Eisai’s Halaven Receives Final Draft “No” From NICE

In final draft guidance given yesterday, the National Institute for Health and Clinical Excellence (NICE) announced that they are not recommending Eisai’s Halaven (eribulin) for the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.

Although the evidence shown to NICE’s independent advisory committee indicated that eribulin might help certain patients live for a little longer, it also triggered more undesirable side effects than other treatments currently available, and the effects on health-related quality of life have not been sufficiently assessed, summarised Sir Andrew Dillon, NICE’s chief executive.

“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,” Sir Andrew added.

The most common adverse effects experienced with the drug are fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia, observed NICE.

In addition, Halaven did not fulfil all the end-of-life criteria.  The appraisal committee commented that it had not seen adequate evidence to indicate that the drug offers an extension to life of at least three months, being found to potentially extend life by 2.7 months compared with the “treatment of physician’s choice.”

The Institute notes that the manufacturer had provided further analysis 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 appraisal committee decided that no convincing cost-effectiveness estimate had been presented for this subgroup.

The recommended dose of eribulin, as the ready to use solution, is 1.23 mg/m2 (equivalent to 1.4 mg/m2 eribulin mesylate), which is administered intravenously over 2-5 minutes on days 1 and 8 of every 21-day cycle.

The cost of a vial of 1.0mg of the product is £313, and the manufacturer has agreed a patient access scheme (PAS) with the Department of Health which makes Halaven available at a reduced price.  The size of the discount is currently confidential but, even with the discount, NICE’s appraisal committee decided that the drug was not cost-effective enough to justify diverting money from elsewhere 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, says NICE.

The final draft guidance is now with consultees, who have the chance to appeal against it, and Eisai has said it intends to evaluate the final appraisal determination to determine grounds for appeal and will do “all it can to ensure patient access to eribulin.”

Nick Burgin, Eisai’s European director of market access, commented that Eisai “are dismayed with this final NICE appraisal as it denies women access to a treatment that is proven to prolong life and provides an opportunity for the NHS to improve cancer outcomes in metastatic breast cancer patients.”  “Eribulin is an innovative agent currently being offered to the NHS at the lowest price in the world,” he said, adding: “we feel that patients should not be unable to access a life-prolonging drug like eribulin on the basis of arbitrary threshold of QALY used by NICE, and we plan to appeal this decision.”



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