NICE says no to Eisai’s cancer drug Halaven

Eisai's breast cancer drug has failed to win the backing of the UK's National Institute for Health and Clinical Excellence (NICE), despite offering a patient access scheme that would have cut its price for the NHS in England and Wales.

The cost of the drug was a problem for NICE, but the Institute's final guidance took particular issue with the side effects associated with Halaven (eribulin), which include fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia.

Chief executive Sir Andrew Dillon said: “Although the evidence presented to the 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 committee felt that eribulin's effects on health-related quality of life had not been adequately assessed.

“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.”

NICE was assessing Halaven as a treatment for locally advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease.

In its final guidance NICE said Halaven potentially extended life by 2.7 months compared with 'treatment of physician's choice'. The Institute usually requires an additional three months of life to fulfill its end-of-life criteria, which might have gone some way to swaying its appraisal committee.

Halaven normally costs £313 per 1mg vial, but Eisai agreed a patient access scheme with the Department of Health to reduce this, although the size of the discount remains confidential.

But even with this reduced price NICE still estimated Halaven's most plausible cost per quality adjusted life year (QALY) would be more than £68,600, and concluded the drug does not provide enough benefit to patients to justify its high cost.

Following the guidance consultation period Eisai provided additional analyses on people previously treated with Roche's Xeloda (capecitabine), but NICE said the assessment of survival advantage in this subgroup “was not thought to be robust”.

In light of this NICE's Appraisal Committee concluded that no convincing cost effectiveness estimate had been presented for this subgroup.

Eisai said the drug had “an expected and manageable safety profile” and was the first, single-agent chemotherapy to show a statistically significant overall survival benefit in women with heavily pre-treated advanced breast cancer.

Nick Burgin, European director of market access at Eisai, said: "Eisai is dismayed that NICE has chosen not to rethink its denial of eribulin for women with locally advanced or metastatic breast cancer in England and Wales. At this point NICE is not giving enough support to women with advanced breast cancer and the physicians who want to treat them.

“We hope that NICE grant a rapid re-review as new data is constantly emerging that will help inform their decision."

The pharma company had appealed NICE's negative final draft guidance but the only concession it won was that NICE agreed to redraft sections in its Final Appraisal Document that related to Halaven's toxicity.

The company said Halaven would continue to be available to patients in England through the Cancer Drugs Fund, where it was one of the twelve most prescribed drugs to date.