l

The content of this website is intended for healthcare professionals only

Further advanced breast cancer drug combo available on CDF

NICE gives provisional thumbs up to ribociclib plus fulvestrant for advanced disease

Caroline White

Wednesday, 17 July 2019

Another drug combination for women with advanced breast cancer is set to become available on the Cancer Drugs Fund (CDF) after being given the green light by the National Institute for Health and Care Excellence (NICE) in draft guidance published today.

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

The draft guidance recommends ribociclib (Kisqali and made by Novartis) with fulvestrant as an option for people with hormone receptor-positive, human epidermal growth factor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

Taken once daily as a pill, ribociclib is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. These drugs work by blocking the production of proteins in cancer cells, thereby preventing them from dividing and growing.

The newly approved combo could be an option for up to 5,300 women for whom 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) plus 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, the addition of ribociclib postpones progression. But it’s not known whether ribociclib increases survival, because the final trial results are not yet available.

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 in August.

Registered in England and Wales. Reg No. 2530185. c/o Wilmington plc, 5th Floor, 10 Whitechapel High Street, London E1 8QS. Reg No. 30158470