Today the National Institute for Health and Clinical Excellence (NICE) has announced that it will continue to not recommend Halaven® (eribulin) for the treatment of locally advanced or metastatic breast cancer in England and Wales, despite this novel and innovative therapy demonstrating proven benefits of improving overall survival rates,[1] with an expected and manageable safety profile. [2]

The news comes after an appeal against NICE’s earlier ruling in November last year, however NICE has observed that ‘the discussion and decision of the Appraisal Committee on toxicity were not reported appropriately in the Final Appraisal Document (FAD)’. The corresponding sections of the FAD are being re-drafted in light of the error. Despite the need for new treatment options, their overall recommendation denying eribulin use in England and Wales remains.

Eribulin is the first, single-agent chemotherapy to show a statistically significant overall survival benefit in patients with heavily pre-treated advanced breast cancer (compared to treatment of physician choice). 2 Importantly, eribulin has an expected and manageable safety profile which is in line with other single-agent drug treatments for advanced breast cancer in this setting2, a factor which was not recognised correctly by NICE.

Eribulin is already available and reimbursed in a number of countries throughout Europe and NICE’s refusal to recommend the treatment further demonstrates the inequality of access to cancer treatments for patients in the UK compared to other countries. NICE’s decision restricts NHS access to eribulin in England and Wales. Fortunately the new drug can be accessed in England through the Cancer Drugs Fund* where it has been approved in eight of the ten regions of the country.

The decision is viewed by Eisai as another example of NICE making decisions relating to new oncology treatments based on costs-savings rather than patients’ needs and they are urging NICE to reconsider, although the only challenge remaining is through the High Court. Regardless, it is disappointing news for women with advanced breast cancer.

Note: approved CDF regions are Yorkshire and the Humber, North West, North East, West Midlands, East Midlands, East of England, South East Coast and London