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NICE rebuffs Zelboraf

June 15, 2012 12:29 AM UTC

The U.K.'s NICE does not think Zelboraf vemurafenib from Roche (SIX:ROG; OTCQX:RHHBY) is cost-effective in treating unresectable or metastatic melanoma in patients with BRAFV600 mutations. The committee said in draft guidance that there was "considerable uncertainty" about the magnitude and duration of Zelboraf's effect on survival because many of the patients in the Phase III BRIM3 trial who were receiving dacarbazine were moved to other treatments when their disease progressed, making comparison difficult. NICE said even with an undisclosed discount under a patient access scheme, the most plausible incremental cost-effectiveness ratio (ICER) for Zelboraf would be "considerably higher" than L50,000 ($77,510) per quality-adjusted life-year (QALY) gained compared with dacarbazine. Comments are due July 7. ...