NICE Recommends Lucentis® (Ranibizumab) For Some Patients With Visual Impairment Due To Diabetic Macular Oedema (VI-DMO) In Draft Guidance
The National Institute for Health and Clinical Excellence (NICE) has today issued positive draft guidance on the use of ranibizumab for the treatment of VI-DMO, an eye condition which can occur in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness,,. 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 vision loss and sustain visual improvement.
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,,,.
Novartis 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. Novartis 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.
Visual impairment can cause significant reductions in quality of life, limiting daily activities including working, driving, managing medications and social interactions,. 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.
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%).
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 macular oedema secondary to Retinal Vein Occlusion (RVO) (central and branch), visual impairment due to Diabetic Macular Oedema (DMO) and wet Age Related Macular Degeneration (AMD). Lucentis 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,.
 National Institute for Health and Clinical Excellence- Draft guidance on the use of ranibizumab for the treatment of VI-DMO
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