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Eisai fails to win NICE backing for breast cancer drug Halaven

UK cost effectiveness body says drug has unacceptable level of side-effects

The National Institute for Health and Clinical Excellence (NICE) has recommended against the use of Eisai's breast cancer drug Halaven (eribulin) on the NHS.

Halaven is being assessed 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In final draft guidance the Institute said that although study results suggested Halaven could help patients live longer, it caused more undesirable side-effects than already recommended treatments.

The drug's most most common adverse effects are fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia

NICE also said that Eisai had failed to adequately assess Halaven's effects on an individual's quality of life.

NICE's chief executive Sir Andrew Dillon said: “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.”

Eisai has agreed a patient access scheme with the Department of Health to make Halaven available at a discounted price, the details of which are confidential, but NICE said the drug was still not cost-effective enough even at this lower price.

The most plausible cost per quality adjusted life year (QALY) gained of Halaven compared with 'treatment of physician's choice' was estimated by NICE to be over £68,600.

NICE's draft guidance is now open to appeal, with final guidance due to be issued in December. Until then, NHS bodies can make decisions locally on funding the drug.

17th November 2011

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