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Published on 9 May 2014

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SMC accepts EYLEA® for another potentially serious eye condition

The Scottish Medicines Consortium (SMC) announced that Eylea® (aflibercept solution for injection) has been accepted for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO).(1)

CRVO is a serious condition affecting the main vein in the eye(2) that, if left untreated, can cause blindness and other painful eye conditions.(3)

The Scottish Medicines Consortium (SMC) announced that Eylea® (aflibercept solution for injection) has been accepted for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO).(1)

CRVO is a serious condition affecting the main vein in the eye(2) that, if left untreated, can cause blindness and other painful eye conditions.(3)

This decision means that eligible patients in Scotland with this challenging eye condition will now have access to a new medication that improves vision from the start of treatment(4,5) without the need to visit the hospital every month for monitoring or treatment once the condition has stabilised.(6)

Dr Mike Gavin, Consultant Ophthalmologist, Gartnavel General Hospital, Glasgow, Scotland, commented, “This decision will be welcomed by ophthalmologists across Scotland as having Eylea, an established and proven treatment, also available for this unpredictable and difficult to treat condition, macular oedema following CRVO, will improve clinician choice, helping us to find the right treatment for the right patient.”

Macular oedema, or fluid beneath the macula (a tiny part of the retina at the back of the eye), is one of the complications of CRVO that occurs when there is a blockage in the main vein that carries blood away from the eye.(2) It is estimated that almost 6,000 people, aged 45 and over, have macular oedema secondary to CRVO in Scotland.(7–9) The impact of the associated vision loss can have a profound effect on vision-related quality of life. Patients may struggle with daily tasks, lose confidence and become increasingly dependent.(10)

Like current treatments for visual impairment due to macular oedema secondary to CRVO, Eylea is given as an injection into the eye by a trained ophthalmologist. After the initial injection, treatment is given monthly. Monthly treatment continues until visual and anatomic outcomes are stable for three monthly assessments. Thereafter, the need for continued treatment should be reconsidered. If necessary, treatment may be continued with gradually increasing treatment intervals to maintain a stable visual and anatomic outcome.(6)

John Legg, Director of sight loss charity RNIB Scotland, said: “We welcome any move that extends effective treatment options for people who suffer from macular oedema secondary to central retinal vein occlusion (CRVO), one of the main threats to vision among our ageing population. We need to take steps now to contain, as far as possible, a potentially significant increase in the number of people with sight loss by treating patients early on before impairment gets worse.”

Eylea was licensed in the UK for the treatment of visual impairment due to macular oedema secondary to CRVO in August 2013(6) and the National Institute for Care and Excellence (NICE) recommended Eylea for this indication in February this year for use in England and Wales.(11)

Eylea has been licensed in the UK for the treatment of wet age-related macular degeneration (wAMD) since November 2012.(6) Eylea was accepted by the SMC for use within NHS Scotland for the treatment of wAMD in April 2013.(12) It was also recommended by NICE for this use on the NHS in England and Wales in July 2013 and availability to eligible wAMD patients is now mandated across England and Wales.(13)

References

1.     Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®). April 2014. Available at: http://www.scottishmedicines.org.uk (accessed 9 May 2014).

2.     Royal National Institute of Blind People. Retinal Vessel Occlusion. Available at: http://www.rnib.org.uk/eyehealth/eyeconditions/eyeconditionsoz/Pages/retinal_vessel_occlusion.aspx (accessed March 2014).

3.     Lazric R et al. Anti-VEGF in Treatment of Central Retinal Vein Occlusion. Coll Antropol 2010;34:69–72.

4.     Brown DM et al. Intravitreal aflibercept injection for Macular Edema secondary to Central Retinal Vein Occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol 2013;155:429–37.

5.     Holz FG et al. Intravitreal aflibercept injection for Macular Edema resulting from Central Retinal Vein Occlusion: one-year results of the phase 3 GALLILEO study, Br J Ophthalmol 2013;97:278–84.

6.     Eylea® (VEGF Trap-Eye) summary of product characteristics (SmPC).

7.     Scottish Census 2011.

8.     National Institute for Health and Care Excellence. TA305 Macular oedema (central retinal vein occlusion) – aflibercept solution for injection: costing template. Available at: http://guidance.nice.org.uk/TA305/CostingTemplate/xls/English (accessed March 2014).

9.     The Central Vein Occlusion Study Group. Baseline and early natural history report, the Central Vein Occlusion Study. Arch Ophthalmol1993;111:1087–95.

10.  National Institute for Health and Care Excellence. Proposed Health Technology Appraisal, Aflibercept solution for injection for the treatment of macular oedema caused by central retinal vein occlusion. Available at: http://www.nice.org.uk/nicemedia/live/14071/63448/63448.pdf(accessed July 2013).

11.  National Institute for Health and Care Excellence. Final Appraisal Determination. Aflibercept for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion. February 2014.

12.  Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®) SMC No. (857/13). Available at: http://www.scottishmedicines.org.uk (accessed March 2014).

13.  National Institute for Health and Care Excellence. Technology Appraisal 294. Aflibercept solution for injection for treating wet age related macular degeneration. July 2013.

14.  Morley MG, Heier JS. Venous obstructive disease of the retina. In: Yanoff M, Duker JS, et al., editors. Ophthalmology. 3rd ed. [Edinburgh]: Mosby Elsevier; 2009.

15. Rehak J, Rehak M. Branch retinal vein occlusion: pathogenesis, visual prognosis, and treatment modalities. Curr Eye Res2008;33:111–31.

16.  The Royal College of Ophthalmologists. Interim guidelines for management of retinal vein occlusion. 2009. Available at: http://www.rcophth.ac.uk. (accessed March 2013).



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