Having just launched Halaven in Japan, Eisai has been stunned by a rejection from the UK's cost watchdog for the advanced breast cancer drug.

The National Institute for Health and Clinical Excellence has issued draft guidance saying that it has not been able to recommend Halaven (eribulin) for the treatment of metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens. NICE chief executive Andrew Dillon said while studies indicated that eribulin could potentially help patients live for a little longer," it also caused more negative side effects than the other treatments and the effects on health-related quality of life had not been adequately assessed".

Discount proposed

NICE noted that Eisai has agreed a patient access scheme with the Department of Health which makes the drug available at a discounted price, though the size of the discount is currently confidential. The agency then went on to claim that the estimated cost per quality adjusted life year (QALY) gained of eribulin compared with 'treatment of physician's choice' is thought to be in excess of £68,600.

NICE added that it had heard from clinical experts that in current practice, palliative chemotherapy after anthracyclines and taxanes is usually sequential monotherapy with vinorelbine, capecitabine and, more rarely, gemcitabine. These experts claimed that if eribulin were approved by NICE, it would be unlikely to replace capecitabine and vinorelbine "in the established sequential pathway because of its toxicity profile and would only be offered as a third or fourth-line option".

The guidance is now up for public consultation and unsurprisingly Eisai does not agree with NICE's assessment. Nick Burgin, European director of market access for the Japan-based firm, said "we are hugely disappointed" that the agency 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".

Lowest price in the world in UK

He told PharmaTimes World News that the UK price for Halaven is currently "the lowest in the world by some distance" and that would be discounted again through the proposed deal with the DoH. Mr Burgin added that Eisai had also provided "unique real-world comparative data" from Europe and the USA that has demonstrated overall survival over three months, so "NICE’s unwillingness to approve this treatment is a real surprise".

He went on to state that NICE had "over-stressed the side effects" of taking Halaven, with alopecia being highlighted. Many would argue that hair loss may not be seen as a priority for patients with advanced breast cancer and Mr Burgin said the company will "challenge some assumptions" made in the draft guidance.

Halaven is currently marketed in a number of European countries ("it is going fantastically well in Germany," Mr Burgin noted) and the USA, where the response from clinicians has been extremely positive. Eisai has this week also launched the drug in Japan.