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NICE turns down Biogen Idec’s oral MS drug

UK HTA body says Tecfidera is not a cost-effective use of NHS resources
Biogen Idec building

The National Institute for Health and Care Excellence (NICE) has rejected the routine use of Biogen Idec's oral multiple sclerosis (MS) treatment Tecfidera in draft guidance.

NICE, which assesses the value of drugs for use on the NHS in England and Wales, said that Tecfidera (dimethyl fumarate) was not a cost-effective use of NHS resources to treat adults with relapsing-remitting MS; when used as recommended a year's treatment costs more than £16,000.

The organisation's chief executive Sir Andrew Dillon justified the provisional NICE guidance, explaining there were “still questions to be answered about the clinical and cost effectiveness of the drug” in the proposed indication. As such, NICE has requested more details from Biogen Idec.

“We want to ensure that we have as much information as possible to make an informed final recommendation,” said Sir Andrew.

Biogen Idec now has until March 12 to submit this extra information after which NICE will produce further guidance, with an aim to make a final recommendation in the summer of 2014.

Tecfidera was only approved in the EU at the beginning of this month, almost one year after it was recommended by the European Medicines Agency (EMA). The delay was down to a court battle, which Biogen Idec won, to classify the drug's active ingredient as a New Active Substance, strengthening its patent protection.

The delay has allowed the two other new oral relapsing-remitting MS drugs – Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide) – to establish their own presence in the European market by offering a simpler regimen than previous injectable treatments.

Both Gilenya and Aubagio also faced a struggle to win a NICE recommendation, with Novartis and Sanofi receiving rejections in early draft guidance.

However, NICE later reversed its negative decision on both products after consultation with Novartis and Sanofi and a discount on each drug through a patient access scheme.

Speaking to PMLiVE, a Biogen Idec spokesperson asserted that this guidance was an interim step in the NICE process, and that Aubagio and Gilenya had faced a similar situation.

The spokesperson also confirmed that Biogen Idec was looking to discuss the draft guidance with NICE and was intending to collaborate with the agency on getting access to market for Tecfidera in MS patients.

This includes the possibility of a patient access scheme, with Biogen Idec in discussions with local authorities.

Article by
Thomas Meek

21st February 2014

From: Sales

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