The National Institute for Health and Care Excellence (NICE) have approved Novartis' medicine ribociclib, brand name Kisqali▼, for use with another medicine, fulvestrant, for treating hormone receptor-positive, HER2-negative, advanced breast cancer.
This means that patients in England and Wales can be treated with the medicine.
Kisqali, with fulvestrant, is available through the Cancer Drugs Fund. It is a possible option for adults who have locally advanced or metastatic breast cancer that:
- is hormone receptor-positive and human epidermal growth factor 2 (HER2)-negative and
- has been treated with endocrine therapy previously and
- if exemestane plus everolimus would be the most appropriate alternative to a cyclin-dependent kinase 4 and 6 inhibitor
More evidence on ribociclib is being collected, until December 2020. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.
You can follow developments with Kisqali by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.
Why NICE made these recommendations
During technical engagement it was agreed that the appraisal will focus on people whose disease has progressed up to 12 months after initial treatment for the cancer with endocrine therapy or after 1 line of endocrine therapy for advanced disease. The main alternative for this population is another pair of medicines, exemestane with everolimus.
Clinical trial evidence suggests that, compared with fulvestrant alone, ribociclib with fulvestrant increases the length of time before the disease progresses in people who have had previous endocrine treatment. It's not known whether ribociclib increases the length of time people live because the final trial results are not available yet. The results of an indirect comparison of ribociclib and fulvestrant with exemestane and everolimus are very uncertain.
The cost-effectiveness estimates are also very uncertain, and are above the range NICE normally considers an acceptable use of NHS resources. Therefore, ribociclib with fulvestrant cannot be recommended for routine use in the NHS.
Ribociclib with fulvestrant has the potential to be cost effective for the population considered in this appraisal, but more data are needed to resolve the uncertainties in the clinical evidence. Therefore, ribociclib with fulvestrant is recommended for this population in the Cancer Drugs Fund while these data are collected.
About Kisqali (source EMA)
Kisqali is a cancer medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women.
Kisqali can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative). Kisqali is used with an aromatase inhibitor (a cancer medicine that reduces oestrogen).
The active substance in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important for regulating the way cells grow and divide. By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.
Kisqali was first made available in the EU in 2017. It is manufactured by Novartis.
European Medicines Agency website page for Kisqali
Links available in External Resources
© NICE 
Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative, advanced breast cancer. Technology appraisal guidance [TA593]. Published date: 14 August 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
The information provided by NICE was accurate at the time this article was issued.
NICE information on Kisqali
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