Eisai's breast cancer drug approved by NICE in draft guidance

New evidence means that the medicines cost-effectiveness watchdog for England and Wales can now provisionally recommend breast cancer drug eribulin for some people with breast cancer.

In its draft updated guidance published today, the National Institute for Health and Care Excellence (NICE) has said Japanese pharma major Eisai’s (TYO: 4523) Halaven (eribulin) should be an option for people with locally-advanced or metastatic breast cancer that has spread after at least two chemotherapy regimens (which may include an anthracycline or a taxane, and capecitabine).

Eribulin is recommended only if the company provides the discount agreed in the patient access scheme. The drug has been available in the Cancer Drugs Fund and the NICE is now recommending it provisionally for routine use.

“When we first looked at eribulin in 2012 there wasn’t enough evidence of its clinical effectiveness compared with current standard treatments to be able to recommend it as a cost effective use of NHS resources,” said Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation.

She continued: “For this appraisal we’ve been able to consider updated results from the trial used in the original guidance that show women taking eribulin lived on average almost three months longer compared with women taking other treatments. We’ve also been able to take into account the results for health-related quality-of-life from another trial that compared eribulin with capecitabine. This new evidence, together with the discount available through the patient access scheme, enabled the appraisal committee to conclude that eribulin represents good value for money. The life expectancy of people for whom eribulin is licensed is short, and quality of life is very important. We are therefore pleased to be able to provisionally recommend eribulin as an additional option for people with advanced breast cancer.”

The NICE appraisal committee considered that, in light of the short life expectancy of people with this stage of breast cancer – typically less than two years – the overall survival benefit demonstrated in the EMBRACE trial of more than three months for eribulin compared to standard treatment was substantial. The committee therefore concluded that eribulin met the NICE’s criteria for drugs that prolong life at the end of life, allowing greater weight to be applied to its QALY (quality-adjusted life-year) benefits.

Simple price discount agreed

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of eribulin, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.