NICE gives green light to treatment for wet AMD in final draft guidance
30 May 2013
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending aflibercept solution for injection as an option for treating wet age-related macular degeneration (AMD).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, but does not lead to total loss of sight and is not painful. 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.
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 155i (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.
People currently receiving aflibercept solution for injection whose disease does not meet the criteria above should be able to continue treatment until they and their clinician consider it appropriate to stop.
The independent Committee decided that an appraisal consultation document (ACD) was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licensed indication.
Sir Andrew Dillon, NICE Chief Executive said: "Wet AMD can have a significant effect on day-to-day life for people with the disease, so NICE is pleased to recommend aflibercept solution as a treatment option in final draft guidance. The independent Committee concluded that the recommendations can go straight to a final draft, without the need for public consultation, which will help speed up access to this treatment."
The final draft guidance (final appraisal determination / FAD) can be found from 00:01hrs Friday 31 May on the NICE website.
NICE has not yet issued final guidance to the NHS; these decisions may change in the event of an appeal. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
Final guidance is expected to be published in August 2013.
Notes to editors
References and explanation of terms
i. Ranibizumab is recommended as a possible treatment for people with wet AMD if all the following apply to their eye:
- The best possible visual acuityii after correction with glasses or contact lenses is between 6/12 and 6/96.
- There is no permanent damage to the foveaiii (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 the guidance pages on the NICE website.
ii. The best-corrected visual acuity refers to the best possible vision a person can achieve with corrective contact lenses or glasses.
iii. 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 can be found from 00:01hrs BST on Friday 31 May 2013 on the NICE website.
Embargoed copies are available on request; please contact the press office.
2. 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)'.
3. The summary of product characteristics states that treatment should be given monthly for 3 consecutive 2 mg doses, followed by 1 injection every 2 months, with each 100 microlitre vial containing 4 mg of aflibercept. Aflibercept solution for injection must only be administered by a qualified doctor experienced in administering intravitreal injections. 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.
4. 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).
5. 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.
6. 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.
7. NICE technology appraisals apply across the NHS in England and Wales.
8. 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.
9. For further details on NICE technology appraisals, please see the NICE website.
Related NICE guidance
10. Epiretinal brachytherapy for wet age related macular degeneration. NICE interventional procedure guidance 415 (2011).
11. Macular translocation with 360° retinotomy for wet age-related macular degeneration. NICE interventional procedure guidance 340 (2010).
12. Limited macular translocation for wet age-related macular degeneration. NICE interventional procedure guidance 339 (2010).
13. Implantation of miniature lens systems for advanced age-related macular degeneration. NICE interventional procedure guidance 272 (2008).
14. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. NICE technology appraisal guidance 155 (2008).
15. Transpupilary thermotherapy for age-related macular degeneration. NICE interventional procedure guidance 58 (2004).
16. Radiotherapy for age-related macular degeneration. NICE interventional procedure guidance 49 (2004).
17. Guidance on the use of photodynamic therapy for age-related macular degeneration. NICE technology appraisal guidance 168 (2003).
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