FRANKFURT Jan 2 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
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
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
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.