IvosidenibTibsovo

5.1 The PBAC recommended ivosidenib, for treatment of locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, in patients who have previously progressed on chemotherapy. The PBAC considered that there was a high clinical need for treatments for patients with locally advanced or metastatic cholangiocarcinoma, who have a very poor prognosis.PSD · Nov 2024

5.2 The PBAC considered that the proposed restriction criteria were appropriate but that a combined listing including initial, continuing and grandfather treatment would be preferred for simplicity.PSD · Nov 2024

4.7 To address the PBAC’s concerns regarding the cost-effectiveness of ivosidenib the resubmission presented an economic evaluation with revised inputs for the time horizon and overall survival extrapolation functions and a reduced price for ivosidenib (% reduction, from $ to $ AEMP). The base case incremental cost-effectiveness ratio (ICER) in the resubmission was $55,000 to < $75,000 per quality-adjusted life year (QALY).PSD · Nov 2024

4.8 The resubmission did not fully revise the model as requested by the PBAC:PSD · Nov 2024

testing and untargeted treatment/palliative care in patients with locally advanced or metastatic CCA.PSD · Nov 2024

Source: Table 1-2, p31 of the July 2024 submission For more detail on PBAC’s view, see section 5 PBAC outcome.PSD · Nov 2024

4.2 The PBAC noted and welcomed the input from individual (12), and organisational (5) contributors via the Consumer Comments facility on the PBS website. The PBAC also recalled consumer comments received in relation to the July 2024 consideration of ivosidenib.PSD · Nov 2024

4.3 The PBAC noted the advice received from Pancare Foundation, Liver Foundation and Cholangiocarcinoma Foundation Australia in support of the ivosidenib submission.PSD · Nov 2024