What has SMC said?
The Scottish Medicines Consortium (SMC) has accepted ivosidenib for the treatment of adults with cholangiocarcinoma (cancer of the bile duct) that is locally advanced (has spread nearby from where it started) or metastatic (has spread to other parts of the body), where the cancer cells have a genetic change called an IDH1 R132 mutation and where the patient has received at least one previous line of treatment.
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 (SMC2669).
What does SMC’s decision mean for patients?
Ivosidenib for use as described above 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 organisation below can provide more information and support for people with cancer of the bile duct their families. SMC is not responsible for the content of any information provided by external organisations.
AMMF – The Cholangiocarcinoma Charity
https://ammf.org.uk 01279 661479
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.