NICE has approved ribociclib with fulvestrant for use within the Cancer Drugs Fund as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine therapy, and if exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor.
The decision is based on evidence from the multicentre double-blind, randomised, placebo-controlled MONALEESA-3 trial which compared ribociclib and fulvestrant with fulvestrant alone in this population. It enrolled 726 postmenopausal women, and results were presented separately for a subgroup of patients (n=345) who had had previous endocrine therapy.
In the whole trial population, which included patients who had not had previous endocrine therapy, ribociclib with fulvestrant increased median progression-free survival compared with fulvestrant alone (12.8 months vs 20.5 months; hazard ratio [HR] 0.593; 95% CI 0.480-0.732). Similar results were found for the subgroup who had had previous endocrine therapy (HR 0.565; 95% CI 0.428-0.802). At the time of the analysis, overall survival data were immature.
Because there was no evidence directly comparing ribociclib and fulvestrant with exemestane and everolimus, a meta-analysis of six studies was conducted, but the appraisal committee concluded that the results of the meta-analysis were highly uncertain. Hence, the cost-effectiveness estimates were also considered to be very uncertain.
NICE concluded that the treatment has the potential to be cost-effective but more data are needed to resolve the uncertainties in the clinical evidence. Therefore, it has approved ribociclib with fulvestrant for use within the Cancer Drugs Fund while additional data are collected.
Subject to appeal, NICE’s final guidance will be published next month.