NICE (UK) positive for Voranigo (vorasidenib) for treating astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations after surgery in people 12 years and over – Servier

NICE(UK): Vorasidenib can be used as an option to treat grade 2 astrocytoma or oligodendroglioma in people 12 years and over when: i) the cancer has a susceptible isocitrate dehydrogenase (IDH) 1 or IDH2 mutation; ii) the person has had surgery and does not immediately need chemotherapy or radiotherapy; and iii) the company provides vorasidenib according to the commercial arrangement. Stop vorasidenib if the cancer progresses and in line with the stopping criteria in the marketing authorisation. This recommendation is not intended to affect treatment with vorasidenib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

Why the committee made these recommendations: Usual care for grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 mutation for people whose cancer has not progressed (got worse) and who do not immediately need chemotherapy or radiotherapy after surgery is active surveillance. This evaluation included a rule that vorasidenib is stopped if the cancer gets worse. This rule was used in the main clinical trial and is in line with how vorasidenib would be used in practice, but is not part of the marketing authorisation for vorasidenib. Clinical trial evidence shows that vorasidenib increases how long people have before their cancer gets worse compared with placebo. But it is uncertain whether vorasidenib affects how long people live. The cost-effectiveness estimates for vorasidenib are uncertain. But there are several benefits of vorasidenib that have not been fully captured in the economic model. When considering these, and the severity of the condition and its effect on quality and length of life, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, vorasidenib can be used.