The National Institute for Health and Care Excellence (NICE) has today announced its decision to approve abemaciclib with fulvestrant for routine use on the NHS, following its time on the Cancer Drugs Fund since April 2019.
Abemaciclib (Verzenios) is one of a class of drugs known as CDK4/6 inhibitors - abemaciclib, ribociclib, palbociclib. These work by targeting two crucial cell division proteins: CDK4 and CDK6.
Abemaciclib with fulvestrant is for patients with hormone receptor positive, HER2 negative secondary breast cancer after prior endocrine - hormone -therapy.
A major trial called 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 improved overall survival, providing an additional 9.4 months on average, compared with fulvestrant.
In February 2021, the National Institute for Health and Care Excellence (NICE) provisionally rejected this treatment for routine use on the NHS, because it was not considered a cost-effective use of NHS resources.
Unless this decision was reversed, it would have meant new patients could not access this treatment in the future.
We responded to the consultation on the draft guidance and attended the second committee meeting.
More than 60 women shared their experience of the treatment with us, which helped make a powerful case as to why it's important women in future can access this treatment.
We also urged NICE, NHS England and pharmaceutical company Lilly UK to work together and explore every possible solution, to ensure this treatment remained an option for new patients on the NHS – including Lilly UK considering further discounts.
Although the Committee still state that the cost-effectiveness estimates vary, following an improved patient access scheme from the company, abemaciclib plus fulvestrant is now considered a cost-effective use of resources.
It will therefore be recommended for routine use on the NHS.
Ribociclib with fulvestrant has also been made routinely available on the NHS. Palbociclib with fulvestrant has not yet been through the reappraisal process.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
"Today's 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.
"This brings 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.
"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 endure its debilitating side effects.
"That NICE concluded it met a need for an alternative CDK 4/6 inhibitor, is testament to the many women who shared their experiences of the treatment with Breast Cancer Now.
"They supported our work to overturn the initial provisional rejection, ensuring it remained an option for women in the future.
"Together, we are turning the tide on breast cancer.
"We encourage women to discuss their breast cancer treatment options with their healthcare team. They can also speak to our expert nurses by calling our free Helpline on 0808 800 6000."
ENDS
Notes to Editor
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.