Biogen Idec has received a boost with the news that the cost watchdog in England and Wales has recommended use of its high-profile multiple sclerosis pill Tecfidera, a few months after it was “minded to say no”.
The National Institute for Health and Care Excellence has issued its Final Appraisal Determination, recommending Tecfidera (dimethyl fumarate) as an option for treating adults with relapsing-remitting MS – normally defined as two clinically significant relapses in the previous two years – if they do not have highly active or rapidly evolving severe RRMS.
NICE have not recommended Tecfidera for those with highly active or rapidly evolving RRMS for whom other treatments are available , notably Sanofi's Lemtrada (alemtuzumab), Biogen's own Tysabri (natalizumab) and Novartis' pill Gilenya (fingolimod).
The guidance represents a U-turn on NICE's decision to not recommend Tecfidera made in the previous draft consultation document in February. Then, NICE chief executive Sir Andrew Dillon said the agency's independent appraisal committee had concluded that there were still questions to be asked about the clinical and cost-effectiveness of the drug.
Priced at £17,900 per year
Biogen says Tecfidera will be provided under a patient access scheme and notes that the final step of the appraisal process is for NICE to issue the completed Technology Appraisal Guidance over the coming weeks. After that, the NHS will have a three-month period to implement the guidance; the price is slated at £17,900 per year.
Terry O’Regan, managing director of Biogen UK & Ireland, said the firm is delighted that people in England, Wales and Northern Ireland living with the most common form of MS will soon have access to Tecfidera. He added that the company is “proud that we are able to bring this first-line cost-effective oral treatment to market with proven efficacy demonstrated through a robust clinical trials programme”.
Approximately 100,000 people in the UK have MS and between 50-60 people are diagnosed each week.
UPDATE: Nick Rijke, director for policy and research at the MS Society, said: "We’re delighted that NICE has finally approved Tecfidera after their initial negative review of the drug earlier this year. It’s the third new drug to be approved for people with relapsing remitting MS over a number of months so today marks a significant step forward in the treatment of the condition”.
He added that the drug “is proven to be safe and effective in treating MS and for many people it will be much easier to live with because it’s taken in a pill form”. Tecfidera was approved in Europe in February following a stellar performance in the USA since its approval in March last year.