NICE approves Tecfidera (dimethyl fumarate)


Thousands of adults in England and Wales living with the most common type of multiple sclerosis may benefit from a new oral treatment, Tecfidera (dimethyl fumarate), as the National Institute for Health and Care Excellence (NICE) issues the Technology Appraisal Guidance (TAG).  

NICE has approved Tecfidera as an option for treating adults with active relapsing remitting multiple sclerosis – normally defined as two clinically significant relapses in the previous two years – only if, they do not have highly active or rapidly evolving severe relapsing remitting multiple sclerosis and the manufacturer provides Tecfidera with the discount agreed in the patient access scheme.


The NHS will have a three month period to implement the guidance.


Tecfidera is a new oral treatment, licensed for adult patients with relapsing remitting multiple sclerosis. Tecfidera is taken twice daily with food.


Eli Silber, consultant neurologist at the King’s Regional Neurosciences Centre, London, “I am pleased that our clinical trials team at King’s played a part in confirming the clinical benefits of Tecfidera and I am delighted that NICE has recognised the value of this new oral treatment. Multiple sclerosis is a long-term condition and it is important that patients who are newly diagnosed and starting treatment for the first time have access to new and efficacious treatments. In all multiple sclerosis treatments we are balancing clinically confirmed efficacy with side effects and the studies show that this new drug appears to have a very good risk-benefit profile.” 


Ben Turner, consultant neurologist and Honorary Senior Lecturer at Barts and The London NHS Trust says, “As the UK chief investigator for Tecfidera’s DEFINE study, having seen the obvious benefits of Tecfidera in multiple sclerosis patients I am delighted that people with relapsing-remitting multiple sclerosis will now have access to this new treatment. Tecfidera has been shown to significantly reduce the number of multiple sclerosis relapses and delay disability progression compared to placebo. Also, as shown in the studies, Tecfidera is well tolerated, making it a welcome new treatment option.”