NICE Draft Guidance Recommends Abemaciclib as an Option for Advanced Breast Cancer

Priscilla Lynch 

August 16, 2021

The National Institute for Health and Care Excellence (NICE) has published new draft guidance which recommends the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenios, Eli Lilly) as an option for adults with advanced breast cancer.

Previous draft guidance had rejected the treatment. One cancer charity called the change of heart "fantastic news".

Abemaciclib plus fulvestrant is now recommended as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have had endocrine therapy only if:

  • Exemestane plus everolimus is the most appropriate alternative to a CDK4/6 inhibitor.

  • The company provides abemaciclib according to the commercial arrangement.

The positive recommendation follows an improved patient access scheme from the company, said NICE. 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.

NICE’s draft guidance means abemaciclib will now come out of the Cancer Drugs Fund and be made available routinely as an option where exemestane plus everolimus would be the most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 CDK4/6 inhibitor.

It is estimated that around 2500 people could be eligible for treatment with abemaciclib under this guidance.

 'Fantastic News'

Meindert Boysen, director of the Centre for Health and Technology Evaluation at NICE, said: “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.”

Baroness Delyth Morgan, chief executive, Breast Cancer Now, said the decision was "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."

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

This article was adapted from Univadis, part of the Medscape Professional Network.

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