indications only.
The rejected proposal would have provided immediate PBS access to an estimated 700 eligible cancer (搜索) patients, with an additional 5,200 patients gaining access over four years across 11 rare or less common cancer subtypes.
Currently, only 15 of KEYTRUDA's 35 registered indications are funded through the PBS despite 40 reimbursement submissions, with an average 447-day delay from registration to successful listing.
Australia's Pharmaceutical Benefits Advisory Committee (搜索) (PBAC (搜索)) has delivered a decisive rejection to MSD's multi-cancer (搜索) funding proposal for KEYTRUDA (pembrolizumab), ending an eight-year process that began with a direct ministerial request for advice on immunotherapy reimbursement across different cancer types.
The PBAC (搜索)'s July 2025 decision has drawn sharp criticism from MSD Australia & New Zealand (搜索), which expressed astonishment at the outright rejection of a proposal designed to address inequities in cancer (搜索) immunotherapy access. The committee cited concerns that the funding model "was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration (搜索)" and "would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers (搜索)."
Proposed Model Would Have Expanded Access
Under MSD's multi-cancer (搜索) funding model, all KEYTRUDA usages registered on the Australian Register of Therapeutic Goods (ARTG) for advanced or metastatic cancers (搜索) would have been converted into immediate access via the Pharmaceutical Benefits Scheme (PBS). The proposal was developed following extensive consultation throughout 2024-25 with Rare Cancers Australia (搜索), leading oncologists, the PBAC (搜索), and the Department of Health, Disability and Ageing.
The rejected proposal would have provided reimbursed access to an estimated 700 eligible Australian cancer (搜索) patients immediately, with an additional 5,200 eligible patients gaining access over the next four years. This would have facilitated funded access for patients with 11 rare or less common cancer subtypes where no other immunotherapy is currently available on the PBS.
Current System Creates Significant Delays
The existing reimbursement process requires each new ARTG-registered indication to undergo separate PBAC (搜索) assessment for government funding eligibility. Of KEYTRUDA's 35 registered indications, only 15 are partially or fully funded through the PBS despite 40 reimbursement submissions. The average time from new ARTG registration to successful PBS listing has been 447 days.
KEYTRUDA has undergone more than 30 assessments by the Therapeutic Goods Administration (搜索) since its first reimbursement for advanced metastatic melanoma (搜索) on September 1, 2015.
Eight-Year Journey Ends in Rejection
The multi-cancer (搜索) funding discussion began in 2017 when the Federal Government first sought PBAC (搜索) advice on immunotherapy reimbursement across different cancer types. A pan-tumour funding model was initially considered in 2017, followed by a formal multi-cancer proposal in 2023.
MSD's initial proposal was deferred by the PBAC (搜索) in December 2023, with the committee noting that "it would be appropriate and desirable to have a simplified process for listing future indications." However, by September 2024, the PBAC advised that a simplified process would only be considered within certain tumour types.
Throughout the process, the PBAC (搜索) consistently raised Quality Use of Medicines (QUM) concerns about medicines being used outside their registered indications and expressed preference for proposals aligned with TGA registrations.
Industry Response and International Context
"It's simply not good enough that after eight years of churn, the committee's answer to the pleas of the Australian cancer (搜索) community for more affordable and equitable access to cancer care is an outright 'no'," said Chifumi Umeda, Managing Director of MSD Australia & New Zealand (搜索).
Umeda criticized the PBAC (搜索) for continually shifting requirements over nearly a decade, making it "impossible to find an equitable solution for Australian cancer (搜索) patients." She expressed particular concern that the committee appeared to use rare cancer patients as justification for rejection, despite this community being "the most vocal advocate for multi-cancer funding."
Multi-cancer (搜索) or 'pan-tumour' funding models were introduced in Europe in 2017 and have been adopted by several countries, noted for increasing speed of access and budget predictability. Australia's rejection of this approach leaves the country without a clear path forward for multi-cancer funding.
Implications for Patient Access
The PBAC (搜索)'s decision means that Australian cancer (搜索) patients will continue to face what MSD describes as "a painfully slow, inequitable and inefficient medicines funding system." Without a clear change in approach by the Federal Government, there appears to be no viable path forward for implementing multi-cancer funding in Australia.
"Today's decision means that some Australian cancer (搜索) patients will not have equitable funded access to this registered treatment," Umeda concluded, highlighting the ongoing disparity in cancer care access that the rejected proposal aimed to address.