Bayer and Regeneron's hard-charging eye drug has traded its way to another victory. It won a recommendation from the U.K.'s cost-effectiveness watchdogs, on the strength of a pricing discount. Previously rejected as too expensive, Eylea is now in line for routine use by Britain's National Health Service.
If the National Institute for Health and Care Excellence (NICE) does adopt the proposed guidance in August, as expected, that will set up a head-to-head competition in the U.K. with Lucentis, another treatment for wet age-related macular degeneration, marketed by Novartis ($NVS). Lucentis was also approved by NICE only after the Swiss drugmaker extended a discount offer. And as PM Live notes, Eylea and Lucentis will be on equal footing approval-wise, because NICE set similar criteria for patients' eligibility for both treatments.
Regeneron ($REGN) has reaped a full load of sales from Eylea since its FDA approval in November 2011. Last year, Eylea delivered $837.9 million in net sales to the company, which holds its U.S. rights. The drug handily outstripped initial estimates, and performed so well that it helped top Regeneron executives qualify for $140 million in 2012 compensation.
Bayer HealthCare is a little behind that schedule, having launched Eylea in the U.K., Germany, Switzerland, Japan and a few other countries during the fourth quarter of last year. Its sales for 2012, then, amounted to €14 million, or about $18 million. NICE's backing would be a nice boost; besides offering access to the National Health Service's patients, the approval could inspire other countries that follow NICE's decisions to adopt Eylea as well.
Meanwhile, Lucentis got a welcome new backing from the European Medicines Agency. Its drug-review committee recommended a new indication in patients with myopic choroidal neovascularization. And Lucentis has two other indications backed by NICE, for patients with diabetic macular edema and macular edema caused by retinal vein occlusion.
- get the NICE statement
- see the PM Live story
- read the Novartis release
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