This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo
News

NICE decision on ribociclib with fulvestrant for breast cancer

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.


References


YOU MAY ALSO LIKE