NICE rejects Halaven for breast cancer
pharmafile | April 3, 2012 | News story | Sales and Marketing | Eisai, Halaven, NICE, breast cancer
NICE has rejected Eisai’s novel breast cancer drug Halaven, due to concerns over its safety and costs.
In its final 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’s 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 [chemotherapy agent] vinorelbine, [Roche’s Xeloda] capecitabine and, more rarely, [Lilly’s Gemzar] gemcitabine.”
Dillon added: “The experts also stressed that even if eribulin were approved by NICE, it would be unlikely to replace capecitabine and vinorelbine […] because of its related side effects.”
NICE did find that treatment with Halaven was found to potentially extend life by 2.7 months compared with standard chemotherapy treatment, but the watchdog still believes that its side effects made its overall benefit uncertain.
Since the last round of guidance, Eisai provided more information to NICE for a subgroup of people previously treated with Xeloda.
However, the watchdog said that the survival advantage in this subgroup was ‘not thought to be robust’.
Given this uncertainty, NICE concluded that no convincing cost effectiveness estimate had been presented for this subgroup.
Eisai has also 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.
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.
Although NICE has not recommended the drug for regular funding on the NHS, doctors and patients can still access Halaven through England’s Cancer Drugs Fund.
Eisai’s drug was accessed 143 times in the last nine months of 2011, making it one of the most commonly approved cancer drugs through the Fund.
Eisai reacts
Eisai appealed against NICE’s earlier decision not to recommend its drug, but the appeal was dismissed on all counts.
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.”
Ben Adams
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