Negative draft guidance from UK's NICE for Eisai's Halaven

In yet another negative opinion for breast cancer use on the UK’s National Health Service, UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) today issued draft guidance on Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) for public consultation, saying that it does not recommend NHS funding of eribulin, a treatment for locally advanced or metastatic breast cancer.

Eribulin is a novel treatment indicated for patients with locally advanced or metastatic breast cancer whose disease has progressed after at least two chemotherapeutic regimens for advanced and metastatic disease. It was launched in the UK in April 2011 and some patients have already started to benefit from treatment. Before the approval of eribulin in the European Union, no single treatment has demonstrated a statistically-significant prolongation of median overall survival as shown in the clinical trial, said Eisai.

“We are hugely disappointed with the draft guidance issued by NICE. It has not recommended an innovative treatment for a vulnerable group of women with heavily pre-treated locally advanced or metastatic breast cancer, with a proven overall survival benefit,” commented Nick Burgin, European director of market access, at Eisai. He adds; “Despite the UK price of eribulin currently being the lowest in the world, and a further patient access scheme agreement with the Department of Health which makes eribulin available at a discounted price, and unique real-world comparative data that has demonstrated overall survival, NICE’s unwillingness to approve this treatment is a real surprise.”