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: in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.
Addition of ivosidenib to azacitidine improved event-free and overall survival in untreated adults with newly diagnosed AML and IDH1 R132 mutation who were ineligible for intensive induction chemotherapy.
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.
Medicine details
- Medicine name:
- ivosidenib (Tibsovo)
- SMC ID:
- SMC2615
- Indication:
In combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.
- Pharmaceutical company
- Servier Laboratories Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 11 March 2024