IQWiG rejects Tecfidera

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said relapsing-remitting multiple sclerosis drug Tecfidera dimethyl fumarate from Biogen Idec Inc. (NASDAQ:BIIB) offers "no additional benefit" over Rebif interferon beta-1a from Merck KGaA (Xetra:MRK). The Phase III trials were designed before the German pricing process was implemented, Biogen told BioCentury, and thus IQWIG was unable to assess the benefit of Tecfidera over Rebif because there are no data available from a head-to-head study.

Comments are due Aug. 22, with a final assessment from Germany's Federal Joint Committee (G-BA) expected in October. Biogen Idec, which declined to disclose the current price of Tecfidera in Germany, said it expects to determine a final German price for the oral dimethyl fumarate that activates the NF-E2-related factor 2 (Nrf2) pathway by mid-2015. ...