The National Institute for Health and Care Excellence (NICE) has published final guidance recommending aflibercept solution for injection as an option for treating wet age-related macular degeneration (AMD).

Wet AMD is an eye condition that affects the macula (a tiny part of the retina at the back of the eye). AMD causes problems with central vision - for example, straight lines may appear wavy and blind spots may develop in the field of vision.

Macular degeneration is diagnosed as either dry (non-neovascular) or wet (neovascular). Neovascular refers to growth of new blood vessels in an area, such as the macula, where they are not supposed to be.

There are an estimated 26,000 new cases of wet AMD in the UK each year. Risk factors include increasing age, cigarette smoking (smokers having a 3.6 times greater risk of developing age-related macular degeneration compared with people who have never smoked), and exposure to high levels of UV light. It is also more common in women than men [i].

Aflibercept is recommended as an option for treating wet age related macular degeneration only if:

• it is used in accordance with the recommendations for ranibizumab in NICE technology appraisal guidance 155 [ii] (re-issued in May 2012), and
• the manufacturer provides aflibercept solution for injection to the NHS under the terms agreed with the Department of Health as part of a patient access scheme.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "Wet AMD can have a significant impact on vision, independence and quality of life. Today's guidance, which comes soon after aflibercept received its licence, provides healthcare professionals with clear advice on where and when this treatment can add value as another treatment option for those affected by this distressing condition. ”

This is NICE's final guidance on this technology and now replaces local recommendations across the country.

Ends.

Notes to editors

References and explanation of terms

[i] NICE scope for the appraisal of aflibercept solution for injection for the first-line treatment of wet age-related macular degeneration.

[ii] Ranibizumab is recommended as a possible treatment for people with wet AMD if all the following apply to their eye:

• The best possible visual acuity [iii] after correction with glasses or contact lenses is between 6/12 and 6/96.
• There is no permanent damage to the fovea [iv] (the part of the eye that helps people to see things in sharp detail).
• The area affected by AMD is no larger than 12 times the size of the area inside the eye where the optic nerve connects to the retina.
• There are signs that the condition has been getting worse.
• Treatment should be stopped if a person's vision gets worse and there are changes inside the eye which show that treatment isn't working.

For further detail, please see NICE Technology Appraisal 155.

[iii] The best-corrected visual acuity refers to the best possible vision a person can achieve with corrective contact lenses or glasses.

[iv] The central fovea is located in the centre of the macula region of the retina and is responsible for sharp central vision.

About the guidance

1. The guidance is available on the NICE website.
2. People currently receiving aflibercept solution for injection whose disease does not meet the criteria detailed above should be able to continue treatment until they and their clinician consider it appropriate to stop.
3. Aflibercept solution for injection (Eylea, Bayer Pharma) is a soluble vascular endothelial growth factor (VEGF) receptor fusion protein which binds to all forms of VEGF-A, VEGF-B, and the placental growth factor. Aflibercept solution for injection prevents these factors from stimulating the growth of the fragile and permeable new blood vessels associated with wet age-related macular degeneration. Aflibercept solution for injection has a UK marketing authorisation ‘for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD)'.
4. The summary of product characteristics states that the recommended dose for aflibercept is 2 mg and that treatment should be given monthly for 3 consecutive 2 mg doses, followed by 1 injection every 2 months. Each 100 microlitre vial contains 4 mg of aflibercept. Aflibercept solution for injection must only be administered by a qualified doctor experienced in administering intravitreal injections. The summary of product characteristics also states that there is no need for monitoring between injections. After the first 12 months of treatment, the treatment interval may be extended based on visual and anatomic outcomes. In this case, the schedule for monitoring should be determined by the treating doctor.
5. The list price of aflibercept 40 mg/ml solution for injection is £816 per 100-microlitre vial (excluding VAT; ‘British national formulary' [BNF] edition 52).
6. The Committee noted that its preferred analyses incorporated the confidential discount to the list price of aflibercept and a range of discounts (from 0 to 50%) to the list price of ranibizumab. It also noted that, when discounts to the list price of ranibizumab ranged from 0 to 45%, aflibercept had lower costs and quality-adjusted life years (QALYs) than ranibizumab, which resulted in ICERs for aflibercept compared with ranibizumab ranging from £1,692,500 to £16,700 saved per QALY lost and that, when a 50% discount was applied to the list price of ranibizumab, aflibercept was dominated by ranibizumab in both the worse-seeing eye and better-seeing eye model. However, the Committee was aware that, in both the manufacturer's and the ERG's analyses, the differences in total costs and QALYs were very small. The Committee therefore concluded that aflibercept could be recommended as a cost effective use of NHS resources if ranibizumab would otherwise be the treatment used.
7. The independent Appraisal Committee decided that an appraisal consultation document (ACD) was not needed for this appraisal, so the recommendations went straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licensed indication.
8. The manufacturer of aflibercept has agreed a patient access scheme with the Department of Health. This involves a confidential discount applied to the list price of aflibercept solution for injection. The level of the discount is commercial-in-confidence.
9. NICE technology appraisals apply across the NHS in England and Wales.
10. 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.
11. Further details on NICE technology appraisals.

Related NICE guidance

Published

1. Epiretinal brachytherapy for wet age-related macular degeneration. NICE interventional procedure guidance 415 (2011).
2. Macular translocation with 360° retinotomy for wet age-related macular degeneration. NICE interventional procedure guidance 340 (2010).
3. Limited macular translocation for wet age-related macular degeneration. NICE interventional procedure guidance 339 (2010).
4. Implantation of miniature lens systems for advanced age-related macular degeneration. NICE interventional procedure guidance 272 (2008).
5. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. NICE technology appraisal guidance 155 (2008).
6. Transpupilary thermotherapy for age-related macular degeneration. NICE interventional procedure guidance 58 (2004).
7. Radiotherapy for age-related macular degeneration. NICE interventional procedure guidance 49 (2004).
8. Guidance on the use of photodynamic therapy for age‑related macular degeneration. NICE technology appraisal guidance 168 (2003).

About NICE

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