The National Institute of Health and Care Excellence (NICE) has issued a draft guidance which does not recommend Novartis’ Kisqali (ribociclib), which is typically used with fulvestrant to treat people with advanced breast cancer.
The draft guidance, which is now the subject of public consultation until May 9, 2019, does not recommend the drug combination for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine therapy.
The statement issued detailed that the decision was made because “it is not known whether Kisqali increases the length of time people live, because the final trial results are not available yet. Because of the uncertainties in the clinical evidence, and cost-effectiveness estimates that are much higher than NICE normally considers to be an acceptable use of NHS resources, Kisqali with fulvestrant cannot be recommended for routine use in the NHS.”
The decision was made despite the clinical trial evidence suggesting that compared with fulvestrant alone, Kisqali with fulvestrant increases the length of time before the disease progresses in people with previously untreated advanced disease and in people after a prior endocrine treatment.
The committee also heard from the patient expert that patients value improvements in progression-free survival and want to delay chemotherapy for as long as possible.
In the future, more data may address the uncertainties in the clinical trial evidence, but because the drug with fulvestrant does not have plausible potential to be cost effective at the offered price, it cannot be recommended for use.