In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) says it has not been able to recommend Eisai's Halaven (eribulin) for the treatment of locally-advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease.

Although the evidence presented to NICE's independent advisory committee indicated that eribulin may help some patients live for a little longer, it also caused more undesirable side effects than other treatments already available, and the effects on health-related quality of life have not been adequately assessed, said NICE's chief executive, Sir Andrew Dillon.

"The advisory committee heard from clinical experts that in current practice, patients at this 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," Sir Andrew added.

The most common adverse effects experienced with the drug are fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia, says NICE.

Also, Halaven did not fulfil all the end-of-life criteria, it adds. The appraisal committee said it had not seen sufficient evidence to indicate that the drug offers an extension to life of at least three months, being found to potentially extend life by 2.7 months compared with "treatment of physician's choice."

The Institute points out that the manufacturer had provided additional analyses following the consultation period for the subgroup of people previously treated with capecitabine. However, the assessment of survival advantage in this subgroup was not thought to be robust, and, given this uncertainty, the appraisal committee concluded that no convincing cost-effectiveness estimate had been presented for this subgroup.

The cost of a vial of 1.0mg of the product is £313, and the manufacturer has agreed a patient access scheme (PAS) with the Department of Health which makes Halaven available at a discounted price. The size of the discount is currently confidential but, even with this discount, NICE's appraisal committee decided that the drug was not cost-effective enough to justify diverting money from elsewhere in the NHS in order to fund its use, says NICE.

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

The final draft guidance is now with consultees, who have the opportunity to appeal against it, and Eisai has said it intends to assess the final appraisal determination to determine grounds for appeal and will do "all it can to ensure patient access to eribulin."

"We are dismayed with this final NICE appraisal as it denies women access to a treatment that is proven to prolong life and provides an opportunity for the NHS to improve cancer outcomes in metastatic breast cancer patients," said Nick Burgin, Eisai's European director of market access. "Eribulin is an innovative agent currently being offered to the NHS at the lowest price in the world," he said, adding: "we feel that patients should not be unable to access a life-prolonging drug like eribulin on the basis of arbitrary threshold of QALY used by NICE, and we plan to appeal this decision."