What has SMC said?

The Scottish Medicines Consortium (SMC) has accepted ivosidenib to be used together with a type of chemotherapy medicine called azacitidine, for treating adult patients with acute myeloid leukaemia (AML). For use when:

  • the cancer is newly diagnosed, and
  • the patient’s cancer cells have a mutation called R132 in the gene that makes a protein called IDH1, and
  • the patient cannot be treated with standard chemotherapy.

This document summarises the SMC decision and what it means for patients.

You can find more detailed information about the SMC assessment of ivosidenib by looking at the SMC Detailed Advice Document (SMC2615).

What does SMC's decision mean for patients?

Ivosidenib is available for prescribing on the NHS in Scotland.

Your healthcare professional can discuss with you if it is the right treatment for you.

You can find more information about making decisions about your treatment in this booklet called: Medicines in Scotland: What’s the right treatment for me?

More about SMC’s decision

SMC’s decision takes into account a confidential discount offered by the pharmaceutical company. SMC was also able to be more flexible* in its decision-making because the medicine is for:

  • A rare condition, and
  • A condition where patients taking current treatments are likely to live less than 3 years. 

How does SMC make its decision?

SMC carefully considers every new medicine to make sure it benefits patients and is likely to be a good use of NHS resources.

To do this SMC studies the following:

  • Evidence from the company about how well the medicine works compared with current treatments available in Scotland, in relation to how much they will cost to buy and use to treat patients.
  • Information from patient groups about the potential impact of the medicine on patients and carers.
  • Advice from healthcare professionals about any benefits of the new medicine compared to current treatment, along with how the new medicine is likely to be used.

When SMC assesses a medicine it takes account of the needs of all patients in NHSScotland, not only those who may be treated with the medicine.

You can find out more about how SMC decides here: htps://www.scottishmedicines.org.uk/how-we-decide/

More information and support

The organisations below can provide more information and support for people with leukaemia and their families. SMC is not responsible for the content of any information provided by external organisations.

Blood Cancer UK
https://bloodcancer.org.uk
0808 2080 888

Leukaemia Care
https://www.leukaemiacare.org.uk
0808 8010 444

You can find out more about ivosidenib (Tibsovo®) in the Patient Information Leaflet (PIL) by searching for the medicine name on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
https://products.mhra.gov.uk/          

Date advice published: 11 March 2024
SMC ID: SMC2615