The Committee deems that the clinical benefit of TIBSOVO (ivosidenib) 250 mg, film-coated tablet, is moderate only for adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation whose disease has progressed after least one line of systemic treatment and who are ineligible for FOLFOX chemotherapy.
Insufficient
The Committee deems that the clinical benefit of TIBSOVO (ivosidenib) 250 mg, film-coated tablet, is insufficient in other contexts to justify public funding.
Clinical Added Value
minor
Within the reimbursement scope:
In view of:
the evidence of superiority of TIBSOVO (ivosidenib) versus placebo in terms of progression-free survival (HR = 0.37 CI95%: [0.25; 0.54], p <0.0001), with an absolute difference in the medians of 1.3 months in a randomised double-blind phase III study;
and despite:
the modest deemed gain on this outcome measure and the lack of evidence on a gain in overall survival;
a toxicity profile marked by severe AEs observed in 35% of the patients of the ivosidenib group and in 23.7% of the patients in the placebo group, and a risk of QT interval prolongation;
the lack of evidence of an improvement in quality of life;
the inability to define the precise place of this treatment in relation to the FOLFOX regimen in the absence of robust comparative data;
the Committee deems that TIBSOVO (ivosidenib) 250 mg, film-coated tablet, provides minor clinical added value (CAV IV) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation whose disease has progressed after least one line of systemic treatment and who are ineligible for FOLFOX chemotherapy.
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