The UK’s NICE has become the first to turn down Biogen Idec’s Tecfidera treatment for Multiple Sclerosis. The drug, which has sold well in the US so far, was approved by the European commission earlier this month. But the the National Institute for Health and Care Excellence, the quality and cost watchdog for the UK’s National Health service (NHS), has rejected Tecfidera on the basis of its steep £16,000 ($26,6800) yearly price tag.
This is perhaps unsurprising given the economic austerity gripping the EU. And given the NHS’s appetite for overspending it was perhaps almost inevitable.
But there is hope yet for Biogen Idec as NICE have given them until the 12th of March to return with additional data and information which could demonstrate the cost effectiveness of their treatment.
If the US market is anything to go by Biogen Idec may already have a strong case. Since it’s approval in the US back in March 2013 Tecfidera has exceeded the expectations of the industry. Last quareter the drug brought in $398 million for Biogen, more than $50 million about what analysts had predicted.
And this wouldn’t be the first time the NHS has backtracked on initial rejects for MS drugs. In the time it took Biogen Idec to sort itself out in the courts over the classification of Tecfidera’s API as a New Active Substance (in order to secure more generous patent protection), Novartis and Sanofi both entered the MS ring. Nice initially rejected both Novartis’ Gilenya and Sanofi’s Aubagio, but later approved the drugs after the developers had held discussions with NICE and secured a discount scheme for patients.