NICE decision on ribociclib with fulvestrant for breast cancer


  • Dawn O'Shea
  • Oncology drug update
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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 but only if exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor.

During the appraisal process, it was agreed that the appraisal will focus on people whose disease has progressed up to 12 months after neoadjuvant or adjuvant endocrine therapy or after 1 line of endocrine therapy for advanced disease. The main alternative for this population is exemestane with everolimus.

The decision is based on findings from the multicentre double-blind randomised placebo-controlled MONALEESA‑3 trial comparing ribociclib and fulvestrant with placebo and fulvestrant, in people who have had previous endocrine treatment. The study reported increased progression-free survival, but the effect on overall survival was uncertain.

As a result, the cost-effectiveness estimates were also uncertain, and are above the range NICE normally limit. However, the NICE appraisal committee acknowledged that the combination has the potential to be cost-effective, and recommended that the treatment be made available through the Cancer Drugs Fund while more mature data are collected.

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