The National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s Verzenio (abemaciclib) when given with Faslodex (fulvestrant), to be available for NHS use within the Cancer Drugs Fund (CDF).
The decision is based on clinical trial evidence suggesting that compared with Faslodex alone, Verzenio with Faslodex increases the length of time before the disease progresses.
However, there is a lack of evidence around the overall survival benefit and around its cost-effectiveness, meaning it has been recommended for use within the CDF while more data is collected.
Meindert Boysen, director of the Centre for Health Technology Assessment at NICE, said: “The committee heard from patients that a treatment which could postpone or avoid the need for chemotherapy is important because chemotherapy has the potential to substantially reduce quality of life. They also highlighted the importance of people remaining in better health longer, without the disease progressing.
Thousands of women with advanced breast cancer may now be eligible for the new combination treatment, and the guidance will be reviewed when the final analysis of the MONARCH 2 study is available, which is expected to be February 2020.
NICE has already the drug in combination with an aromatase inhibitor as treatment option for locally advanced or metastatic breast cancer.
Verzenio was approved in Europe for the treatment of certain metastatic breast cancers in 2018, based on data from the Phase III MONARCH 2 and 3 trials, which found that combining the drug with an AI demonstrated a greater than 28-month median progression-free survival rate in patients who received initial endocrine-based therapy for metastatic disease.
Around 46,000 women are diagnosed with breast cancer each year in England and Wales, of whom the company estimates as many as 8000 would be eligible for treatment with Verzenio.