The National Institute of Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative.
The decision comes just three months after the governing body issued a draft guidance rejecting the drug, citing that “it is not known whether Kisqali increases the length of time people live, because the final trial results are not available yet. Because of the uncertainties in the clinical evidence, and cost-effectiveness estimates that are much higher than NICE normally considers to be an acceptable use of NHS resources, Kisqali with fulvestrant cannot be recommended for routine use in the NHS.”
The decision was made despite clinical trial evidence suggesting that compared with fulvestrant alone, the Kisqali combination increases the length of time before the disease progresses in people with previously untreated advanced disease and in people after a prior endocrine treatment.
After the revised decision, the combination treatment will be available on the NHS with immediate effect, providing approximately 5,300 a year in England and Wales with a new option for their advanced breast cancer.
The recommendation is based on the second line subpopulation of the MONALEESA-3 trial, in which the combination demonstrated a median progression-free survival (PFS) of 14.6 months vs the placebo plus fulvestrant at 9.1 months.
Novartis is awaiting the NICE Technology Appraisal Guidance, the final step within the NICE approval process, which is scheduled for publication later this year and will be available via the NICE website. There will be immediate access to the combination treatment in England through the Cancer Drugs Fund (CDF) and in Wales through the Welsh New Treatment Fund, whilst Novartis await the NICE Technology Appraisal.
In the UK, around 55,000 women are diagnosed with breast cancer each year. 30% of women with earlier stages of breast cancer will develop advanced disease and 85% of women diagnosed with metastatic breast cancer, where the cancer has spread beyond the breast, will not live longer than five years.