A breast cancer cell.
The National Institute of Health and Care Excellence (NICE) has approved the use of a new drug combo for some adults with an advanced form of breast cancer that’s spread to other parts of the body.
The combination of abemaciclib (Verzenios) and fulvestrant (Faslodex) was originally made available through the Cancer Drugs Fund back in 2019, as further data was being collected on its effectiveness. The latest decision means the drugs will now be routinely available on the NHS.
Ben Chiu, policy manager at CRUK, said it is “brilliant news” that people affected by this type of breast cancer will continue to have this treatment available to them.
Cancer Research UK scientists laid the foundations for its development over 30 years ago.
How does it work?
Abemaciclib is type of drug called a cyclin-dependent kinase 4/6 inhibitor (CDK4/6). It works by blocking proteins in cancer cells which allow the cancer to divide and grow.
Human versions of cyclin-dependent kinases were discovered by Paul Nurse, a Cancer Research UK scientist at the London Research Institute (LRI). For this discovery, Nurse was jointly awarded the Nobel Prize in 2001, along with his colleague Tim Hunt and a US researcher called Leland Hartwell, who first identified cyclin dependent kinases in yeast.
A life extending alternative
According to Meindert Boysen, director of the Centre for Health and Technology evaluation at NICE, people with this form of advanced breast cancer would at this stage usually be treated with exemestane plus everolimus.
However, this combination has been found to be poorly tolerated by patients and was only used for a small number of patients because it had similar effects to chemotherapy on quality of life.
But following the NICE decision, patients will now be able to access abemaciclib as a treatment option. The drug will be available to patients whose advanced hormone-receptor positive, HER2-negative breast cancer has spread to other parts of the body after receiving endocrine therapy.
Clinical trials did not directly compare abemaciclib plus fulvestrant with exemestane plus everolimus. However, an indirect comparison suggests that people having abemaciclib plus fulvestrant have longer before their disease worsens and live longer than people taking exemestane plus everolimus.
During the consultation period, experts heard the value to patients of having this drug as a treatment option, as it is an alternative to other drugs and has different side effects.
Boysen 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.”
More clinical data needed
Draft guidance from NICE in February did not support routine use in England as it had not been deemed cost-effective. But on the basis of an improved patient access scheme and economic modelling data provided by the makers Eli Lilly, the NICE committee decided that abemaciclib could be recommended as a cost-effective use of NHS resources.
It will now progress from being temporarily available on the Cancer Drugs Fund to routine commissioning.
Chiu noted: “It shows how important the Cancer Drugs Fund is in providing cancer patients with new treatment options for their disease.”
Wales and Northern Ireland typically follow NICE recommendations, so the combination is likely to be available in these nations too. Scotland has its own regulatory approval process through the Scottish Medicines Consortium (SMC).