NICE has recommended that abemaciclib with fulvestrant should be available for NHS use within the Cancer Drugs Fund (CDF) for hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, for patients who have had endocrine therapy and for whom exemestane plus everolimus would be the most appropriate alternative.
The decision is based on the data from the MONARCH 2 trial, which showed increased progression-free survival with abemaciclib plus fulvestrant compared with fulvestrant alone from 9.3 months to 16.4 months (HR 0.553; 95% CI 0.449-0.681, P
The uncertainty around the clinical benefit created uncertainty about the cost-effectiveness estimates. NICE said the most plausible estimates predict the cost of treatment would be higher than the threshold used to determine an acceptable use of NHS resources. The treatment has not been approved for routine use but has been approved for use under the CDF.
The guidance will be reviewed when the final analysis of the MONARCH 2 study is available, which is expected to be in February 2020.