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New HTA Decisions in England
March 2021
Drug name
KISQALI® (ribociclib)
Company
Novartis
Decision date
26/02/2021
Therapeutic area
Cancer
Therapeutic sub area
Breast cancer
Decision
Recommended with restrictions
Indication
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.
Decision Detail
It is recommended 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 (there is a simple discount patient access scheme for ribociclib).
Summary
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. MONALEESA 3 is a multicentre, double-blind, randomised placebo-controlled trial comparing ribociclib plus fulvestrant against placebo plus fulvestrant in 726 postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer. The committee concluded that ribociclib plus fulvestrant improves progression-free survival and overall survival, compared with placebo plus fulvestrant. However, it noted that the most relevant comparator is exemestane plus everolimus but this was not the comparator in the trial. 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. ICERs are presented as commercial in confidence to maintain the confidentiality of the patient access scheme for ribociclib and everolimus and the commercial arrangement for fulvestrant, therefore, they cannot be reported here.