NICE recommends EYLEA for visual impairment due to diabetic macular oedema (DMO)

The National Institute for Health and Care Excellence (NICE) draft Final Appraisal Determination (FAD) recommends EYLEA for the treatment of patients with visual impairment due to diabetic macular oedema (DMO); a condition that affects approximately 50,000 people in the UK^1,2

Bayer HealthCare is pleased to announce that NICE has recommended EYLEA® (aflibercept solution for injection) for the treatment of visual impairment due to diabetic macular oedema (DMO).¹ This positive draft FAD decision means that people in England and Wales with DMO and a central retinal thickness of 400 micrometers or more will now have access to an additional effective treatment option that offers them a clearly defined treatment plan.¹

Miss Sobha Sivaprasad, Consultant Ophthalmologist, Moorfields Eye Hospital and King's College Hospital London commented: "DMO is set to increase significantly as the number of people with diabetes grows, so it is vital that we have effective treatment options available that fit in with the lives of patients already managing numerous appointments for their diabetes. EYLEA, with its simple treatment plan, has already enabled doctors to deliver positive visual outcomes for other conditions in real-life clinical practice, similar to those seen in clinical trials. It is therefore great news that we are now able to offer it to DMO patients to hopefully achieve similar outcomes."

Within the draft FAD, NICE recognised the benefits of the simple dosing regimen with EYLEA stating that "The Committee heard [from patient experts] that patients having anti-VEGF treatments find fixed treatment appointments helpful, particularly those patients who are in employment or who have childcare or elderly caring responsibilities. The Committee concluded that loss of vision caused by DMO impairs quality of life and additional treatment options would be of value to patients and their carers."¹

Commenting on the announcement, Dr Alexander Moscho, Bayer UK/Ireland CEO said: "We are pleased that NICE has recognised the difference that EYLEA can bring to people with visual impairment due to DMO and to NHS eye services. The wealth of evidence from NHS clinical practice and ongoing clinical trials continue to cement this treatment as a valuable option for patients with serious retinal conditions and we hope that the real-life visual outcomes seen in other indications can now be replicated for people with DMO."

EYLEA needs to be given by a trained physician and treatment starts with one injection per month for five consecutive doses, followed by one injection every two months without the need to visit the hospital for monitoring between injections. After the first 12 months of treatment, the time between injections may be extended based on how well the treatment is working.³

The licence for EYLEA for the DMO indication was granted in August 2014 based on data from the pivotal VIVID-DME and VISTA-DME studies which showed that it is capable of delivering sustained visual acuity gains compared to laser photocoagulation after two years of receiving EYLEA 2 mg every other month, after five initial monthly injections. In the VIVID-DME study, the mean gain from baseline for best corrected visual acuity (BCVA) was 9.4 letters (10.7 letters at one year; p<0.0001) with EYLEA and 0.7 letters (1.2 letters at one year; p < 0.0001) with laser photocoagulation. In the VISTA-DME study, the mean gain from baseline for BCVA was 11.1 letters (10.7 letters at one year) with EYLEA and 0.9 letters (0.2 letters at one year) with laser photocoagulation.^4,5

In both studies, EYLEA was well tolerated with a similar overall incidence of adverse events (AEs), serious ocular (relating to the eye) AEs, and serious non-ocular (not relating to the eye) AEs compared to laser photocoagulation. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME studies included conjunctival haemorrhage, eye pain, and floaters in the eye. The most frequent non-ocular TEAEs included hypertension and cold symptoms. Arterial thromboembolic events (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates with EYLEA compared to laser photocoagulation.^4-9

This is the third positive NICE recommendation for EYLEA. It received its first NICE recommendation for wet age-related macular degeneration (wAMD) in July 2013¹⁰ and the second recommendation for visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) in February 2014.¹¹ Funding for EYLEA is now mandated across England and Wales for the treatment of eligible patients with wAMD and visual impairment due to macular oedema secondary to CRVO.^10,11

Once the draft FAD for the treatment of visual impairment due to DMO is made final, expected at the end of June, the NHS will have 90 days to make EYLEA available to all eligible patients with this condition.

The Scottish Medicines Consortium (SMC) accepted EYLEA for the treatment of wet AMD in April 2013¹² and visual impairment due to macular oedema secondary to CRVO in April 2014.¹³ The SMC also accepted it for restricted use for the treatment of visual impairment due to DMO in November 2014.¹⁴

About diabetic macular oedema (DMO)

DMO, a serious eye condition affecting people with diabetes, is the commonest cause of preventable blindness among people of working age.¹⁵ The number of people with DMO is set to increase significantly with the expected growth of the diabetes population, adding to what is already a major public health issue.¹⁶

DMO occurs in some patients that have diabetic retinopathy, a complication of diabetes. DMO occurs when fluid leaks from damaged blood vessels beneath the macula, a small part of the retina at the back of the eye, and results in the distortion of central vision where straight lines appear crooked or wavy.¹⁷

Many people with diabetes struggle to manage the numerous hospital visits required to manage all aspects of their condition, particularly as they need to miss work on a regular basis.¹⁸ This can lead to patients missing vital appointments to monitor their condition and other potential complications such as diabetic eye screening.

If not diagnosed and treated effectively, DMO can result in vision loss and this can have an impact on the day-to-day lives of patients and their families. It can jeopardise financial security, due to the loss of employment and dependence on benefits, and impact a patient's psychological well-being due to depression and social isolation.¹ It is therefore vitally important that this disease is diagnosed and treated early to minimise its impact on a patient's health and well-being.

About EYLEA

EYLEA (aflibercept solution for injection) is made up of two human proteins fused together to interfere with two growth factors, vascular endothelial growth factor - A (VEGF-A) and placental growth factor (PlGF). These growth factors affect the blood vessels beneath the macula by increasing inflammation and fluid leakage (macular oedema) and promoting the growth of abnormal and fragile blood vessels. By interfering with these growth factors aflibercept blocks their effect on blood vessels beneath the macula, preventing further damage to sight.³