New draft guidance from NICE recommends twice-daily abemaciclib with fulvestrant for adults with hormone receptor-positive, HER2-negative breast cancer


Newly published draft guidance from NICE now recommends abemaciclib with fulvestrant as an option for adults with hormone receptor-positive, HER2-negative breast cancer after endocrine therapy.

In February, NICE provisionally rejected abemaciclib for routine use on the NHS because it was not considered a cost-effective use of the health system’s resources.

The new positive recommendation follows an improved patient access scheme from the manufacturer, Eli Lilly. This, taken together with further economic modelling data provided by the company, means that abemaciclib can now be recommended as a cost-effective use of NHS resources.

Abemaciclib for advanced breast cancer

Abemaciclib is a CDK4/6 inhibitor that blocks proteins in cancer cells that allow the cancer to divide and grow. It is given with the hormonal therapy drug fulvestrant in adults who have had hormonal therapy.

During consultation on the previous draft recommendations the committee heard further of the value to patients of having abemaciclib as a further treatment option. This is because it is an alternative CDK4/6 inhibitor to others currently available and has different side effects. Having this option is useful to help manage the side effects associated with these drugs.

NICE’s draft guidance means abemaciclib will now come out of the Cancer Drugs Fund and be made available routinely as an option where exemestane plus everolimus would be the most appropriate alternative treatment to a CDK 4/6 inhibitor. It is estimated that around 2500 people could be eligible for treatment with abemaciclib under this guidance.

‘Welcomed by patients’

Meindert Boysen, Director of the Centre for Health and Technology Evaluation at NICE, said: Advanced breast cancer is an incurable condition and the aim of treatment is to delay it getting worse and extend survival. The committee heard that CDK4/6 inhibitors like abemaciclib were welcomed by patients because they can delay the time before their cancer gets worse and so delay or avoid the need for chemotherapy.

‘The committee also heard from the patient experts that exemestane plus everolimus, the treatment that would normally be used at this stage, was poorly tolerated and used for only a small number of people because it has similar effects to chemotherapy on quality of life. We are therefore very pleased to be able to recommend that abemaciclib with fulvestrant can now be provided routinely as another option for people with advanced breast cancer who have already had endocrine therapy.’

Baroness Delyth Morgan, Chief Executive at UK breast cancer charity, Breast Cancer Now, commented that the approval of abemaciclib with fulvestrant for routine use on the NHS, following its time on the Cancer Drugs Fund, is ‘fantastic news for thousands of women with hormone receptor-positive, HER2 negative incurable secondary breast cancer.’

‘Following its worrying provisional rejection by NICE earlier this year, this decision now secures its future use on the NHS, bringing hope to eligible women who could see this combination treatment offer them precious extra months before their disease progresses and it could even help extend their lives,’ she said.

‘Furthermore, abemaciclib with fulvestrant could help women have the best quality of life possible in these extra months with side effects that may be more tolerable for some women than those of other CDK 4/6 inhibitors available on the NHS. This treatment can also delay the need to start chemotherapy and enduring its debilitating side effects’.

NICE expects to issue its final guidance on abemaciclib given with fulvestrant for hormone receptor-positive, HER2-negative metastatic breast cancer in September.