In a significant breakthrough, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) has recommended a broad, multi-indication listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers. The novel recommendation is the result of development work by BMS and the Department of Health, Disability and Ageing to overcome previous concerns with broad listings of this type.
The proposal includes a risk-sharing arrangement and is supported by consumer and clinical representative bodies. The recommended listing would allow clinicians to apply clinical judgment and discretion in using the medicines according to the best available evidence at the time, including for rare cancers for which regulatory submissions are unlikely. The listing would also remove the once in a lifetime limitation for these medicines when used for advanced or metastatic cancers. The PBAC hopes this approach may serve as a framework for future, similar proposals of this kind. It asked that the listing be reviewed after three years to ensure the use remained consistent with its intention.
The PBAC’s recommendation comes just two months after it rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in advanced or metastatic cancers. In that case, 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.”
At least Amgen, Sandoz, Xbrane/Intas, Enzene and Reliance Life Sciences have nivolumab biosimilars in development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024. In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for an ipilimumab biosimilar.