eribulin (Halaven)

following a re-submission under the end of life and orphan equivalent process

eribulin (Halaven®) is accepted for restricted use within NHS Scotland.

Indication under review: for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.

SMC restriction: for use in patients with locally-advanced or metastatic breast cancer who have progressive disease after at least two prior chemotherapeutic regimens for advanced disease which includes capecitabine if indicated.

In a randomised, phase III, open-label study, median overall survival was extended by 2.5 months in patients treated with eribulin compared with the comparator, treatment of physician’s choice, which included a range of single agent chemotherapy treatments. In the subgroup of patients previously treated with capecitabine the extension to median overall survival was 2.9 months.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of eribulin. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

This supersedes previous advice for eribulin (SMC No. 726/11).