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NICE Recommends Lucentis® (Ranibizumab) For Some Patients With Visual Impairment Due To Diabetic Macular Oedema (VI-DMO) In Draft Guidance

The (NICE) has today issued positive draft guidance on the use of ranibizumab for the treatment of VI-DMO, an eye condition which can occur in people with diabetes that causes blurred vision, severe and sometimes blindness[1],[2],[3]. This means that some patients (those with a retinal thickness of 400 micrometres or more), could soon benefit from a treatment which can potentially restore vision, prevent and sustain visual improvement[4].

Ranibizumab is the only licensed anti-vascular endothelial growth factor (VEGF) treatment for VI-DMO, a condition for which the standard of care has not changed significantly in 25 years. In the UK, the current standard of care for patients with VI-DMO is laser treatment. Laser treatment slows the rate of vision loss and helps stabilise vision but is not suitable for all patients, due to the nature of their condition. Unlike ranibizumab, laser treatment is not generally associated with improvements in vision4,[5],[6],[7].

is pleased that NICE has recognised that ranibizumab has a role to play in the management of VI-DMO and considers its decision an important step forward in improving the standard of care for patients with the condition. however remains concerned that limiting ranibizumab to those with a retinal thickness of 400 micrometres or more will result in patients with high unmet need, who do not meet the criteria, not gaining access.

can cause significant reductions in quality of life, limiting daily activities including working, driving, managing medications and social interactions[8],[9]. Caught in the early stages of the disease, a 10 letter gain in vision on a sight chart could make the difference between being able to drive and not drive[10].

In clinical trials, ranibizumab has been shown to double the likelihood of gaining >10 letters of vision, compared to laser (37.4% vs. 15.5%, respectively) and reduce the chance of losing >10 letters of vision by up to three-fold compared to laser (3.5% vs. 12.7%, respectively)4. Results of a recent study suggest that the long term outcomes achieved with laser therapy in real life clinical practice are even poorer than those demonstrated in clinical trials, with three times more patients losing vision (>15 letter loss) in the real life setting compared with clinical trial results (27% vs. 8%)[11].

There is now a three week consultation period of the Appraisal Consultation Document (ACD), with the final draft guidance, the Final Appraisal Document (FAD), expected by the end of 2012 or in early 2013. Novartis remains committed to ensuring that as many patients as possible with VI-DMO have access to ranibizumab and will remain in discussions with NICE to make this possible.

About Lucentis® (ranibizumab)

Ranibizumab is an anti-vascular endothelial growth factor (anti-VEGF) licensed for the treatment of visual impairment due to secondary to Retinal Vein Occlusion (RVO) (central and branch), visual impairment due to Diabetic (DMO) and wet Age Related Macular Degeneration (AMD). is approved by the National Institute for Health and Clinical Excellence (NICE) for the treatment of wet AMD and by the Scottish Medicines Consortium (SMC) for wet AMD and the treatment of visual impairment due to macular oedema secondary to Central-Retinal Vein Occlusion (CRVO). Ranibizumab was developed by Genentech and Novartis. Genentech has the commercial rights in the US, while Novartis has exclusive rights in the rest of the world.

About visual impairment due to diabetic macular oedema

Diabetic macular oedema (DMO) is an ophthalmic complication of diabetes. It is a type of diabetic retinopathy that can cause visual impairment. DMO is caused by the leaking of fluid from the small blood vessels in the eye. The build-up of fluid causes swelling and thickening at the macula (the centre of the eye), reducing vision. The early stages of DMO are often asymptomatic however later blurred vision may occur. If left untreated, permanent damage or even blindness may occur. Visual impairment due to DMO occurs more commonly when a person’s diabetes has been poorly controlled. All people with diabetes are at risk of developing visual impairment due to DMO but only a small proportion (approximately 1-3%) will develop it, which equates to 50,000 people in the UK living with the condition. In the UK, we estimate that around 5,000 new patients will be affected by the condition each year[12],[13].

Source

[1] National Institute for Health and Clinical Excellence- Draft guidance on the use of ranibizumab for the treatment of VI-DMO

[2] Davidov E et al. Diabetic retinopathy and health-related quality of life. Graefes Arch Clin Exp Ophthalmol 2009;247:267–272

[3] International Diabetes Federation. Fact sheet Diabetes and eye disease. Available at: http://www.idf.org/fact-sheets/diabetes-eye-disease Last accessed October 2012

[4] Mitchell P et al. The RESTORE Study. Ophthalmology 2011; 118:615-625

[5] Lucentis SPC – Available at: http://www.medicines.org.uk/emc/medicine/19409/SPC/Lucentis+10+mg+ml+solution+for+injection Last updated 30th August 2012

[6] Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 1985 Dec;103(12):1796-806.

[7] The Royal College of Ophthalmologists. Guidelines for Diabetic Retinopathy 2005.

[8] Cuilla TA et al. Diabetic Retinopathy and Diabetic Macular Edema. Diabetes Care 2003; 26:2653–2664

[9] Hariprasad SM et al. Vision-related quality of life in patients with diabetic macular oedema. Br J Ophthalmol 2008;92:89–92

[10] Mangione CM et al. Development of the 25-Item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol 2001;119:1050-1058

[11] Jyothi S and Sivaprasad S. Continuing medical education: five-year visual outcome following laser photocoagulation of diabetic macular oedema. Eye 2011; 25,850-859

[12] Diabetes UK. Diabetes in the UK 2010: Key statistics on diabetes. 2010

[13] Minassian DC, Owens DR, Reidy A. Modelling the prevalence of age-related macular degeneration (2010-2020) in the UK: expected impact of anti-vascular endothelial growth factor (VEGF) therapy. Br J Ophthalmol. 2011 Oct;95(10):1433-6. Epub 2011 Feb 12.

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