Three months ago, the National Institute of Health and Care Excellence (NICE) issued guidance rejecting the use of Kisqali (ribociclib) for advanced breast cancer.
At the time, the organisation said that it was rejecting the drug developed by Novartis because the final trial data had yet to be released and it was therefore “not known whether Kisqali increases the length of time people live”.
Pharma Times reported that the statement also said that, along with the clinical uncertainties, “the cost-effectiveness estimates are much higher than NICE normally considers to be an acceptable use of NHS resources”.
But now NICE has changed its guidance and is recommending the use of Kisqali in combination with fulvestrant.
This has come after a new clinical trial showed that using Kisqali with fulvestrant showed an average progress-free survival of 14.6 months, as opposed to the 9.1 months recorded in those taking a placebo along with fulvestrant.
As a result of the new decision, Kisqali plus fulvestrant will now be available to patients on the NHS in England and Wales. This will be facilitated through the Cancer Drugs Fund in England and the Welsh New Treatment Fund in Wales.
It will be used to treat people with hormone-receptor positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer who have previously had endocrine therapy.
Patients whose cancer has spread around the breast or elsewhere in the body may be eligible for this treatment.
Novartis still has to wait to receive the NICE technology appraisal guidance, which is the final step in the approval process with the regulator.
Director of the NICE Centre for Health Technology Evaluation Meindert Boysen said: “Treatments that postpone disease progression are important because they can reduce the number of people who are exposed to the often unpleasant side effects of chemotherapy, and delay the need for its use in others.”
Ribociclib is what’s called a cyclin-dependent kinase 4 and 6 inhibitor. This means it works by inhibiting proteins in cancer. The effect is that it stops the cancer cells from dividing and growing.
Mr Boysen added that the organisation is “pleased” that Novartis has “agreed a commercial arrangement that will allow it to be made available to people with this type of breast cancer”.
Rose Gray, policy manager at Cancer Research UK, welcomed the decision from NICE, noting that it’s positive to see another option being offered to people whose cancer is no longer responding to hormone therapy.
She added that having an alternative to the drug combination approved earlier this year under the Cancer Drug Fund is important because “the drugs can cause different side effects in some patients”.
Ms Gray also noted that it was positive to see Novartis working with NICE to get Kisqali with fulvestrant approved after the initial rejection.
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