IQWiG gives Zelboraf positive assessment

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said Zelboraf vemurafenib from Roche (SIX:ROG; OTCQX:RHHBY) provides "significant" additional benefit over dacarbazine for patients with unresectable or metastatic melanoma who are BRAF V600-mutation positive. The agency said Zelboraf's "major" improvements in overall survival (OS) over the comparator outweigh an increased incidence of serious adverse events.

Roche has until July 6 to respond to the preliminary benefit assessment. The Federal Joint Committee (G-BA) will then review IQWiG's recommendations and issue a final benefit assessment, which is expected in early September. Pricing and reimbursement negotiations would begin after G-BA's final assessment. ...