In final guidance issued today, the National Institute for Health and Clinical Excellence (NICE) has rejected the use of Eisai's Halaven (eribulin) in locally-advanced or metatastic breast cancer which has progressed after at least two chemotherapeutic regimens for advanced disease.

Evidence presented to NICE's independent advisory committee indicated that the drug may help some patients live for a little longer, but it also caused more undesirable side effects than other, already-available treatments, and the panel also felt that its effects on health-related quality of life had not been adequately assessed, said NICE's executive director, Sir Andrew Dillon.

"The advisory committee heard from clinical experts that, in current practice, patients at the stage usually receive sequential treatment of vinorelbine, capecitabine and, more rarely, gemcitabine. The experts also stressed that, even if eribulin were approved by NICE, it would be unlikely to replace capecitabine and vinorelbine in the established sequential pathway because of its related side effects," he added.

Halaven was found to potentially extend life by 2.7 months compared with "treatment of physician's choice." The drug did not fulfil all the end-of-life criteria, and the most common adverse effects of the treatment are reported to be fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia.

Eisai had provided additional analyses for the drug, following a consultation period for the subgroup of people previously treated with capecitabine, but the assessment of survival advance in this subgroup was not thought to be robust. Given this uncertainty, the committee concluded that no convincing estimate of cost-effectiveness had been presented for this subgroup.

The cost of a 1.0mg vial of eribulin mesylate, equivalent to 0.88mg eribulin, is £313. Eisai has agreed a patient access scheme (PAS) with the Department of Health, making the drug available at a discounted price which is currently confidential. However, the committee concluded that, even with this discount, the drug is not sufficiently cost-effective to justify diverting money from elsewhere in the NHS in order to fund its use, the Institute reports.

The most plausible cost per quality-adjusted life year (QALY) gained by using Halaven compared with "treatment of physician's choice" was estimated to be in excess of £68,600, it adds.

Following the final draft guidance which it issued for this appraisal, NICE received one appeal, but this was dismissed on all counts. However, the Appeal Panel did recommend that the sections describing adverse events experienced with the drug and its comparator should be revisited, and this has been done, says the Institute.

- NICE also notes that it always publishes the outcome of an appeal as soon as possible, regardless of the Appeal Panel's decision, which means that publication does not necessarily take place on the fourth Wednesday of the month - NICE's regular publication day.