Letter from Dr Paul Beaumont, Chairman, Medical Committee & Professor Paul Mitchell, National Research Advisor:
MD Foundation (Australia)

download this letter
download the reference
back to sample letters

11 July 2007
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London
WC1V 6NA

Dear Sir

RE: Decision by NICE regarding the provision of anti–VEGF treatments in England and Wales

The Macular Degeneration (MD) Foundation is the peak national body working on behalf of the MD community to reduce the incidence and impact of MD in Australia.

The Foundation strongly appeals that the recommendation made by NICE relating to treatment of Wet AMD be reconsidered.

An Access Economics Report released last year revealed that AMD costs Australians $2.6 billion a year. In Australia, after careful consideration of the economic impact alone, the Government approved Lucentis for all lesion types of subfoveal neovascular AMD.

We are greatly concerned that the National Institute for Health and Clinical Excellence, (NICE) issued stringent preliminary guidance that will deny Lucentis to 80 percent of patients with wet AMD in England and Wales. Lucentis is the only anti–VEGF agent proven in randomized clinical trials to be both safe and effective in preventing blindness in Wet AMD.

The NICE proposed criteria of having to go blind in one eye before being offered treatment for the second eye almost defies belief because many elderly patients present late with reduced visual acuity even in the second eye and are thus at significant risk of bilateral blindness despite the availability of anti–VEGF therapy for the second eye. This decision needs urgent review as over 20,000 people a year will be denied access to these ground breaking anti–VEGF treatments and will suffer from degenerating eyesight and potential blindness. The consequences of significant vision loss on individuals and the community is profound and far reaching both socially and economically. The main impact of this loss is on the quality of life of the individual and their immediate family and on their community inclusion. It also results in extensive community dependence and the need for support.

It is well known from treating patients presenting with Wet AMD in their first eye that the suffering for the patient goes beyond the loss of vision in that eye and extends into the fear and anxiety of an equivalent loss of vision in the remaining eye.

The Foundation draws NICE’s attention to the sub analysis of the trial data which showed the loss of quality of life with loss of vision in the untreated worse eye, which in most instances were cases with first eye involvement. It was prevented by Lucentis treatment in both trials.

This together with the Blue Mountains Eye Study data indicating that even unilateral visual impairment, when moderate or severe, has a substantial impact on health related quality of life (see attached reference) leave us in no doubt of the tragic consequences of not treating the eye that first loses vision from this disease. It is sad that many people may have to suffer unnecessarily.

A second anomaly in the decision made by NICE was the failure to approve safe and effective treatment for types of neovascular lesion, other than those categorized as ‘predominantly classic’, when the efficacy of Lucentis was shown to be independent of the type of lesion.

In Australia, this treatment was approved for subsidy by the Pharmaceutical Benefits Scheme solely on the basis of economics (cost effectiveness). Even before the consideration of quality of life issues, the case for funding was deemed convincing, reasonable and justifiable.

The argument for the provision of such treatments is the same no matter where you live in the world.

The economic, emotional and social cost to the individual, the community and to the country begs the question can NICE afford not to act and review this decision?

If the decision is not reviewed, it is likely that in the near future the people of England and Wales will demand the decision makers answer one simple question – Why?

Why was the first treatment proven in large controlled clinical trials to not only preserve but improve vision denied to so many? Why do the level of fractures, falls, depression and nursing home admissions have to increase for thousands of people as a result of severe vision loss when such an effective treatment was available? How could risking going blind in one eye be considered a rational argument for the use of a treatment?

Why should the people of England and Wales be denied what is readily available in Scotland, Australia and Switzerland?

Finally, these countries are all first world economies who can afford the equivalent costs. Why should where you live in the world determine the safety and efficacy of treatment available to you? Simply answered – it should not.

Yours sincerely,

Dr Paul Beaumont
Chairman, Medical Committee
MD Foundation (Australia)

Professor Paul Mitchell
National Research Advisor
MD Foundation (Australia)

download this letter
download the reference
back to sample letters