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NICE green light for Biogen’s oral MS drug

Overturns previous negative guidance for Tecfidera
Biogen Idec building

UK patients with multiple sclerosis (MS) are set to have another oral treatment option following last week's recommendation for Biogen Idec's Tecfidera.

The National Institute for Heath and Care Excellence (NICE) issued a final appraisal determination backing the use of Tecfidera (dimethyl fumarate) in adults with relapsing-remitting multiple sclerosis (RRMS).

The decision comes after previous negative guidance from health watchdog NICE, which claimed that the drug was not a cost-effective option for the NHS in England and Wales.

However, Biogen managed to change NICE's mind partly due to a patient access scheme whereby Biogen will cover part of the cost of the drug. NICE also revised Tecfidera's guidance so the drug cannot be used in patients with highly active or rapidly evolving severe RRMS.

The decision means that Tecfidera is set to become the third oral MS drug recommended by NICE, joining Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide).

Both these treatments also struggled to get through NICE's appraisal process, only succeeding once Novartis and Sanofi agreed a patient access scheme.

Gilenya was the first oral MS drug to hit the European market in 2012, and it has since managed to establish itself as a leading product for RRMS, placing in the top 50 pharmaceutical products for 2013.

Both Aubagio and Tecfidera only launched this year in the EU, although both are set to make inroads in a growing MS market. In the UK alone, about 100,000 people have MS and 50 to 60 people each week are diagnosed with the disease, according to the Multiple Sclerosis Trust.

Tecfidera would have hit the European market earlier but Biogen faced a court battle, which the company won, to classify the drug's active ingredient as a New Active Substance, strengthening its patent protection.

Article by
Thomas Meek

14th July 2014

From: Sales

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