NICE recommends interim funding for Lilly's breast cancer drug

Final draft guidance from NICE has recommended interim NHS funding for Eli Lilly’s Verzenios (abemaciclib) with fulvestrant, giving certain breast cancer patients an option that can delay chemotherapy after failure of endocrine treatment.

Around 4,800 women who could be eligible for the therapy already had endocrine treatment for hormone receptor-positive, HER2-negative breast cancer which has spread to other parts of the body. It will be an option where exemestane plus everolimus would be the most appropriate alternative treatment.

The body said Verzenios will be available immediately now that the final draft guidance has been published, and can be reimbursed by the Cancer Drugs Fund until confirmatory cost-effectiveness data is available.

Verzenios is the first CDK4/6 inhibitor to be made available in combination with fulvestrant as a second line treatment option for women whose disease has progressed while taking an aromatase inhibitor.

Rival CDK4/6 inhibitors Ibrance and Kisqali from Pfizer and Novartis respectively have only been available in combination with aromatase inhibitors.

Clinical trial evidence suggests that compared with fulvestrant alone, Verzenios with fulvestrant increases the length of time before the disease progresses.

NICE said 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.

This guidance will be reviewed when the final analysis of the phase 3 MONARCH 2 study is available, which is expected to be February 2020.

A managed access agreement between Eli Lilly, NICE and NHS England provides for a data collection period lasting until December 2021.

Verzenios is taken as a twice-daily pill and works by inhibiting proteins within cancer cells that allow it to divide and grow.

It normally costs £2,950 for a packet of 56 150 mg tablets, but Lilly has provided a confidential discount under the managed access agreement.

Meindert Boysen, director of the Centre for Health Technology Evaluation 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.

“Today’s recommendation is another example of NICE and NHS England collaborating effectively to give people faster access to promising cancer treatments through the Cancer Drugs Fund.”