NICE issues positive draft FAD guidance on Tecfidera

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued the Final Appraisal Determination (FAD) today for US biotech firm Biogen Idec’s (Nasdaq: BIIB) new oral multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate).

The FAD indicates that NICE will be recommending Tecfidera as an option for treating adults with relapsing-remitting multiple sclerosis (RRMS) – normally defined as two clinically significant relapses in the previous two years – only if, they do not have highly active or rapidly evolving severe RRMS. Tecfidera will be provided under a patient access scheme.

The final step of the appraisal process is for NICE to issue the completed Technology Appraisal Guidance (TAG) over the coming weeks, after which time the NHS will have a three month period to implement the guidance.