NICE’s Tecfidera Restrictions In MS Leave It Fighting For U.K. Market Share
This article was originally published in The Pink Sheet Daily
Biogen Idec get nod after providing more data, but restrictions imposed mean Tecfidera is unlikely to leap ahead of a packed field.
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Genzyme had a mixed few days with its MS drugs at NICE, with Aubagio finally succeeding but Lemtrada struggling on the back of a tough benefit/risk profile.
The company expects dimethyl fumarate’s strong efficacy and favorable safety and tolerability profile to be an advantage against other oral multiple sclerosis drugs.
It is becoming ever more clear that the overriding factor in NICE’s decision-making process is a desire to see cost-effectiveness, irrespective of the clinical benefit of a drug. But in Germany, companies are challenged by IQWiG’s tightened-up, science-based review system.