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NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.
Published on April 10, 2019, the National Institute of Health and Care Excellence (NICE) has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.
The draft guidance, which is now subject to a consultation period until May 9, 2019, summarizes all considered evidence and sets out the recommendations of NICE that ribociclib does not provide a cost-effective option for use in the National Health Service (NHS) and as such is not suitable for use within the Cancer Drugs Fund. Once the consultation period has concluded, the committee will meet again to consider all evidence and comments from consultees as well as the public, after which, the final appraisal document will then be prepared.
Within the guidance document, NICE revealed that the recommendations were made as the final trial results assessing whether ribociclib increases the length of time before disease progression are not yet available. Additionally, the estimated cost-effectiveness of the treatment is not within the usual range accepted by NICE for treatments used within the NHS.
As stated in the guidance document, “The clinical effectiveness and cost-effectiveness estimates are highly uncertain. Also, the cost-effectiveness estimates are much higher than the range NICE normally considers an acceptable use of NHS resources.”
However, it is noted that several uncertainties concerning the clinical trial evidence raised in the guidance may be addressed if further data are collected. Yet, NICE also remarked that at the current pricing of the treatment, it is unlikely that it will found to be cost-effective.