Bayer's hot-selling Eylea runs into a roadblock in its home market

Sales of Bayer's Eylea have taken off since the EU greenlighted the eye drug in late in 2012. But now, Germany's cost watchdog has thrown up a roadblock for the second time. Thursday, the German Institute for Quality and Efficiency in Health Care (IQWiG) said it was unable to assess whether Eylea provided an advantage over its rival, Novartis' ($NVS) Lucentis--an opinion that could hurt sales for Bayer on its home turf.

Under the country's much-maligned pricing rules, new treatments must prove superior to existing competitors in order to command top dollar. But as Reuters reports, IQWiG said the way in which the macular edema drugs were administered during trials--neither was administrated in the way regulators specified when they approved Eylea for use in Germany--prevented it from drawing a conclusion.

As the news service notes, the opinion could affect the level of reimbursement patients receive from public insurers in Germany. The country's medical cost-benefit agency takes those opinions into consideration, and that agency is set to publish an analysis of Eylea within the next three months. Bayer said it would issue a response to the statement within the next three weeks, Reuters said.

Germany's pricing formula, rolled out in 2011, met with ire from drugmakers that has far from subsided. Since then, pricing frustrations have driven some pharma companies to pull their products from the German market, as AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) did in December with diabetes drug Forxiga. Others have simply not released their new products there at all.

And for some companies, frustration may seem justified. Eylea has come before IQWiG before, as a treatment for wet age-related macular degeneration, and couldn't show itself superior to Lucentis based on what a company spokesperson at the time called a technicality. "The main reason for [IQWiG's] conclusion of no additional benefit is the fact that the current label of Lucentis has never been studied in a clinical trial," Bayer's spokesperson told PMLiVE in May.

Elsewhere, Eylea has not exactly wanted for revenue. The drug hauled in €122 million ($165 million) for Bayer, which markets it in all countries outside the U.S., in the first half of 2013; the company has said it expects up to €1 billion in peak annual sales. And in the U.S., where Regeneron ($REGN) is responsible for marketing, Eylea has put up impressive numbers, including $643.7 million in first-half 2013 sales.

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