Germany's G-BA backs Eisai's Halaven; IQWiG finds some added benefit for Eliquis and rilpivirine

The German Federal Joint Committee (G-BA), the supreme decision-making body of the self-governing medical system in Germany, says that it considers the use of Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) to have additional benefit versus comparative treatments, defined by the G-BA for women who have already had extensive prior treatment of metastatic or locally advanced breast cancer. The decision comes despite a negative initial assessment by the G-BS’s advisory body, the IQWiG (The Pharma Letter February 17).

The G-BA’s assessment is based on the results of the EMBRACE study, previously published in The Lancet. This pivotal Phase III trial demonstrates that eribulin is the first, single-agent chemotherapy to show a statistically significant overall survival benefit in women with heavily pre-treated advanced breast cancer (compared to treatment of physician choice). Eribulin has an expected and manageable safety profile which is in line with other single-agent chemotherapy treatments for advanced breast cancer in this setting.[

"Eisai recognizes the decision of the G-BA which demonstrates support for innovative medicines in the area of oncology, where there are few treatment choices. The development of breakthrough chemotherapies such as Halaven is vital to prolong the time women with advanced breast cancer can spend with their loved ones," commented Frank Zeymer, Eisai's Oncology Business Unit director, Region Central, based in Germany.