More than 20,000 people a year with Wet AMD face blindness as NICE announces provisional recommendation
14 June 2007
Today NICE releases its Appraisal Consultation Document (ACD) for the use of licensed anti–VEGF medicines in patients with wet age-related macular degeneration (AMD). The preliminary recommendation states that pegaptanib (Macugen®), a selective-VEGF inhibitor, is not recommended for the treatment of wet-AMD. In addition, ranibizumab, a non selective VEGF inhibitor, is only recommended for a minority of people with a specific type of wet AMD (predominantly classic subfoveal choroidal neovascularisation), in their second eye.
The introduction of Macugen in February 2006 represented a significant innovation by maintaining vision in patients with all types of wet AMD. Furthermore, evidence and clinical experience with Macugen suggests that treating patients with early disease may result in superior visual outcomes.[i]
Dr David Gillen, Medical Director, Pfizer comments ‘Pfizer is very disappointed with this preliminary decision. Macugen has been shown to maintain vision in patients with all types of wet AMD and has a license to reflect this. From a cost perspective, it has been convincingly demonstrated that Macugen’s cost-effectiveness can be enhanced when treatment is started at an early stage before too much vision is lost (vision between 6/12 and 6/24). The NICE economic model did not appropriately address this important issue and therefore underestimated the cost-effectiveness of Macugen. We will be discussing this further with NICE, in conjunction with relevant parties, to help patients gain access to this innovative treatment’.
There are approximately 26,000 new cases of wet AMD in the UK each year1 and AMD is the leading cause of sight-loss for people over the age of 50 in the Western world.[ii] Based on NICE’s provisional recommendation, 80% (i.e. over 20,0001) of these patients will be left to go blind, with the 20% who are eligible for treatment having gone blind in their first eye.
Steve Winyard, Head of Campaigns at the Royal National Institute of the Blind (RNIB) comments on the decision ‘The RNIB is outraged by the preliminary guidance. It ignores the overwhelming body of evidence that these new treatments are cost-effective and have the potential to halve the number of people going blind each year. It is simply unacceptable that only a small minority of patients within England and Wales will have access to these ground-breaking drugs. NICE must re-consider and show that it makes its decisions based on cost-effectiveness rather than simply cost containment.’
Tom Bremridge, Chief Executive, Macular Disease Society continues ‘We are truly surprised by this announcement – to limit the treatment options in the first place is outrageous, and to endorse the second-eye policy is unbelievable. Along with the RNIB, we will be submitting a response to NICE to encourage a re-analysis’.
The direct and indirect costs of blindness to the UK are significant, with an estimated cost of over five billion pounds per year.[iii] From an individual’s perspective, going blind affects more than just their physical health – sight loss has a significant impact on mental and emotional wellbeing too.[iv] Estimations of cost-effectiveness are inherently uncertain and typically a range of values are considered. NICE investigated 28 scenarios, 25 of these showed pegaptanib to be cost-effective using the Pfizer model. NICE selectively decided to adopt a worse case scenario whereby no treatment was deemed cost-effective. This scenario assumed treatments would be administered as a more costly day case procedure. This is not consistent with current practice or widespread clinical opinion as reflected in the Royal College of Ophthalmologists AMD services guideline.[v]
Winfried Amoaku, Consultant Ophthalmologist, Queen’s Medical Centre, Nottingham University Hospitals NHS Trust, says ‘Both anti-VEGF treatments should be made available to ophthalmologists – one treatment doesn’t fit all and ophthalmologists should be able to prescribe the most suitable option for their patient. We are dealing with a patient population who are likely to have co-morbidities, and be on several other medicines – the most appropriate and effective treatment will be specific to that particular patient.’
Pegaptanib was the first anti-VEGF medicine approved for the treatment of wet AMD in February 2006. It is designed to selectively target the VEGF isoform preferentially involved in the pathological ocular neovascularisation and can be used to treat all sub-types of wet AMD.[vi] The rate of systemic adverse events such as hypertension, thromboembolic events and haemorrhagic events occurred at a rate similar to the control group after two years.[vii] Clinical trials have shown that after three years of treatment with pegaptanib, the systemic safety profile was sustained, with no new or additional systemic safety signals observed.[viii]
As the world’s leading pharmaceutical company, Pfizer is committed to improving the lives of patients and will continue to work with the RNIB and Macular Disease Society to help patients with wet-AMD receive the best possible care.
The full NICE ACD document is available at:
www.nice.org.uk
For further information please contact:
Anthea Morris / Claire Eldred
Edelman
Tel: 0207 344 1279 / 0207 344 1342
Email: anthea.morris@edelman.com / claire.eldred@edelman.com
Press Office
Pfizer Ltd
Tel: 01737 332 332
Fax: 01737 332 527
E-mail: pressofficepgp-uk@pfizer.com
Notes to Editors:
Notes to Editors: The Scottish Medicines Consortium approved the use of Macugen within Scotland for patients with wet age-related macular degeneration in August 2006.
References [i] Gonzales CR. The VEGF inhibition study in ocular neovascularisation (VISION) clinical trial group. Enhanced efficacy associated with early treatment of neovascular age-related macular degeneration with pegaptanib sodium: an exploratory analysis. RETINA 2005; 25: 815-827.
[ii] AMD Alliance [Online]. Homepage – Age Related Macular Degeneration (cited 12 June 2007). Available from http://www.amdalliance.org/
[iii] Winyard S. The cost of sight loss in the UK. RNIB campaign report; 23 August 2004. Cited in McLaughlan B, Winyard S. AMD Alliance UK Report: Left to pay their own way: how people facing sight loss from wet age-related macular degeneration are let down by the NHS; October 2006.
[iv] Cruess A, Xu X, Mones J, Lotery A, Pauleikhoff A, Soubrane G, Zlateva G, Goss T. Humanistic Burden and Health Resource Utilization Among Neovascular Age-Related Macular Degeneration Patients: Results from a Multi-Country Cross-Sectional Study. Presented at ARVO 2006 April 30-4 May 2006, Fort Lauderdale, Florida.
[v] The Royal Colege of Ophthalmologists, Commissioning Contemporary AMD Services: a guide for commissioners and clinicians, June 2007.
[vi] Macugen Summary of Product Characteristics
[vii] VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group. Pegaptanib Sodium for Neovascular Age-Related Macular Degeneration: Two Year Safety Results of the Two Prospective, Multicenter, Controlled Clinical Trials. Ophthalmology. June 2006; Volume 113; Issue 6; Pages 992-1001
[viii] Suner IJ. Safety of Pegaptanib Sodium in Age-Related Macular Degeneration (AMD): 3-Year Results of the V.I.S.I.O.N Trial. Poster presented at American Association of Ophthalmology; October 2006.
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