NICE Recommends Abemaciclib for HR+/HER2– Advanced Breast Cancer

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued draft guidance supporting the use of abemaciclib (Verzenio) in the treatment of adult patients with metastatic hormone receptor (HR)–positive/HER2-negative breast cancer.¹

The announcement reverses a February decision denying approval for routine use of the agent because the CDK4/6 inhibitor had not been found to be a cost-effective option. The Guardian reported that drug maker Eli Lilly gave a discount for the twice-daily tablet and improved plans for patient access. The drug normally costs £2,950 ($4,072.11) for a packet of 56 tablets. The amount of the discount has not been released.

The draft guidance means abemaciclib will now come off the Cancer Drugs Fund, which covers costs for agents that are either not yet approved by NICE or that have been rejected for not being cost effective. Abemaciclib will now be routinely available as an option where exemestane plus everolimus (Afinitor) would be the most appropriate treatment alternative to a CDK4/6 inhibitor. An estimated 2500 patients could be eligible for treatment with abemaciclib under this guidance.

Patient experts have expressed that standard-of-care exemestane plus everolimus was poorly tolerated, according to Meindert Boysen, director of the Centre for Health and Technology Evaluation at NICE. Moreover, the combination was appropriate for only a small number of patients because it produces quality-of-life effects that are similar to that of chemotherapy.

“The committee heard that CDK4/6 inhibitors like abemaciclib were welcomed by patients because they can delay the time before their cancer gets worse and so delay or avoid the need for chemotherapy,” Boysen said. “We are, therefore, very pleased to be able to recommend that abemaciclib with fulvestrant [Faslodex] can now be provided routinely as another option for patients with advanced breast cancer who have already had endocrine therapy.”

This guidance is provisional. NICE expects to issue final guidance on abemaciclib/fulvestrant for HR-positive, HER2-negative metastatic breast cancer in September 2021.

Previously, in 2018, the FDA approved abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer based on data from the phase 3 MONARCH 3 trial.

References

1. NICE draft guidance recommends abemaciclib for advanced breast cancer. News release. National Institute for Health and Care Excellence. August 12, 2021. Accessed August 12, 2021. https://bit.ly/3s996NG