1 Recommendations

1.1 Ribociclib with fulvestrant is not recommended, within its marketing authorisation, for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy, or in people who have had previous endocrine therapy.

1.2 This recommendation is not intended to affect treatment with ribociclib with fulvestrant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

During technical engagement it was agreed that the appraisal will focus on people whose disease has progressed at or within 12 months after neoadjuvant endocrine therapy, and disease that has progressed after 1 line of endocrine therapy in an advanced setting and that the key comparator for this population is 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 with either untreated advanced disease or in those who have had a prior endocrine treatment. It is not known whether ribociclib increases the length of time people live because the final trial results are not available yet. An indirect comparison was conducted to compare ribociclib and fulvestrant with exemestane and everolimus.

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. Therefore, ribociclib with fulvestrant cannot be recommended for routine use in the NHS.

There are several uncertainties with the clinical trial evidence, which may be addressed if more data are collected. However, ribociclib with fulvestrant does not have plausible potential to be cost effective at the offered price. Therefore, ribociclib with fulvestrant cannot be recommended for use within the Cancer Drugs Fund.