German HTA Assessment Knocks Back Gilenya In Europe
This article was originally published in The Pink Sheet Daily
IQWiG’s failure to find any added benefit from Novartis’ oral MS drug Gilenya in two out of three of its target patient groups, on the grounds of insufficient evidence, puts pressure on the drug following a similarly negative recommendation by U.K. cost-watchdog NICE at the end of 2011.
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The EMA recommended authorizing a single drug this month, GSK’s Mekinist, while giving the nod to seven others, including Novartis’ Gilenya and Boehringer Ingelheim’s Pradaxa.
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.
Germany’s new early-benefit assessment system for all new drugs launched since Jan. 1, 2011, radically changes the status of Europe’s largest market. It was once a bastion of free (and thus relatively high) pricing, which firms used to signal their drugs’ value to other markets. Now, prices of new drugs will be negotiated between sponsors and the country’s association of statutory sick funds, on the basis of an added-benefit score determined by the G-BA, or Federal Joint Committee. Since those net prices will be made public, and many other countries reference German prices, there’s a real risk of a downward price spiral across Europe.