NICE will not back Eisai’s Halaven
pharmafile | November 17, 2011 | News story | Medical Communications, Sales and Marketing | Eisai, Halaven, NICE, breast cancer
NICE has not recommended Eisai’s novel breast cancer drug Halaven due to concerns over its safety and cost.
In draft guidance NICE said it could not recommend Halaven (eribulin) for the treatment of locally advanced or metastatic breast cancer in patients whose disease has progressed after at least two chemotherapeutic regimens.
NICE chief executive, Sir Andrew Dillon said: “Although the evidence presented to the independent advisory committee indicated that [Halaven] 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 had not been adequately assessed.”
Dillon said the advisory committee heard from clinical experts that in current practice patients at this stage usually receive treatment of several chemotherapy treatments, including vinorelbine, Roche’s Xeloda (capecitabine) and, more rarely, Lilly’s Gemzar (gemcitabine).
“The experts also stressed that even if [Halaven] were approved by NICE, it would be unlikely to replace [Xeloda] and vinorelbine … because of its related side effects,” said Dillon.
Eisai has offered the Department of Health a patient access scheme that would see the overall price reduced, but this was still not enough to sway the watchdog.
The cost of a vial of a 1.0 mg of eribulin mesylate (equivalent to 0.88 mg eribulin) is £313, but the PAS will make this cheaper – details of just how much cheaper have however been kept confidential.
In a statement NICE said that even with this discount, the 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”.
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 – over double what NICE would usually recommend.
The drug is an injectable non-taxane, microtubule dynamics inhibitor. It is also a halichondrin, a natural product isolated from the marine sponge Halichondria okadai, and is believed to work by inhibiting cancer cell growth.
Nick Burgin, European Director of Market Access, Eisai said the company was “dismayed” with this final NICE appraisal, as it denies women access to a treatment that is proven to prolong life.
“Eribulin is an innovative agent currently being offered to the NHS at the lowest price in the world. Eisai has tried to make eribulin affordable in England and Wales and has offered a discount on the price of the new drug. We feel that patients should not be unable to access a life-prolonging drug like eribulin on the basis of an arbitrary threshold of cost per quality adjusted life year (QALY) used by NICE and we plan to appeal this decision.”
Ben Adams
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