NICE has published final guidance on aflibercept solution for injection (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.
This positive final 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. The NHS in England and Wales has 90 days to implement this guidance to ensure that all eligible patients have access to EYLEA as soon as possible.
Professor Sobha Sivaprasad, Consultant Ophthalmologist, Moorfields Eye Hospital and King’s College Hospital London commented: “For other eye conditions, such as wet AMD, EYLEA has already allowed us to achieve positive visual outcomes in real-life clinical practice, reflective of those seen in the pivotal clinical trials. To achieve these results in over-burdened NHS eye clinics is impressive and is mainly down to its simple dosing schedule that allows us to deliver treatment in a fashion as close to the clinical trial protocol as possible. It is therefore great news that we now have the opportunity to achieve similar results for people with visual impairment due to DMO; a patient group that is on the rise and already having to manage numerous appointments for their diabetes alongside their busy day to day lives.”
Within the 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.”
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.
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.
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.
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. 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.
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. The SMC also accepted it for restricted use for the treatment of visual impairment due to DMO in November 2014.
EYLEA was also licensed for visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) in February 2015.