What has SMC said?
The Scottish Medicines Consortium (SMC) has not recommended inavolisib used together with the medicines palbociclib and fulvestrant to treat adults with breast cancer that is locally advanced (spread to nearby tissues) or metastatic (has spread to other parts of the body), where the breast cancer has hormone receptors (is hormone receptor-positive), does not have a protein called HER2 (is HER2-negative) and has an alteration in the PIK3CA gene. For use when the cancer has come back during or within 12 months of hormonal treatment given after surgery to help stop the cancer coming back (hormonal adjuvant treatment).
This document summarises the SMC decision and what it means for patients.
You can find more detailed information about the SMC assessment of inavolisib by looking at the SMC Detailed Advice Document (SMC2902).
What does SMC’s decision mean for patients?
Inavolisib for use as described above should not normally be prescribed on the NHS in Scotland. Your healthcare professional should talk with you about other treatment options.
If your healthcare professional thinks you would benefit from it, they can make a request to prescribe inavolisib. All health boards have procedures in place to consider these requests.
You can find more information about making decisions about your treatment here: Medicines in Scotland: What’s the right treatment for me?
More about SMC’s decision
SMC was unable to accept inavolisib as described above for routine use. The evidence from the company about the benefits the medicine offers when compared to current treatments was not strong enough to justify the additional cost of the medicine. In addition, the company's evidence of the medicine’s value for money was not strong enough. This was despite using a more flexible approach* in the assessment as it is for a rare 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: https://www.scottishmedicines.org.uk/how-we-decide/
More information and support
The organisations below can provide more information and support for people living with breast cancer and their families. SMC is not responsible for the content of any information provided by external organisations.
Breast Cancer Now
https://breastcancernow.org 0808 800 6000
METUP UK
https://metupuk.org.uk
Make 2nds Count
https://make2ndscount.co.uk
You can find out more about inavolisib (brand name: Itovebi®) 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/