The National Institute for Health and Care Excellence (NICE) has published final guidance recommending aflibercept solution for injection (Eylea, Bayer) as an option for treating visual impairment caused by macular oedema, a condition which affects a person's ability to see detail and colour. The guidance relates to macular oedema secondary to central retinal vein occlusion (CRVO), where the vein to the retina is blocked. NICE recommends the treatment is only prescribed if the manufacturer makes it available to the NHS under terms agreed with the Department of Health as part of a patient access scheme.

The macula is the central part of the retina at the back of the eye. When a retinal vein becomes blocked (retinal vein occlusion) blood cannot drain away from the retina and can leak into the macula causing it to swell. This is known as macular oedema and, because the macular is responsible for seeing colour and fine detail, macular oedema can cause straight lines to appear wavy, and people with the condition can have blurred central vision or sensitivity to light.

Aflibercept is given by injection into the eye. It works by blocking the growth of the abnormal blood vessels at the back of the eye.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "Macular oedema can have a significant impact on the independence and day-to-day life for people with the condition, affecting their ability to work, drive, and take part in hobbies such as reading and going to the cinema. Therefore NICE is pleased to recommend aflibercept solution as another clinically and cost-effective treatment option for people with macular oedema caused by central retinal vein occlusion as well as ranibizumab and dexamethasone, which NICE has already approved for this condition."

The final guidance is available on the NICE website.

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Notes to editors

About the guidance

1. Aflibercept solution for injection (Eylea, Bayer) is a vascular endothelial growth factor (VEGF) inhibitor. It prevents the inappropriate growth of new blood vessels in the retina. Aflibercept solution for injection has a UK marketing authorisation for 'the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO)'.

2. Aflibercept is administered as a single 2-mg intravitreal injection. Each vial of aflibercept contains 4 mg in 0.1 ml, providing a usable amount to deliver a single dose of 0.05 ml containing 2 mg of aflibercept. After the initial injection, treatment is given monthly. The summary of product characteristics states that the interval between 2 doses should not be shorter than 1 month. If there is no improvement in visual and anatomic outcomes over the course of the first 3 injections, continued treatment is not recommended. Monthly treatment continues until visual and anatomical outcomes are stable for 3 monthly assessments. Thereafter the need for continued treatment should be reconsidered. The summary of product characteristics states that monitoring is recommended at the injection visits and that the monitoring schedule should be determined by the doctor responsible for the patient's care based on the response of the condition to treatment.

3. The list price of aflibercept 40 mg/ml solution for injection is £816 per 100-microlitre vial (excluding VAT; 'British national formulary' [BNF] edition 66).

4. The clinical evidence from the COPERNICUS and GALILEO trials, which compared aflibercept with sham injection, showed that aflibercept was associated with a greater proportion of eyes gaining 15 or more letters from baseline to 24 weeks than sham injection. The Committee accepted the results from the manufacturer's network meta-analysis. This showed that there is no statistically significant difference in the odds or relative risk of gaining 15 or more letters from baseline to 24 weeks for the comparison of aflibercept with ranibizumab, and that the odds and relative risk of gaining 15 or more letters from baseline to 24 weeks was statistically significantly smaller with dexamethasone compared with aflibercept.

5. The Committee noted that the manufacturer's base-case analysis showed that aflibercept dominated ranibizumab (that is, it was more effective and less costly), resulting in more QALYs and lower costs. The Committee considered the uncertainties in the manufacturer's model and noted the ERG's changes to the manufacturer's model which resulted in slightly improved estimates of overall cost savings with aflibercept.

6. The Committee noted that the ERG's exploratory analysis, which included the confidential discount applied to the list price for aflibercept, resulted in an ICER of £12,300 per QALY gained for aflibercept compared with dexamethasone. The Committee also noted that even in the ‘worst case scenario', the ICER was below the top end of the range that would normally be considered a cost-effective use of NHS resources (£20,000-30,000 per QALY gained).

7. The manufacturer of aflibercept has agreed a patient access scheme with the Department of Health. This involves a discount applied to the list price of aflibercept solution for injection. The level of the discount is commercial-in-confidence.

8. NICE technology appraisals apply across the NHS in England.

9. Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication.

10. For further details on NICE technology appraisals, please see the NICE website.

11. The Scottish Medicines Consortium has yet to issue advice on aflibercept solution for injection (Eylea, Bayer) for visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO).

Related NICE guidance

Published

12. Ranibizumab for treating visual impairment caused by macular oedema secondary to retinal vein occlusion. NICE technology appraisal guidance 283 (2013).

13. Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion. NICE technology appraisal guidance 229 (2011).

About NICE

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