NICE issues positive draft FAD guidance on Tecfidera

11 July 2014

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK