The draft guidance recommends ribociclib (also called Kisqali and made by Novartis) used with fulvestrant as an option for people with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer who have had previous endocrine therapy.
The positive recommendation follows an improved patient access scheme by the company as part of a commercial arrangement.
Clinical trial evidence suggests that, compared with fulvestrant alone, ribociclib with fulvestrant increases the length of time before the disease progresses. However, it is not known whether ribociclib increases the length of time people live, because the final trial results are not available yet.
The committee recognised that ribociclib with fulvestrant has the potential to be cost-effective, and therefore recommended it for use on the CDF. This will allow more evidence to be collected to address the uncertainties around overall survival and cost-effectiveness.
Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said: “Treatments that can postpone disease progression are important because they can reduce the number of people who are exposed to the often unpleasant side-effects of chemotherapy, and delay the need for its use in others.
“We are pleased therefore that the company has agreed a commercial arrangement for ribociclib that will allow it to be made available to people with this type of breast cancer.”
Taken once-daily in pill form, ribociclib is a type of drug called a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. These work by inhibiting proteins in cancer cells, thereby preventing the cells from dividing and growing.
The treatment could be an option for up to 5,300 women who have already had endocrine treatment and where exemestane plus everolimus would be the most appropriate alternative to a CDK 4/6 inhibitor.