NICE, the UK healthcare guidance body, has issued new guidance not recommending eribulin (also known as Halaven and made by Eisai), 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.
Commenting on the final guidance NICE 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.”
The manufacturer 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 Committee concluded that no convincing cost effectiveness estimate had been presented for this subgroup.
The manufacturer has agreed a patient access scheme with the health department of the UK Government which makes eribulin available at a discounted price.
The size of the discount is currently confidential.
However, even with this discount, NICE’s independent Appraisal Committee decided that eribulin was not cost effective enough to justify diverting money from elsewhere in the NHS in order to fund its use.
The Institute received one appeal on its final draft guidance for this appraisal. The appeal was dismissed on all counts. However, the Appeal Panel did recommend that the sections describing adverse events experienced with the drug and its comparator are revisited; which has been done.
NICE always publishes the outcome of an appeal as soon as possible, regardless of the appeal panel’s decision. This means that publication doesn’t necessarily take place on the regular NICE publication day, which is the fourth Wednesday of the month.