Added benefit of Eisai's Halaven not proven, says Germany's IQWiG

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the country’s Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Japanese drug major Eisai’s (TYO: 4523) breast cancer drug Halaven (eribulin) – which was approved by the European Commission last spring (The Pharma Letter March 25, 2011) - offers an added benefit compared with the present standard therapy, concluding that it does not.

According to the results of the assessment, the currently available evidence provides "hints” that eribulin may increase survival time in patients for whom taxanes or anthracyclines are no longer an option. However, says the IQWiG, it is unclear how many more weeks or months patients can survive. No survival advantage was shown in patients who can still be treated with taxanes or anthracyclines. At the same time, due to a lack of suitable data it cannot be excluded with sufficient certainty that eribulin causes greater harm in the form of side effects. Overall, IQWiG therefore concludes that an added benefit of eribulin is not proven.

As appropriate comparator therapies, the Federal Joint Committee (G-BA) has specified either monotherapy with capecitabine, 5-fluorouracil, or vinorelbine or renewed therapy with taxanes or anthracyclines, insofar as this is an option for patients. Eisai followed this specification of the appropriate comparator therapy. However, by the wording of the research question and the inclusion criteria of the dossier, the company also allowed other treatments as a comparator therapy for eribulin.