German watchdog deals setback to Bayer eye drug Eylea
FRANKFURT Jan 2 (Reuters) - Bayer suffered a setback in its home market of Germany on Thursday when a healthcare cost watchdog said it was unable to assess whether its new eye medication Eylea offered an advantage over a rival product from Novartis.
The opinion issued by the German Institute for Quality and Efficiency in Health Care, or IQWiG, could affect the level of reimbursement by public insurers for Eylea in Germany.
IQWiG compared trial data on Eylea and Novartis's Lucentis for treatment of macular edema - a build-up of fluid under the centre of the retina following a blockage of the retina's major vein.
It said it was unable to assess whether Eylea was more effective than Lucentis, which is sold by Roche in the United States and by Novartis elsewhere, because in the trials neither drug was being administered in the way specified by regulators when it was approved for use in Germany.
IQWiG's opinions are taken into account by Germany's medical cost-benefit agency G-BA, which is due to publish an assessment of Eylea's cost-effectiveness within the next three months. Bayer said it would respond to IQWiG's statement within three weeks.
Bayer has said it expects Eylea, also known as VEGF Trap-Eye, to generate more than 1 billion euros ($1.4 billion) in peak annual sales. Bayer HealthCare and Regeneron Pharmaceuticals are collaborating in Eylea's development.
IQWiG also said Bayer's cancer treatment Stivarga, another potential blockbuster drug, had advantages over alternative treatment, albeit minor ones.
While trials did show that Stivarga helped cancer patients live longer, the treatment also carried frequent, severe side-effects, it said.
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