NICE Turns Back and Approves Biogen’s Oral MS Drug Tecfidera in the UK

The UK’s National Institute for Health and Care Excellence (NICE) gave a positive final appraisal determination to the use of the Biogen Idec‘s drug Tecfidera (dimethyl fumarate) in adults for the treatment of relapsing-remitting multiple sclerosis (RRMS), having turned back on their preliminary negative recommendation. The oral therapy, which was already approved in the United States, may now offer a new alternative for patients suffering from the disease in England and Wales.

NICE had rejected the use of Tecfidera in a draft guidance because it was not cost-effective, as a recommended year of treatment would cost about $27,500. The institution asked Biogen for more information about the clinical and cost effectiveness of the drug, and the two parties were able to reach a patient access scheme whereby Biogen will cover part of the cost of the drug, leading NICE to change its judgement.

Biogen also revised Tecfidera’s guidance so that it cannot be administrated to patients with highly active or rapidly evolving severe RRMS. The drug has been proven to significantly reduce important measures of disease activity, including relapses, development of brain lesions, and to slow disability progression over time, as well as it demonstrated a favorable safety and tolerability profile.

With this decision, Tecfidera becomes the third oral MS drug to be recommended by NICE. The other two are Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide), which also struggled to get through NICE’s appraisal process, and also had to agree to a patient access scheme. Tecfidera is also approved in Canada, Australia, and the European Union.

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Similarly to what happened to Tecfidera, Aubagio was only approved in the EU in 2014. Gilenya, on the other hand, has been established since 2012 as one of the leading products for RRMS in the region. In the UK alone, about 100,000 people suffer from the disease, and there are 50 to 60 new diagnoses each week.

Biogen only introduced Tecfidera in the European market this year because the company was facing a longstanding battle to secure market exclusivity for its oral MS drug. The company ended up winning the case, and the main active ingredient of Tecfidera was officially named a New Active Substance, strengthening its patent protection. Biogen delayed the introduction of the drug while it was not resolved, but now has 10 years of regulatory exclusivity.