VorasidenibVoranigo
Treatment of patients with WHO Grade 2 IDH-mutant astrocytoma or oligodendroglioma with residual or recurrent disease after at least one prior surgery, who are not in immediate need of radiotherapy or chemotherapy.
Decisions on record
- Meeting Mar 2026 Recommended Astrocytoma or oligodendroglioma isocitrate dehydrogenase-mutant
- Meeting Jul 2025 Not recommended Isocitrate dehydrogenase-mutant astrocytoma or oligodendroglioma
Access path
- TGA registered · Voranigo
TGA label narrower than the PBS population
- Jul 2025Not recommended
vs active surveillance
- ↻ resubmittedMar 2026Recommended · restricted
Comparator changed: active surveillance → active surveillance alone
- PBS listing · Authority Required
From the public summary
7.1 The PBAC did not recommend the listing of vorasidenib for the treatment of IDH- mutant astrocytoma or oligodendroglioma. The PBAC acknowledged the high unmet clinical need for treatments for astrocytoma or oligodendroglioma.PSD · Jul 2025
7.2 The PBAC acknowledged the high unmet clinical need for effective treatments for IDH- mutant astrocytoma or oligodendroglioma, noting that there are currently no other effective treatments available for patients not in immediate need of chemotherapy/radiotherapy.PSD · Jul 2025
6.36 The submission presented a modelled economic evaluation comparing vorasidenib with placebo (as a proxy for active surveillance), for the treatment of patients with Grade 2 IDH-mutant astrocytoma or oligodendroglioma. The economic evaluation was based on the results of the INDIGO trial, with additional modelled data. The economic evaluation was presented as a stepped cost-effectiveness/cost-utility analysis.PSD · Jul 2025
Table 9: Summary of model structure, key inputs and rationale Component Summary Treatments Vorasidenib versus active surveillance Time horizon 40 years in the base case versus a median follow-up of 17.3 months in the INDIGO trial.PSD · Jul 2025
of safety, compared to placebo, as a proxy for active surveillance alone.PSD · Jul 2025
Source: Table 1.1, p2 of the submission; Section 2.7.2, p71 of the submission.PSD · Jul 2025
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
Cost-effectiveness
ICER range redacted. Base case ICER stated as '$2/QALY' with redacted content; the redacted value range is '$95,000 to <$115,000 per QALY'.
Decision context
PopulationAdult patients with WHO Grade 2 IDH-mutant astrocytoma or oligodendroglioma with residual or recurrent disease after at least one prior surgery, ECOG performance score ≤1, not in immediate need of radiotherapy or chemotherapy.
Risk sharingTiered risk sharing arrangement (RSA) proposed including reimbursement of percentage of expenditure exceeding financial caps by up to a specified percentage, with details redacted.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | active surveillance alone | — | RCT · PFS |
| Jul 2025 | Not recommended | active surveillance | — | RCT · PFS |
Consumer voice
Health professionals and individuals emphasized the significant side effects and long-term impacts of current IDH mutant glioma treatments (surgery, radiotherapy, chemotherapy) on cognitive function, independence, and quality of life. They noted vorasidenib's potential to delay disease progression and toxic adjuvant therapies, thereby preserving cognitive function and independence while offering a
These treatments can have immediate impacts on independence (e.g. ability to drive), and result in brain fogginess, nausea/vomiting, constipation and increased infection risk; as well as longer term impacts such as memory loss, reduced cognition (ability to think, problem solve etc), fatigue, infertility, and an inability to work. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to residual/recurrent disease after ≥1 prior surgery; TGA label includes treatment after initial surgery without prior recurrence requirement.