NICE has published draft guidance recommending third CDK4/6 inhibitor (abemaciclib) for routine NHS use.

Thursday 17 January 2019      Health information
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The National Institute for Health and Care Excellence (NICE) has published new draft guidance recommending breast cancer drug abemaciclib with an aromatase inhibitor as a new first-line treatment for patients with hormone-positive, HER2-negative locally-advanced or metastatic breast cancer.

Abemaciclib (Verzenios, Eli Lilly) is one of a class of drugs known as CDK4/6 inhibitors, which work by targeting two crucial cell division proteins (CDK4 and CDK 6). Other similar drugs called palbociclib and ribociclib were approved by NICE in November 2017 for use in treating this patient group, and today’s decision will now see a third option made available to patients and their doctors.

Clinical trials have shown abemaciclib to be as effective as palbociclib and ribociclib – offering patients significant extra time before their disease progresses, compared to an aromatase inhibitor alone. The opportunity for a greater quality of life for longer is known to be highly valued by patients. 

While the NICE Committee has reviewed the data on abemaciclib’s median progression-free extension, this data remains confidential until the trial’s publication. Trials are also set to establish whether abemaciclib (or palbociclib or ribociclib) can extend patients’ lives overall.

Abemaciclib is also currently being appraised by NICE in combination with fulvestrant, for another group of patients who have previously received hormone therapy – with a decision expected in early 2019.

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

It is fantastic that abemaciclib will now offer an alternative treatment option for thousands of NHS patients and their doctors. Abemaciclib is the third in an exciting new generation of medicines [called CDK4/6 inhibitors] capable of slowing the spread of the most common type of locally-advanced or incurable breast cancer.

Compared to hormone therapy alone, this new option can offer patients significant extra time before their disease progresses – time to live well that will be absolutely invaluable.

Crucially, this drug’s availability will now help improve patient choice, giving women even greater control over their quality of life. Abemaciclib has been shown to be just as effective as palbociclib and ribociclib, but can come with slightly different side effects. It’s now essential that all patients are fully informed of the benefits and risks of these different treatments and are supported to make the decision that’s right for them.

We also now look forward to the upcoming decision about a further use for this drug on the NHS. Research has shown that giving abemaciclib in combination with fulvestrant could offer a significant group of patients who have received prior hormone therapy an important new option, and we hope it can soon be made available at a price the NHS can afford.