The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending breast cancer drug abemaciclib with fulvestrant for use on the Cancer Drugs Fund. This will offer a new treatment option for patients with hormone receptor positive, HER2 negative locally-advanced or metastatic breast cancer after prior endocrine therapy.

Abemaciclib (Verzenios, Lilly UK) 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, 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 (MONARCH 2) has shown that giving abemaciclib in combination with fulvestrant extends the time before a patient’s condition progresses (progression free survival) by 7.1 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.

Abemaciclib plus fulvestrant is the first breast cancer treatment to be recommended for use on the new Cancer Drugs Fund (CDF). 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.

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

This is absolutely fantastic news and will now open the door for thousands of women who have received prior hormone therapy to benefit from innovative CDK 4/6 inhibitors, which until now had only been available to newly-diagnosed patients [with locally-advanced or metastatic breast cancer.

Abemaciclib is part of a new generation of medicines that can slow the spread of incurable breast cancer, and it’s really exciting that even more women will be now be able to benefit from it. 

This new combination can offer patients precious extra months before their disease progresses – time to live well that will be so important to them and their loved ones. Being progression-free for longer and able to continue with normal activities such as working is highly-valued by patients, and this combination could also help delay the need for chemotherapy and the difficult side effects that come with it. 

We are really encouraged that Lilly UK, NHS England and NICE have worked together to ensure patients can access this important new option whilst further data on its full benefits are collected. 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 results to understand whether this combination will also extend patients’ lives overall.

NICE’s draft guidance also noted that abemaciclib with fulvestrant has been recommended for patients where the most appropriate treatment alternative would be exemestane with everolimus.

On the NICE recommendation that this combination be used only if everolimus plus exemestane is the most appropriate alternative, Baroness Morgan added: 

As everolimus with exemestane is considered by NICE to be the most effective existing treatment following hormone therapy, it will already be one of the options considered and discussed with patients and this recommendation therefore should not act as a barrier to the use of abemaciclib with fulvestrant in this patient group, and we’ll be monitoring the use of this new option.

However, the fact that NICE has had to include this technicality in its recommendation to enable this new combination to be deemed cost-effective highlights a fundamental issue in its appraisal methodology that needs to be addressed. 

New drugs, and particularly combination therapies, can struggle to be considered cost-effective compared to generic drugs that are widely and cheaply available, and we must ensure the system is fit-for-purpose to appraise modern cancer drugs. It is now essential that the issue of combination therapies is considered by the upcoming review of the NICE appraisal methodology.