12 February 2021

The National Institute for Health and Care Excellence (NICE) has today (Friday 12 February 2021) announced its decision to provisionally not recommend breast cancer treatment abemaciclib with fulvestrant for routine use on the NHS in England following its time on the Cancer Drugs Fund since April 2019, because it has not been found to be a cost-effective use of NHS resources.

Abemaciclib (Verzenios, Lilly UK) is one of a class of drugs known as CDK4/6 inhibitors (abemaciclib, ribociclib, palbociclib), which work by targeting two crucial cell division proteins (CDK4 and CDK6). Abemaciclib with fulvestrant is for treating patients with hormone receptor positive, HER2 negative secondary breast cancer after prior endocrine (hormone) therapy.

For patients who have received prior hormone therapy, a major trial (MONARCH 2) showed that giving abemaciclib in combination with fulvestrant extends the time before a patient’s condition progresses (progression free survival) by 7.6 months on average, compared to fulvestrant alone. Updated data also demonstrated that in the full trial population the treatment combination improved overall survival, providing an additional 9.4 months on average, compared with fulvestrant.

Today’s draft recommendation will be out for consultation until Friday 5 March 2021, when the NICE committee will meet again to consider the responses before making a final decision on the use of this treatment. Any patients already receiving abemaciclib with fulvestrant will continue to be able to receive the drug, and new patients will be able to start treatment up to the point of a final rejection being confirmed.

Ribociclib with fulvestrant has been through the NICE reappraisal process following its time on the Cancer Drugs Fund and we are awaiting the decision. Palbociclib with fulvestrant has not yet been through the process.

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

“Today’s news that NICE has been provisionally unable to approve abemaciclib with fulvestrant for routine use on the NHS following its time on the Cancer Drugs Fund is a devastating blow for thousands of women with incurable secondary breast cancer who could benefit from this innovative treatment in future.1

Crucially, the side effects of this combination treatment differ to those of other CDK 4/6 inhibitors, and may be more tolerable for some women, so it’s vital new patients have this treatment option available to them, to help improve their quality of life during the treasured extra months the treatment can give them. The treatment can also help delay patients needing chemotherapy and enduring its associated side effects such as hair loss and cognitive impairment.

“Abemaciclib with fulvestrant is an example of continued advances in treatment and care for secondary breast cancer and it’s deeply concerning that new patients could be denied the chance to benefit from this progress. Whilst treatment will continue for women currently receiving it, NICE, NHS England and Lilly UK must work swiftly together to explore all possible solutions to see this provisional decision reversed, including considering additional discounts. Unless this happens, patients in the future will pay the price of being denied the precious chance this treatment brings to live well for longer.

“Anyone affected by breast cancer can call our free Helpline on 0808 800 6000 for information and support.” 

ENDS

Notes to Editor

1 Abemaciclib with fulvestrant is for treating patients with hormone receptor positive, HER2 negative secondary breast cancer after prior endocrine (hormone) therapy and has been available on the Cancer Drugs Fund since 2019.

This recommendation will not affect treatment with abemaciclib with fulvestrant that was started in the Cancer Drugs Fund before the final guidance is published. For those people, abemaciclib with fulvestrant will be funded by the company. If this provisional decision is made final, the impact will be on future patients as this treatment will no longer be an option.

A provisional decision means this is not NICE’s final guidance on this technology and recommendations may change after consultation. The closing date for comments on the consultation is 5 March 2021.