NICE approves ribociclib with fulvestrant for breast cancer

Woman having breast cancer tests sat on hospital bed, surrounded by equipment with a doctor to show More than 350 genetic 'errors' identified in major study of the genetics of breast cancer

Patients to have a further drug combination option on Cancer Drugs Fund as NICE approves ribociclib with fulvestrant for breast cancer in draft guidance.

The positive recommendation follows an improved patient access scheme by the company as part of a commercial arrangement.

The draft guidance recommends ribociclib (also called Kisqali and made by Novartis) with fulvestrant as an option for people with hormone receptor-positive, human epidermal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.

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.

NICE has already approved abemaciclib (also a CDK4/6 inhibitor) used with fulvestrant for the same indication within the Cancer Drugs Fund.

The committee heard from patients that they value improvements in progression-free survival and want to delay chemotherapy for as long as possible. They also heard that the different side effects of each of the CDK4/6 inhibitors mean that people would like to have a range of treatment options available to them.

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.”

Ribociclib with fulvestrant will be available to NHS patients in England immediately. Subject to appeal, NICE’s final guidance will be published August.