2 Information about ivosidenib with azacitidine

Marketing authorisation indication

2.1

Ivosidenib (Tibsovo, Servier Laboratories) 'in combination with azacitidine is indicated 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'.

Dosage in the marketing authorisation

Price

2.3

The list price of a 60‑tablet pack of 250 mg ivosidenib is £12,500, or £150,000 for a year of treatment (excluding VAT; BNF online accessed January 2024). At the time of evaluation, the average price of azacitidine was £45.16 per 100 mg powder for suspension for injection vial (excluding VAT; eMIT accessed September 2023).

2.4

The company has a commercial arrangement. This makes ivosidenib available to the NHS with a discount. The size of the discount is commercial in confidence.