IQWiG rebuffs Roche's Erivedge

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that Erivedge vismodegib from Roche (SIX:ROG; OTCQX:RHHBY) has "no additional benefit" to treat symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC in patients for whom surgery or radiotherapy are considered inappropriate -- the indication for which the drug has conditional approval in the EU. According to IQWiG, Roche did not submit relevant data. Germany's Federal Joint Committee (G-BA) had requested that Roche compare Erivedge to radiotherapy in BCC patients ineligible for surgery and to surgery in BCC patients ineligible for radiotherapy. For patients ineligible for both, G-BA requested Roche compare Erivedge to best supportive care. The pharma submitted data from four single-arm trials evaluating Erivedge and submitted only historical data for best supportive care, which IQWiG said was not suitable. Comments are due Dec. 6; a final assessment from G-BA is expected in early February 2014. ...