The Department has published a fact sheet ‘Principles for broad (multi-cancer) listings for programmed cell death-1/programmed death ligand-1 (PD-(L)1) inhibitors’. This document is intended to outline the guiding principles for sponsors who may be seeking a broad (multi-cancer) listing for PD-(L)1 inhibitors.
Sponsors of PD-L(1) medicines are not required to seek a broad listing. Sponsors retain the ability to lodge submissions seeking PBS listings for specific indications in accordance with the Procedure guidance for listing medicines on the PBS and PBAC Guidelines.
Sponsors seeking a broad listing for their PD-(L)1 inhibitor would need to have previously demonstrated efficacy, safety and cost-effectiveness in the advanced and metastatic settings resulting in PBS listings in a range of indications across different tumour types. An application for a broad listing would then be suitable for PBAC consideration.
Sponsors are encouraged to review the guidance before submitting to PBAC as the approach is different to standard submissions. For broad listing requests, sponsors are requested to first provide their summarised clinical evidence to PBAC@health.gov.au prior to submitting a formal submission. The Department will then progress the summarised clinical evidence to the PBAC to review at the next available meeting. If the PBAC determines it is confident there is sufficient clinical evidence to substantiate use in a broad listing setting, the Department will work with individual sponsors to facilitate submission of economic and financial evidence information via a formal submission.
Questions regarding broad listings should be directed to PBAC@health.gov.au