Chemotherapy can cause some of the healthy cells surrounding a tumour to make proteins that encourage hardy tumour cells to start growing again more aggressively after treatment. Credit: Jason Carroll at the CRI
Some patients with advanced breast cancer will now have access to a new treatment combination on the NHS in England, following the reversal of a previous decision by the National Institute for Health and Care Excellence (NICE).
The treatment combo of ribociclib (Kisqali) and fulvestrant (Faslodex), which was shown to slow disease progression in a clinical trial, was initially rejected for use by NICE in April 2019 over concerns the drugs didn’t provide value for money.
But price negations have enabled NICE to recommend NHS patients in England should have access to the drug. It joins a similar treatment combo on the Cancer Drugs Fund, which pays for early access to innovative treatments while more evidence is gathered on their effectiveness.
In this case, NICE will review whether the combination should be routinely made available to new patients once the clinical trial is completed at the end of 2020.
Rose Gray, Cancer Research UK’s policy manager has welcomed the “good news.” She said it was great to see NICE, NHS England and ribociclib’s manufacturer work together to ensure the treatment could be recommended following the initial rejection.
Drugs recommended for the Cancer Drugs Fund in England are also usually funded by the NHS in Wales and Northern Ireland too, so the treatment should be available to patients there as well. Decisions about what drugs the NHS should fund in Scotland are made separately by the Scottish Medicines Consortium.
The approved treatment combines ribociclib, a targeted cancer drug, with fulvestrant, which is an injectable hormone therapy.
The combination will be available for patients with advanced breast cancer that’s spread around the breast or to other parts of the body. But only for those whose cancer is fuelled by the hormone oestrogen and test negative for a molecule called HER2, and who have been treated with hormone therapy before.
NICE concluded that the combination treatment could delay the need for chemotherapy in those patients with aggressive disease.
“Clinical trial evidence suggests this treatment option could give patients more time before the disease gets worse,” said Gray, referring to a study comparing the combination to a dummy drug (placebo) in 726 women who had gone through the menopause.
Patients taking the combination treatment lived for 20.5 months on average without their cancer getting worse, compared with 12.8 months on average in those taking fulvestrant and a placebo.
But more than half of those taking ribociclib experienced a severe or life-threatening reduced number of white blood cells in their blood (neutropenia).
More options for patients
The combination of ribociclib and fulvestrant joins a growing list of treatments approved for people with this type of breast cancer. It will provide an additional option for patients whose cancer has stopped responding to hormone therapy.
NICE said the combo should only be used in cases where the only other option is a combination of two different drugs, a hormone therapy called exemestane (Aromasin) and the targeted drug everolimus (Afinitor).
“The treatment offers an alternative to a different drug combination approved for the Cancer Drugs Fund earlier this year – which is important because the drugs can cause different side effects in some patients,” said Gray. “And because it’s been recommended for the Cancer Drugs Fund, patients will be able to access the drug while more evidence is gathered about its longer-term benefits.”
Patients taking ribociclib and fulvestrant need regular heart check-ups and tests to make sure their liver is working properly. Whereas diarrhoea is more common in the recently approved combination of abemaciclib (Verzenio) and fulvestrant.
NICE (2019) Ribociclib in combination with fulvestrant for treating advanced hormone-receptor positive, HER2-negative breast cancer [ID1318]. Final Appraisal Document.