IQWIG confirms an additional benefit of Eisai's Halaven

Following a benefit:cost re-assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that an additional benefit exists of Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) versus certain comparator therapies as defined by the Federal Joint Committee (G-BA) for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease has been proven.

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. The IQWiG has limited this positive assessment to patients who can no longer be treated with taxanes or anthracyclines. In the report published by the IQWiG, the Institute subsequently defined sub-populations and assessed the extent and probability of an additional benefit. Eisai is critical of some aspects of this approach and will address them in its written statement to the GB-A.

The G-BA is expected to publish its final decision after due consideration of the IQWiG report, written statements and an oral hearing at the end of January 2015, according to Eisai.