Eisai disappointed after NICE rejects earlier use for breast cancer drug

Eisai has been dealt another disappointment from NICE, which says its breast cancer drug Halaven should not be regularly used on the NHS.

The company noted that the Halaven (eribulin) continues to be available for patients in third line – but more recently NICE had been assessing the drug after one chemotherapy regimen.

In the final guidance NICE said it was unclear whether a 4.6 month overall survival increase compared with capecitabine chemotherapy was down to treatments given after Halaven.

NICE noted that the drug did not increase progression free survival compared with chemotherapy, and that Halaven therapy is usually stopped once the disease progresses.

The uncertainty caused means that the cost per Quality Adjusted Life Year for Halaven in this use is around £69,800, according to NICE’s calculations.

This is too expensive for the NHS, even though NICE has extra leeway above its usual £30,000 threshold.

But Gary Hendler, Chief Commercial Officer Eisai Oncology Business Group, and chairman and CEO Eisai EMEA said he was “disappointed” after another knock-back from NICE.

Although NICE recommended funding for Eisai’s Lenvima (lenvatinib) in thyroid cancer last month, this was after a wait of more than two years primarily because of a change to the way NICE and the Cancer Drugs Fund are organised.

Halaven was also removed from the Cancer Drugs Fund under previous arrangements in 2015 because it was overspent. However this decision was eventually reversed and the drug was eventually rubber-stamped for regular NHS funding in late 2016.

[caption id="attachment_16760" align="alignnone" width="135"] Eisai's Gary Hendler[/caption]

Hendler said in a statement: "Eisai is yet again extremely disappointed with a decision from NICE. Metastatic breast cancer patients can only currently access a limited number of new treatments in England, and as eribulin has been shown to significantly improve overall survival in women with this disease it is an important option that they should have access to as early as possible.”

"Denying earlier access to it for these patients will affect their outcomes and as a company focused on making a positive difference to the lives of patients and their families, NICE's decision concerns us greatly. Thankfully patients can still access eribulin in the third line.”

Eisai, which has built a multi-million pound manufacturing base in Hertfordshire, has threatened to stop investing in the UK because of difficulties getting drugs reimbursed.

This is despite pharma-friendly initiatives such as tax breaks on drugs that are developed and manufactured in the UK.