18 August 2023 - In September 2021, the Department of Health and Aged Care contracted the Medicines Intelligence Centre for Research Excellence (MI-CRE) to complete a two-stage research project to: ‘Investigate how overall survival (OS) estimated in patients taking certain PBS-listed cancer medicines in Australia compares to the OS of patients taking the same medicines reported in the pivotal trials included in sponsor submissions to the Pharmaceutical Benefits Advisory Committee (PBAC).’

The MI-CRE’s final report was provided to the PBAC for consideration in May 2022.

The final report showed that 50% (247 out of 498) of PBAC submissions (including resubmissions) for cancer medicines between January 2012 and May 2022, were based primarily on a surrogate outcome. Forty-four per cent of these were not recommended for PBS-listing by the PBAC, and in 62% (67 out of 108) of cases this was due to immature overall survival data. In submissions that presented modelled economic evaluations, surrogate outcomes were used in 85% (140 out of 165) of cases.

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