1 Recommendations

1 Recommendations

1.1 Ribociclib plus fulvestrant is recommended as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults 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 company provides ribociclib according to the commercial arrangement.

Why the committee made these recommendations

This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for ribociclib plus fulvestrant for hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine (hormone) therapy.

The new evidence includes data from patients in clinical trials and from patients having treatment in the NHS, while this treatment was available in the Cancer Drugs Fund in England. It suggests that, compared with fulvestrant alone, people taking ribociclib plus fulvestrant have longer before their disease progresses and live longer.

Ribociclib is a CDK 4/6 inhibitor. Another treatment option is exemestane plus everolimus, which is a hormone therapy. There are no trials directly comparing ribociclib plus fulvestrant against exemestane plus everolimus. But an indirect comparison suggests that ribociclib plus fulvestrant may be the more effective option for people who have already had hormone therapy.

There are uncertainties about the economic modelling. But the base-case results and most of the exploratory analyses suggest that ribociclib plus fulvestrant is a cost-effective alternative to exemestane plus everolimus. So, ribociclib plus fulvestrant is recommended only if exemestane plus everolimus is the most appropriate alternative to a CDK 4/6 inhibitor.

  • National Institute for Health and Care Excellence (NICE)