The German pricing watchdog IQWiG says it sees no additional benefit from Eylea in comparison to Novartis’s drug in wet age-related macular oedema.

In a preliminary assessment, the IQWiG – Germany’s equivalent of NICE – has said that Bayer/Regeneron’s new wet AMD drug Eylea is no better than Novartis’ established treatment Lucentis.

IQWiG also did not accept the argument that Eylea led to a reduction in necessary injections and consequent reduction in related side effects (e.g. eye inflammation), which was based on an “unpublished mathematical simulation”.

The institute said the data Bayer submitted comparing Eylea and Lucentis were “not suitable” because Lucentis was not administered according to its European label.

In the Phase III VIEW1 and VIEW2 trials, patients in the Lucentis arm continued to receive the drug regardless of whether they had reached maximum visual acuity. Lucentis’ European label notes that it is to be given monthly until a patient reaches maximum visual acuity, defined as three consecutive months of stable visual acuity.

Bayer said it will respond to the assessment by the 5 April deadline. A final assessment from the German healthcare pricing authority, the G-BA, is expected in early June.

Eylea success

Eylea, which is marketed in the USA by Regeneron and in Europe by Bayer, has racked up impressive sales of $838 million last year, after only being on the US market since late 2011.

Eylea has not only assumed market share at the expense of Lucentis, which made just over $1 billion in peak sales last year, but also off-label use of Roche’s cancer drug Avastin, which is 37-times cheaper than Eylea.

Analysts at Barclays suggest that IQWiG will likely view the efficacy of Eylea on a par with Lucentis, which should allow for a “comfortable” price in Germany.

Since 2011 pharma products entering into Germany have been subject not only to IQWiG, but also the new AMNOG pricing structure.

This six-tier structure determines how much extra benefit a drug can give next to its nearest comparator. If it is better, then the pharma company can negotiate a price with the German Government, if not, then a basic price will be set, generally much lower than the company would hope for.

Bayer will now have to work hard to convince the Germany pay masters of its drugs’ efficacy over Lucentis if it is so gain a good price in Europe’s biggest pharma market.