NICE gives aflibercept provisional green light for DME

The National Institute for Health and Care Excellence (NICE) has released a draft decision recognizing the benefits of aflibercept solution for injection (EYLEA, Bayer HeathCare) for the majority of patients with visual impairment caused by diabetic macular oedema (DME).

Bayer HealthCare said in a statement that although it is pleased by the NICE draft decision, it is disappointed that a core group of patients diagnosed with early stage DME (those with central retinal thickness of less than 400 mm) would be denied treatment until their disease has progressed to a stage where permanent damage to the eye has already begun. Bayer said it is committed to working with NICE throughout the appraisal process to ensure all DME patients have access to aflibercept when the decision is finalized.

“It is good news that we may potentially have [aflibercept] as a further effective treatment option for many patients experiencing visual impairment due to DME; however 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 DME progresses,” said Dr Sobha Sivaprasad, consultant ophthalmologist, Moorfields Eye Hospital and King’s College Hospital, London, UK. “The level of vision in patients who are diagnosed early tends to be good, and prompt treatment will help maintain this vision by preventing further damage due to DME.”

Aflibercept was licensed in the UK for the treatment of wet age-related macular degeneration (AMD) in November 2012 and was accepted by the Scottish Medicines Consortium (SMC) for this use within NHS Scotland in April 2013. It was recommended by NICE for the treatment of wet AMD on the National Health Service in England and Wales in July 2013.

Aflibercept was licensed in the UK for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) in August 2013, and NICE recommended it for this use in February 2014. It was accepted by the SMC for use within National Health Service for Scotland (NHS Scotland) for the treatment of visual impairment due to macular edema secondary to CRVO in April 2014. Funding for aflibercept is now mandated across England and Wales for the treatment of eligible patients with wet AMD and visual impairment due to macular edema secondary to CRVO. 

The UK licence for aflibercept for the treatment of visual impairment due to DME was granted in August 2014, with the SMC accepting it for restricted use in this indication in November 2014.

Aflibercept is made up of two human proteins fused together to interfere with two growth factors: vascular endothelial growth factor-A, and placental growth factor. By interfering with these growth factors, aflibercept blocks their effect on blood vessels beneath the macula, preventing further damage to sight.