NICE is recommending Bayer’s wet age related macular oedema drug Eylea in a speedy review published today.
In final draft guidance Bayer’s Eylea (aflibercept), which is marketed by Regeneron in the USA, is recommended as an option for treating wet age AMD if it used in the same manner as its rival drug Lucentis, developed by Novartis, and if it cuts the price of the drug under a confidential patient access scheme.
Eylea has been fast-tracked through the NICE appraisal process, missing out on the usual preliminary stages and jumping straight to final draft guidance, taking months off the process.
NICE said this was because the drug has been offered to NICE exactly in line with its licence, meaning the Institute did not need additional information. It also came with a price cut from the start, again making it easier for NICE to recommend.
The list price of Lucentis 40 mg/ml solution for injection is £816 per 100-microlitre vial, but this will be less due to the patient access scheme.
If approved in final guidance in August the drug will then be directly competing with Lucentis which has been available on the NHS since 2008.
Lucentis costs £761.20 per vial - but the firm lowered the cost of the drug last year, with its price tag is believed to be around 30% less than the above figure.
The two drugs have been competing for market share in the USA since Eylea was approved by the FDA in 2011. Despite coming second to market, Eylea has racked up impressive sales of $838 million last year, with Lucentis taking home just over $1 billion.Lucentis was approved for wet AMD in 2006, and also has several other ophthalmic licences to up its revenue, making Eylea's sales figures even more impressive.
But it has not all been positive news for the drug: in March IQWiG, the German equivalent of NICE, found that Lucentis “was no better” than Eylea. A final assessment from the German healthcare pricing authority, the G-BA, is expected at the beginning of next month.
The spectre of Avastin
Both drugs, however, will continue to face the artificial competition of Roche’s Avastin, a cancer drug that is being used off-licence for wet AMD as it has a similar mode of action to Lucentis. In fact it is because of the pricing pressure from Avastin, which can be used at a price 10 times lower than the licensed drug, that Novartis dropped its price for Lucentis last year.
Two comparison trials of the drugs are currently on-going by both the US and UK governments, with the latest data from the States indicating that Lucentis and Avastin are broadly similar in safety and efficacy. New data from the UK trial is expected to be published in July, although neither Roche nor Novartis have sanctioned the studies.