NICE rejects Eisai's Halaven in new breast cancer use

NICE has said Eisai’s breast cancer drug Halaven should not be funded by the NHS in a new use, its first draft guidance citing uncertainty in the clinical evidence submitted.

Eisai already has a somewhat strained relationship with NICE, which took two years to review thyroid cancer drug Lenvima because of changes to its procedures, before rejecting it last month.

In this case NICE reviewed Halaven (eribulin) for advanced or secondary breast cancer in adults who have had only one chemotherapy regimen.

People with advanced breast cancer are usually offered anthracycline, taxane, or capecitabine after their first round of chemotherapy, depending on what they have already been treated with.

NICE noted that clinical evidence shows Halaven increases overall survival by an average of 4.6 months compared with capecitabine, but does not seem to slow the growth of the tumour as measured by progression-free survival.

In the guidance NICE said it is unclear whether the overall survival benefit is because of Halaven or because of treatments taken afterwards.

There are no clinical trials assessing different treatment sequences, NICE noted.

Halaven meets NICE’s criteria for a life-extending treatment at the end of life, which allows it greater leeway in its cost-effectiveness criteria.

NICE usually rejects drugs when their cost-effectiveness exceeds £30,000 per quality-adjusted life year (QALY), but end-of-life treatments can be funded with considerably higher costs.

But according to NICE’s calculations the cost of Halaven ranges from £36,422 to £82,743 per QALY, and because of the uncertainty in the evidence, the drug’s costs are likely to be at the top of this range, according to the guidance.

NICE already recommends Halaven as an option for adults with this type of cancer who have already had 2 chemotherapy regimens.

In response to the decision, Samantha Nicklin, assistant director of policy and campaigns at Breast Cancer Now, said: “That eribulin cannot offer women with metastatic breast cancer a new second-line therapy option is very disappointing news, particularly for patients with ‘triple negative’ breast cancer, who – despite recent advances for other subtypes of the disease – still have very few treatment options."

“Around 15% of all breast cancers are ‘triple negative’, which tend to be more aggressive, and studies have shown eribulin to have particularly important benefits for this patient group. With still no targeted treatments being available for this type of breast cancer these women remain in desperate need of more effective and more bearable alternatives to standard chemotherapy."

“Eribulin currently offers a vital third-line option for patients and is highly valued by clinicians, giving women with incurable breast cancer precious extra time with their loved ones, as well as a better quality of life than existing options.”