RETIFANLIMAB

The PBAC recommended the listing of retifanlimab for the treatment of Merkel cell carcinoma (MCC, a type of skin cancer) which has spread to another part of the body or recurred and cannot be cured by surgery or radiation. 

The PBAC recalled input from individuals, health care professionals and organisations from its November 2025 consideration, and noted there is an unmet clinical need for treatments of MCC. The PBAC recalled it previously did not accept the sponsor’s claim that retifanlimab is more safe and effective than avelumab for the treatment of MCC but accepted that retifanlimab is as safe and effective as avelumab for MCC. 

The PBAC recalled it previously deferred making a decision on the PBS listing of retifanlimab as it was unknown at the time if the Therapeutic Goods Administration (TGA) would approve the registration of retifanlimab. After receiving confirmation that the TGA was likely to approve retifanlimab, the PBAC recommended listing retifanlimab at a cost no higher than that of a course of treatment of avelumab. 

The PBAC expected that the overall financial cost would increase slightly once retifanlimab was available on the PBS, as retifanlimab would provide access to a small number of extra patients with locally advanced MCC. The PBAC considered that retifanlimab should be included in the existing risk sharing arrangement for MCC. The PBAC considered that 500 mg of retifanlimab every 4 weeks would be equivalent to 800 mg of avelumab every 2 weeks, based on the flat dosing regimens recommended in their respective product information. The PBAC noted that flow on changes to the avelumab PBS listing would be required to include the clinical criterion ‘Patient must be untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at initiation therapy for this condition’.