The National Institute for Health and Care Excellence (NICE) has today (10 April 2019) provisionally rejected breast cancer drug ribociclib in combination with fulvestrant for use on the NHS in new draft guidance. 

Trials have shown the combination could offer an additional treatment option for patients with hormone receptor positive, HER2 negative locally-advanced or metastatic breast cancer after prior endocrine therapy

Ribociclib (Kisqali, Novartis) is one of a class of drugs known as CDK4/6 inhibitors, which work by targeting two crucial cell division proteins, CDK4 and CDK6. Abemaciclib, another drug in this class, was last week approved in combination with fulvestrant for use on the Cancer Drugs Fund.

Abemaciclib, ribociclib and palbociclib have all previously been approved for routine NHS use in combination with an aromatase inhibitor for patients with previously-untreated hormone positive, HER2-negative locally-advanced or metastatic breast cancer. 

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 condition progresses (known as 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 the progression-free extension may also translate into life extension.

NICE’s draft guidance sets out that the committee was unable to recommend this treatment  due to uncertainties with the clinical and cost-effectiveness estimates. Whilst some of the clinical uncertainties could be addressed with further data collection, NICE said that the cost-effectiveness estimates are currently much higher than would normally be considered an acceptable use of NHS resources. 

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

It is deeply disappointing that NICE has been unable to approve ribociclib with fulvestrant, which could provide a vital additional option to thousands of patients who have had prior hormone therapy. 

While a similar treatment is already available, it’s unacceptable that this outcome could unnecessarily limit patient choice and we need all parties to work together to find a solution.

Ribociclib and fulvestrant can offer patients precious extra months before their disease gets worse and comes with different side effects to other CDK 4/6 inhibitors which some patients may find more tolerable. Having this option available to patients and their doctors could be so important in giving them greater control over their quality of life

We now urge Novartis, NICE and NHS England to do all they can to ensure this treatment option can be made available to patients at a price the NHS can afford.

On the process that has seen a draft rejection of ribociclib with fulvestrant, Baroness Morgan added:

This provisional rejection also shows that there is still work to do to ensure the recent changes to the NICE process enable positive outcomes to be reached more quickly.

The move towards earlier discussions between a manufacturer and NICE on both clinical and cost issues has in this instance unfortunately failed to achieve faster progress. This example must now be considered as part of the upcoming NICE review of its methods and process.