Novartis' Gilenya: Down But Not Out With NICE
This article was originally published in The Pink Sheet Daily
Novartis faces a setback in the U.K., as NICE refuses to recommend Gilenya to the NHS, citing lack of comparative data and cost.
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The EMA’s CHMP has given the nod to Sanofi’s Aubagio and Biogen Idec’s Tecfidera for multiple sclerosis, setting the scene for a European three-way battle with Novartis’ Gilenya in the coming months.
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.
NICE says that additional information provided by Novartis does not satisify its requirement for proof of cost-effectiveness of Gilenya.