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UK's NICE Recommends Novartis Pharmaceuticals UK Limited (NVS) Eye Drug Lucentis


8/27/2008 7:25:31 AM

FRIMLEY, England, August 27 /PRNewswire/ -- Novartis Pharmaceuticals UK Ltd (Novartis) today welcomed the Final National Institute for Health and Clinical Excellence (NICE) Technology Appraisal Guidance for age-related macular degeneration.

NICE guidance recommends Lucentis® (ranibizumab) for the treatment of patients with wet age-related macular degeneration (wet AMD). A key part of this guidance is the implementation of the Ranibizumab Reimbursement Scheme (RRS), a unique collaboration between Novartis, the Department of Health (DH) and NICE.

Novartis has already launched an interim version of the scheme, in an effort to provide immediate access for patients to ranibizumab on the NHS. However, final NICE guidance means that the final RRS can be rolled out nationwide. Following implementation, all suitable patients in England and Wales with wet AMD will have access to this clinically and cost-effective treatment.

The Ranibizumab Reimbursement Scheme provides patients in England and Wales with universal access to ranibizumab, where the first 14 injections in the eye to be treated will be paid for by the NHS and the drug cost of any subsequent ranibizumab injections will be reimbursed by Novartis.

Dr Rafiq Hasan, Director of Market Access and Ophthalmics, Novartis said: "We are delighted that NICE have confirmed Final Guidance for AMD. Wet AMD is a debilitating eye condition that can result in a rapid loss of sight if left untreated. Lucentis is a treatment for a key unmet medical need and it has the potential to save many peoples' sight."

He added: "The Ranibizumab Reimbursement Scheme is an innovative approach which shows how pharmaceutical companies can work together with NICE and the DH to ensure patients do get access to treatments on the NHS. Rapid implementation of the guidance is now needed to ensure that patients receive the treatment they need as soon as possible."

Mr Winfried Amoaku, Associate Professor of Ophthalmology and Hon Consultant Ophthalmologist (Retinal Specialist), University Hospital, Nottingham, and Vice-President of the Royal College of Ophthalmologists, commented: "We are extremely pleased that NICE has confirmed Final Guidance and hope that it is implemented without delay. The guidance, including the roll out of the Ranibizumab Reimbursement Scheme, will provide improved patient access to Lucentis."

Novartis is now working closely with retinal specialists, hospital pharmacists and commissioners to roll out the scheme and ensure suitable patients with wet AMD can start to get access to treatment as soon as possible.

About Lucentis®(ranibizumab)

Ranibizumab is licensed in the UK for the treatment of wet AMD(1), and has in clinical trials shown to be a potentially sight-saving treatment. Ranibizumab maintains vision in 9 out of 10 wet AMD patients(2),(3) and significantly improves vision in over 3 out of 10 patients(2),(3). This can help restore their independence so that they are better able to perform everyday activities, such as reading(4),(5).

Ranibizumab is an anti-VEGF (Vascular Endothelial Growth Factor) therapy, that neutralises all forms of VEGF-A(6). In wet AMD, VEGF-A is believed to cause abnormal blood vessel growth and leakage beneath the macular(6).

Anti-VEGF therapies bind to VEGF with the aim of blocking its effect to try and prevent more blood vessels from growing(7).

Results from clinical trials show that patients treated with repeated ranibizumab injections have a low rate (<1% of patients) of serious adverse events affecting the eyes and more than 90% of the patients remained on treatment for one year.(2),(3)

Ranibizumab has been developed by Genentech Inc and Novartis Pharmaceuticals UK Ltd has the marketing rights in the UK.

About Novartis

Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

(1) Lucentis (Ranibizumab) Summary of Product Characteristics. July 2007

(2) Brown et al. N Engl J Med 2006;355(14):1432-1444

(3) Rosenfeld PJ, Brown DM, Heier JS et al. Ranibizumab for Neovascular age-related macular degeneration. NEJM 2006;355; 1419-31

(4) Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD, for the National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol 2001; 119: 1050-1058

(5) Chang et al. Arch Opthalmol 2007; 125:1460 - 1469

(6) Ferrara N, Damico L, Shams N et al. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina 2006; 26: 859-870

(7) Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nature Medicine 2003; 9:669-676

Source: Novartis Pharmaceuticals UK Ltd


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