Backlash over PBAC monitoring

The true extent of industry’s unease with the PBAC’s monitoring system of updated overall survival (OS) results of cancer medicines listed on the PBS has been exposed in new documents released to the public.

Yesterday, both the Monitoring system for updated OS results for cancer trials report, conducted by Monash University, and the associated PBAC Minutes, which raises concerns that the system may discourage sponsors from making PBAC submissions or lead to the delisting of medicines, were published.

In June 2024, the Department contracted Monash University to develop a system to monitor final trial OS results for cancer medicines recommended by the PBAC and PBS listed with the aim of highlighting if final trial OS results were consistent, better, or worse than the interim/immature results considered by the PBAC at the time of recommendation for PBS listing, and any issues with publication bias or reasons for results not being available.