New Guidance Released on Broad Cancer Medicine Listings for PD-(L)1 Inhibitors
23 Jun 2026
Australian Government Department of Health, Disability and Ageing has released a fact sheet titled “Principles for broad (multi-cancer) listings for programmed cell death-1/programmed death ligand-1 (PD-(L)1) inhibitors”. The document outlines how pharmaceutical companies can seek wider listings for these immunotherapy medicines.
The guidance is intended for sponsors of PD-(L)1 inhibitors who may apply for a broad listing on the Pharmaceutical Benefits Scheme rather than applying for individual cancer indications.
Under the framework, sponsors are not required to apply for broad listings and may still submit applications for specific cancer types under existing procedures.
However, companies seeking a broad listing must first demonstrate strong evidence of safety, effectiveness, and cost-effectiveness across multiple advanced and metastatic cancer settings where the medicine is already listed.
The process involves an initial review of summarised clinical evidence by the Pharmaceutical Benefits Advisory Committee before a formal submission is made. If sufficient evidence is confirmed, sponsors are then invited to provide full economic and financial data.
The Department has advised that sponsors should review the new guidance carefully before submitting applications, as the process differs from standard medicine listing submissions.
New Guidance Released on Broad Cancer Medicine Listings for PD-(L)1 Inhibitors
Source: Australian Government Department of Health, Disability and Ageing – PBAC listing guidance