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Germany’s G-BA backs Eisai's breast cancer drug Halaven

Endorsement from cost watchdog the Federal Joint Committee (G-BA) comes just weeks after the drug was rejected by the UK's NICE

Eisai cancer drug Halaven eribulin

Eisai is celebrating after hearing that its breast cancer drug Halaven has been endorsed by Germany's cost watchdog, the Federal Joint Committee (G-BA), just weeks after it was rejected by the UK's NICE.

The G-BA said the results of the recently-published EMBRACE study show that Halaven (eribulin mesylate) has additional benefits compared to comparative drugs in women who have already had extensive prior treatment of metastatic or locally-advanced breast cancer.

It also concluded that Halaven has an expected and manageable safety profile "which is in line with other single-agent chemotherapy treatments for advanced breast cancer in this setting", according to Eisai.

The UK's National Institute for Health and Clinical Excellence (NICE), perhaps Europe's highest profile health technology assessment body, took a different stance in its final review of the drug earlier this month.

NICE concluded that the side effect burden with Halaven was higher than with other treatments such as vinorelbine and capecitabine, and that the drug did not provide enough benefit to justify its high cost.

But the G-BA, in its April 19 decision document, said Halaven's increase in survival did justify the product's annual cost of around €44,000. The EMBRACE study found that Halaven extended survival by around 2.7 months compared with the oncologist's treatment of choice.

The marine-derived drug received European Commission approval in March 2011 for the treatment of locally advanced or metastatic breast cancer whose disease has progressed after at least two chemotherapeutic regimens for advanced disease, including anthracycline and taxane-based regimens.

Halaven is already available and reimbursed in a number of European countries, as well as in the US, Japan, and Singapore, and achieved 10.9bn yen ($134m) in sales in the nine-month period to December 31, 2011, mostly from the US market. Eisai has forged an alliance with Valeant Pharmaceuticals' PharmaSwiss unit to help drive sales growth in central and eastern Europe.

"Eisai recognises the decision of the G-BA which demonstrates support for innovative medicines in the area of oncology, where there are few treatment choices," commented Frank Zeymer, the company's oncology business unit director for the central region of Europe.

"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," he added.

23rd April 2012

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