Germany’s health technology assessment body the Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that Eisai’s breast cancer drug Halaven (erbulin) does indeed offer a benefit over other comparators on the market, but only in a restricted group of patients with the disease.

After a second review of available data the Institute said the drug’s survival benefit outweighed its side effects in patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen. But only in those who can no longer be treated with taxanes or anthracyclines, potentially squeezing its target population.

The reassessment is based on clinical data from two global Phase III trials; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus E7389) and Study 301, involving more than 1,800 women. EMBRACE showed that Halaven prolonged median overall survival in heavily pre-treated women with metastatic breast cancer by 2.7 months versus those receiving a ‘Treatment of Physician's Choice’. 

In line with the G-BA requirements, additional pooled analyses of data were specifically performed for the benefit assessment procedure in Germany and reviewed by the Institute, Eisai said, noting that it is “pleased that IQWiG has at least in part, and for the majority of patients acknowledged the additional benefit that Halaven may offer to women with metastatic breast cancer”.

Boosting confidence

“We estimate more than 11,000 women in Germany have had the chance to benefit from treatment with Halaven over the past three years and it is good news that the statistically significant and clinically relevant overall survival benefit has been confirmed again to further increase confidence in this innovative treatment option,” said Gary Hendler, Eisai’s European chief.

Eisai did say it has some criticisms of the assessment, which it will be passing on to the Federal Joint Committee (G-BA), which is expected to publish its final decision after taking IQWiG’s report, written statements and an oral hearing into account by the end of January 2015. 

Across the channel, the National Institute for Health and Care Excellence (NICE) turned down Halaven’s use on the National Health Service back in 2012, arguing at the time that even with its seal of approval the doctors would not replace standard treatments because of the side effects, and calculating the drug’s incremental cost to be more than £68,600 per QALY gained.