The National Institute for Health and Care Excellence has recommended Bayer’s Eylea as an option for diabetic macular oedema in preliminary recommendations, having agreed a discount with the company.

The cost-watchdog is backing Eylea (aflibercept) in people where the eye has a central retinal thickness of 400 micrometres or more at the start of treatment. Carole Longson, health technology evaluation centre Director at NICE, said the agency is happy to recommend the vascular endothelial growth factor (VEGF) inhibitor, not least because Bayer has agreed a patient access scheme “which reduces the financial burden of aflibercept on the NHS”.  

DMO is caused when blood vessels abnormally form under the retina and then begin to break down causing plasma to leak into the eye. It can lead to severe visual impairment.

Eylea is administered as a single 2mg intravitreal injection and the list price is £816.00 per vial. It will compete with Novartis' Lucentis (ranibizumab), which was approved by NICE in April 2013; final guidance is expected to be published in June.

The response from Bayer has been mixed. The company says it is pleased NICE has recognised the benefits of Eylea in this indication  but is disappointed that a core group of patients diagnosed with early-stage DMO (central retinal thickness less than 400 micrometres) would be denied treatment until their disease has progressed “to a stage where permanent damage to the eye has already begun”.

‘Frustating’

Bayer quoted Sobha Sivaprasad of Moorfields Eye Hospital as saying it is “frustrating that whilst we are able to diagnose the disease early through the diabetic retinal screening programme we are still unable to effectively treat patients until their DMO progresses. The level of vision in patients who are diagnosed early tends to be good and prompt treatment will help maintain this vision”.

Dr Sivaprasad added that another treatment option available for those with early-stage DMO includes laser therapy “which is not very effective and can even lead to deterioration of vision, meaning the decision is often made to leave patients and monitor them for disease progression until they can receive alternative treatment options”.

Bayer said it will work with NICE throughout the appraisal process “to ensure all DMO patients have access to Eylea” when the decision is finalised in June.

Eylea was recommended for wet age-related macular degeneration by NICE in July 2013 and for visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) in February 2014.