Ivosidenib plus azacitidine is recommended, within its marketing authorisation, as an option for untreated acute myeloid leukaemia (AML) with an IDH1 R132 mutation in adults who cannot have standard intensive induction chemotherapy. It is only recommended if the company provides it according to the commercial arrangement.
Why the committee made these recommendations
Usual treatment for newly diagnosed AML with an IDH1 R132 mutation in adults who cannot have standard intensive induction chemotherapy is venetoclax plus azacitidine.
Ivosidenib plus azacitidine has not been directly compared in a clinical trial with venetoclax plus azacitidine. An indirect comparison suggests that ivosidenib plus azacitidine increases how long people live and how long they have before their condition gets worse compared with venetoclax plus azacitidine.
The most likely cost-effectiveness estimates for ivosidenib plus azacitidine are within the range that NICE considers an acceptable use of NHS resources. So, it is recommended.