At its July 2025 meeting, Australia’s Pharmaceutical Benefits and Advisory Committee (PBAC) rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in advanced or metastatic cancers. MSD had proposed that Keytruda® be PBS listed for all usages registered on the Australian Register of Therapeutic Goods (ARTG) for such cancers.
However, the PBAC considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”
MSD said the decision was “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”.
In October 2024, PBAC had issued guidance as to the parameters that any broad subsidy proposal for PD-(L)1 inhibitors (such as Keytruda®) would have to address, noting that it was “supportive of implementing simplified listings for PD-(L)1 inhibitors within a specific tumour type if this would facilitate appropriate and timely access for patients”.
At the July 2025 meeting, PBAC also recommended against PBS listing of Keytruda® for the treatment of primary advanced or recurrent endometrial cancer.