Ivosidenib is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation in adults after 1 or more systemic treatments. It is only recommended if the company provides it according to the commercial arrangement.
Why the committee made these recommendations
Usual treatment for locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation after systemic treatment is modified folinic acid plus fluorouracil and oxaliplatin (mFOLFOX), and best supportive care to manage symptoms.
Clinical trial evidence shows that ivosidenib increases how long people live and how long they have before their cancer gets worse compared with placebo.
Ivosidenib has not been directly compared with mFOLFOX in a clinical trial. An indirect comparison suggests that ivosidenib increases how long people live compared with mFOLFOX.
There is a considerable unmet need for treatments for locally advanced or metastatic cholangiocarcinoma. When considering the condition's severity, 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, ivosidenib is recommended.