The National Institute for Health and Clinical Excellence released
draft guidance Wednesday, recommending against NHS reimbursement of
Eisai's Halaven (eribulin) as a treatment for advanced breast cancer.
The company said it was "hugely disappointed" with the decision, and
would work to overturn the recommendation.
Andrew Dillon, NICE's chief executive, noted that the main evidence
submitted by Eisai in support of the drug was based on single trial that
compared Halaven to doctor's choice of treatment. "Although the study
indicated that [Halaven] could potentially help patients live for a
little longer, it also caused more negative side effects than the other
treatments," Dillon remarked. The agency also indicated that if Eisai's
agent was backed by NICE, because of its toxicity profile it would
likely only be offered as a third- or fourth-line option after treatment
with vinorelbine and Roche's Xeloda (capecitabine).
Specifically, NICE recommended against use of Halaven as a treatment
for locally advanced or metastatic breast cancer in patients whose
disease has progressed after at least two regimens of chemotherapy for
advanced disease. The decision came despite Eisai offering to make the
agent available at a discounted price. According to the drugmaker, the
British price of the medicine was currently the lowest in the world.