NICE now backs Tecfidera in RRMS subgroup

The U.K.'s NICE issued a final appraisal determination (FAD) recommending Tecfidera dimethyl fumarate from Biogen Idec Inc. (NASDAQ:BIIB) to treat relapsing-remitting multiple sclerosis (RRMS) in a subgroup of patients who do not have highly active or rapidly evolving severe RRMS. In draft guidance issued in February, NICE said it was "minded not to recommend" Tecfidera for RRMS -- its approved indication. Biogen Idec subsequently submitted additional cost effective analyses, as well as results from the Phase III DEFINE and CONFIRM trials of Tecfidera adjusted for baseline relapse rate.

The subgroup recommendation is contingent on Biogen Idec providing Tecfidera at an undisclosed discount under a patient access scheme. The committee said there was insufficient evidence to recommend Tecfidera in highly active or rapidly evolving RRMS. ...