Vorasidenib (Voranigo)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Voranigo be reimbursed by public drug plans for patients aged 12 years and older with grade 2 (WHO 2016, 2021 grading system) astrocytoma or oligodendroglioma with a susceptible IDH1 mutation or IDH2 mutation who are not in immediate need of radiotherapy and/or chemotherapy following surgical intervention if certain conditions are met.
• The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Voranigo demonstrates acceptable clinical value compared with active surveillance in patients with grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations. This determination was sufficient for pERC to recommend that Voranigo be reimbursed. Given that Voranigo is expected to be an additive treatment to active surveillance, acceptable clinical value refers to added value versus active surveillance.
• Evidence from a clinical trial (INDIGO; N = 331) demonstrated that, when compared to active surveillance, treatment with Voranigo likely resulted in added clinical benefit in progression-free survival (PFS) and time to next intervention (TTNI) in patients aged 12 years and older with grade 2 oligodendroglioma or astrocytoma with a susceptible IDH1 or IDH2 mutation who were not in immediate need of radiotherapy and/or chemotherapy.
• Key limitations of the evidence were the short duration of follow-up, which prevented pERC from drawing conclusions on the impact of Voranigo on overall survival (OS), and the large amount of missing data for health-related quality of life (HRQoL) outcomes.The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
• Voranigo should only be covered for patients aged 12 years and older with grade 2 (WHO 2016, 2021 grading system) astrocytoma or oligodendroglioma with a susceptible IDH1 mutation or IDH2 mutation who have had at least 1 prior surgery for glioma, have measurable and/or evaluable disease at the time of initiation of therapy, and are not in immediate need of radiotherapy or chemotherapy, in line with the sponsor’s reimbursement request. Patients should also have good performance status and must not have grade 3 tumours or tumours with high-risk features, prior anticancer therapy for glioma other than surgery, or current therapeutic steroid use for glioma.