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.

About the guidance

  • The guidance is available on the NICE website.
  • 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.
  • 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)'.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • NICE technology appraisals apply across the NHS in England and Wales.
  • 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.
  • Further details on NICE technology appraisals.

Statement from RNIB

Steve Winyard, RNIB's Head of Campaigns, said: "We welcome the news NICE has approved the use of a further drug to treat the biggest cause of sight loss in the UK.

"Not only does it mean patients now have the choice of two different drugs to treat their condition, it also means if they choose the newly approved drug it could mean less visits to the hospital.

"Some people with wet AMD do not respond to the current NICE approved treatment and another option could mean the difference between saving and losing their sight.

"We've recently launched a national campaign encouraging over 50s to spot the signs of wet AMD, which affects about 40,000 people each year and can destroy a person's sight in as little as three months.

"Losing your central vision can have profound consequences with many people unable to carry out basic tasks such as driving, chopping vegetables, or writing a shopping list. However, it doesn't have to be this way and people should not be losing their sight unnecessarily when there's treatment available."