1.1 Ribociclib with fulvestrant is recommended 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 only if:
exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor and
the conditions in the managed access agreement for ribociclib with fulvestrant are followed.
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 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.
Clinical trial evidence suggests that, compared with fulvestrant alone, ribociclib with fulvestrant increases the length of time before the disease progresses in people who have had previous endocrine treatment. It's not known whether ribociclib increases the length of time people live because the final trial results are not available yet. The results of an indirect comparison of ribociclib and fulvestrant with exemestane and everolimus are very uncertain.
The cost-effectiveness estimates are also very uncertain, and are above the range NICE normally considers an acceptable use of NHS resources. Therefore, ribociclib with fulvestrant cannot be recommended for routine use in the NHS.
Ribociclib with fulvestrant has the potential to be cost effective for the population considered in this appraisal, but more data are needed to resolve the uncertainties in the clinical evidence. Therefore, ribociclib with fulvestrant is recommended for this population in the Cancer Drugs Fund while these data are collected.