VorasidenibVoranigo

5.1 The PBAC recommended the listing of vorasidenib for the treatment of isocitrate dehydrogenase-mutant (IDH) astrocytoma or oligodendroglioma. The PBAC maintained its view that there is a high unmet clinical need for effective treatments for astrocytoma and oligodendroglioma, noting that there are currently no other effective treatments available for patients not in immediate need of chemotherapy/radiotherapy.PSD · Mar 2026

However, vorasidenib was considered acceptably cost-effective at the reduced price proposed in the resubmission and the revised financial estimates were considered reasonable. The PBAC advised that amendments 23 OFFICIALPSD · Mar 2026

4.17 At the July 2025 meeting, the PBAC considered that a more reasonable base case would:PSD · Mar 2026

• incorporate more conservative assumptions regarding PFS/OS (Weibull extrapolation function for PFS) and utility values (as per dabrafenib + trametinib submission, March 2024 PBAC meeting). 9 OFFICIALPSD · Mar 2026

of safety, compared to placebo, as a proxy for active surveillance alone.PSD · Mar 2026

Source: Table 1.1, p2 of the July 2025 submission; Section 2.7.2, p71 of the July 2025 submission.PSD · Mar 2026

6.3 The comments from health professionals described the current treatment options for IDH mutant gliomas as surgery, radiotherapy and chemotherapy. These treatments can have immediate impacts on independence (e.g.PSD · Jul 2025

The comments noted that vorasidenib provides a more palatable option with less short-term and long-term impacts on patient wellbeing. Comments from one health professional indicated that given these benefits there may be patients who should be having radiotherapy and chemotherapy, but would seek to have lower toxicity vorasidenib, despite this not being an evidence-based approach to use of the drug.PSD · Jul 2025