NICE green light for Eylea
pharmafile | May 31, 2013 | News story | Sales and Marketing | Bayer, NICE, Regeneron
NICE has recommended Bayer’s injection Eylea as a treatment for neovascular (wet) age-related macular degeneration (AMD) if the manufacturer offers it under a confidential patient access scheme.
Eylea (aflibercept) was approved in Europe last year at a 2mg dose, with injections every other month – a crucial improvement in convenience for patients – after three monthly ones to start with.
Current treatments include Novartis’ monthly injection Lucentis (ranibizumab) – and Eylea can only be used in line with NICE’s recommendations on that drug.
Final guidance from NICE on Eylea is expected in August, although there will not be a public consultation – because it has been recommended in line with its licensed indication – which means approval is likely to be speeded up.
Wet AMD involves new blood vessels growing and leaking blood and fluid affecting the macula, which is part of the retina, and causing problems with central vision, although it does not lead to total blindness.
“Wet AMD can have a significant effect on day-to-day life for people with the disease,” said NICE chief executive Sir Andrew Dillon. “The independent Committee concluded that the recommendations can go straight to a final draft.”
NICE says Eylea can be used if the area affected by AMD is no larger than 12 times the size of the area inside the eye where the optic nerve connects to the retina, and if there are signs that the condition has been getting worse.
A 40 mg/ml solution for injection costs £816 per 100-microlitre vial, excluding VAT, and NICE found Eylea had lower costs and QALYs than Lucentis and could be recommended as a cost effective drug if Lucentis would otherwise be the treatment used.
The European green light for Eylea was based on positive results from two Phase III trials: VIEW 1 and VIEW 2 showed various doses, including the 2mg one, were as good as the standard 0.5mg monthly injection of Lucentis.
Bayer has developed Eylea with Regeneron, the latter holding exclusive US rights while Bayer has the rights for every other country.
Both companies share profits equally – except in Japan – and Regeneron will receive a royalty on net sales. Analysts have predicted Eylea could hit peak sales of $2 billion.
It is thought that over 80% of visual impairment from conditions such as wet AMD is preventable, which makes extra indications potentially lucrative.
Bayer has also completed Phase III trials with Eyelea in macular edema following central retinal vein occlusion (CRVO), and they are ongoing in diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV).
Adam Hill
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