Update (17/07/2019): the breast cancer treatment combo of ribociclib and fulvestrant has now been approved for NHS use in England thanks to price negotiations between the company and NHS England.
Patients in England living with a certain type of advanced breast cancer will not have access to a new combination treatment, after it was provisionally rejected on the NHS.
The National Institute for Health and Care Excellence (NICE) said people with breast cancer that is at an advanced stage or has spread around the breast or to other parts of the body, and is fuelled by the hormone oestrogen, will not be able to have the drugs ribociclib (Kisqali) and fulvestrant (Faslodex) in combination on the NHS.
The provisional decision applies to patients whose cancers also test negative for a molecule called HER2 (HER2 negative breast cancer). The treatment combo was being considered for patients who haven’t been treated or who have been treated with hormone therapy first.
The decision will be reviewed in May.
Cancer Research UK’s policy manager, Rose Gray, said: “This decision may be disappointing for people affected by this type of breast cancer.”
More time before disease gets worse
Ribociclib is a targeted cancer drug that interferes with mechanisms that helps cancer cells grow and divide. It’s been tested in combination with the hormone treatment fulvestrant.
“Clinical trial evidence suggests this treatment option could give patients more time before the disease gets worse,” said Gray, referring to a study including 726 patients who had gone through the menopause.
484 patients were treated with ribociclib and fulvestrant and the rest received fulvestrant and a dummy drug (placebo).
The cancer progressed sooner on average in those taking fulvestrant and the placebo compared to those who took ribociclib and fulvestrant.
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).
Weighing up options
Other targeted treatment options are already available for patients who have not received any previous treatment for HER2-negative disease where the cancer’s growth is being driven by oestrogen.
But Gray said the combo would have offered patients who have previously had hormone therapy an alternative to a different drug combination approved for the Cancer Drugs Fund last week. “This is important because the treatments can cause different side effects in some patients,” she added.
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.
Not cost effective
Because the trial did not directly compare ribociclib and fulvestrant against the treatment patients who had previously received hormone therapy would be offered on the NHS, NICE said it couldn’t be sure that the combination was cost effective, even if more data was collected on survival.
This is why the treatment wasn’t added to the Cancer Drugs Fund, which can pay for drugs offered on the NHS while more data is collected on their effectiveness.
“We urge NICE, NHS England and the drug’s manufacturer to work together before NICE reviews this decision next month and explore how this treatment can be made available to NHS patients,” said Gray.
NICE (2019) Ribociclib in combination with fulvestrant for treating advanced hormone-receptor positive, HER2-negative breast cancer [ID1318]