NICE refuses Eisai’s breast cancer drug in new indication

pharmafile | November 28, 2017 | News story | Manufacturing and Production, Sales and Marketing Cancer, Eisai, Halaven, NICE, breast cancer, pharma 

NICE has announced that it has rejected Eisai’s Halaven (eribulin) through draft guidance advising not to use the drug in locally advanced or secondary breast cancer in patients who have previously undergone only one chemotherapy regimen.

This new decision was made due to a lack of compelling clinical evidence demonstrating Halaven’s efficacy, and therefore it could not deem the drug cost-effective for use on the NHS in England and Wales. Instead, patients are generally offered an anthracycline, taxane or capecitabine.

The evidence provided showed that the drug improved overall survival by 4.6 months on average compared to capecitabine, but failed to provide any progression-free survival time during which the tumour does not grow. Therefore, NICE asserts that it cannot determine whether this benefit is attributable to Halaven, or effective treatments administered afterwards.

“Because of the uncertainty in the clinical evidence, the most plausible cost-effectiveness estimates are likely to be at the top of this range, which is above what NICE normally considers to be acceptable for end-of-life treatments,” a statement from the organisation read.

However, this is only the latest decision the UK watchdog has made on Halaven – it is already recommended for patients with locally advanced or secondary breast cancer who have already undergone two chemotherapy regimens.

NICE now awaits additional evidence before making its final appraisal determination.

Matt Fellows

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