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Top-selling AMD drug runs into a roadblock in its home market

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 oeda 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.The opinion could affect the level of reimbursent 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 statent within the next three weeks.Germany’s pricing formula, rolled out in 2011, met with ire from drug makers that has far from subsided. Since then, pricing frustrations have driven some pharmaceutical companies to pull their products from the German market.Eyelea 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 said in May.Elsewhere, Eylea has not exactly wanted for revenue. The drug hauled in euro 122 million ($165 million) for Bayer, which markets it in all countries outside the United States in the first half of 2013; the company has said it expects up to euro 1 billion in peak annual sales. And in the US, where Regeneron is responsible for marketing, Eylea has put up impressive numbers, including $643.7 million in first-half 2013 sales.

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