18 July 2019

The National Institute for Health and Care Excellence (NICE) has today (17 July 2019) announced its decision to approve ribociclib in combination with hormone therapy fulvestrant for NHS use in England via the Cancer Drugs Fund. 

This combination will offer a new treatment option for patients with hormone receptor positive, HER2 negative locally-advanced or metastatic breast cancer after prior hormone therapy.

Ribociclib (Kisqali, Novartis) is one of a new class of drugs known as CDK4/6 inhibitors, which work by targeting two crucial cell division proteins called CDK4 and CDK6. Another similar drug called abemaciclib is already available in combination with fulvestrant on the Cancer Drugs Fund (CDF) for treating this patient group, and today’s decision will now see a second option made available to patients and their doctors.

For patients who have received prior hormone therapy, a major trial (MONALEESA-3) has shown that giving ribociclib in combination with fulvestrant extends the time before a patient’s disease progresses (progression-free survival) by 7.7 months on average, compared to fulvestrant alone. Overall survival data from the trial is not yet mature, so it is not yet known whether this treatment will extend patients’ lives overall.

It is estimated that up to 5,300 patients who have already had hormone therapy could now be eligible for this option via the Cancer Drugs Fund. The CDF enables NICE to conditionally approve promising treatments whilst more data is collected. Following this period of data collection, NICE will reconsider the treatment and make a final decision on its use on the NHS.

Ribociclib is already recommended by NICE for use in combination with an aromatase inhibitor for patients with previously untreated hormone positive, HER2 negative locally-advanced or metastatic breast cancer.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Care and Breast Cancer Now, said: 

“It’s wonderful news that ribociclib with fulvestrant will now be available to thousands of people living with incurable breast cancer who have already had hormone therapy.

“Compared with fulvestrant alone, this combination treatment can offer patients invaluable extra time before their disease progresses – time to live well and continue with day-to-day activities such as working for as long as possible. This option could also help delay the need for chemotherapy and the debilitating side effects it can bring. 

“The addition of ribociclib to NHS care, alongside similar drug abemaciclib, will now improve patient choice and help give them more control over their quality of life. These options are just as effective but can come with different side effects, so it’s now vital that all patients are supported to make the decision that’s right for them.

“We’re pleased to see that Novartis, NHS England and NICE have worked together to ensure patients who have already had hormone therapy can access this important option while further data on its full benefits are collected.1 We hope NICE will be able to approve this combination for routine use following its time on the Cancer Drugs Fund and look forward to further trial results to understand whether this treatment will also extend patients’ lives overall.”

Notes to Editors

1 The Cancer Drugs Fund provides access to patients in England, but drugs on the fund also benefit patients in Wales and Northern Ireland. In Wales, drugs on the CDF are covered by the New Treatment Fund and the Northern Ireland Department of Health now also provides access to drugs recommended for use on the CDF. The Scottish Medicines Consortium (SMC) is due to assess ribociclib with fulvestrant for use on the NHS in Scotland later this year.