ivosidenib (Tibsovo)

following a full submission assessed under the end of life and orphan medicine process

ivosidenib (Tibsovo®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who were previously treated by at least one prior line of systemic therapy.

In a double-blind, phase III study, ivosidenib, compared with placebo, significantly improved progression-free survival in adults with locally advanced or metastatic cholangiocarcinoma with IDH1 mutation who were previously treated by one or two prior lines of systemic therapy for advanced disease.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.