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UK Suggestion for Restricted Use of Anti-AMD Drugs Draws Flak

Campaigners have denounced as insensitive National Institute for Health and Clinical Excellence (Nice)s suggestion for restricted use of Lucentis (ranibizumab) and Macugen (pegaptanib) on the NHS . TWENTY thousand people will be condemned to blindness each year if the "cruel" and "appalling" decision is implemented, they contended.

Both Lucentis and Macugen are chief drugs used in combating all types of wet age-related macular degeneration (AMD), the leading cause of sight loss in the UK with 26,000 new cases each year.

Nice's preliminary guidance recommends Macugen should not be used at all on the NHS, while Lucentis should be restricted to about one in five patients.

It suggests the 20 per cent who are given the drug are those who have a particular type of wet AMD called predominantly classic subfoveal choroidal neovascularisation (CNV).

Nice also recommends Lucentis for use only when both eyes are affected, and only for use in the better-seeing eye.

It is stressed that such an approach effectively meant patients would be treated only once they had gone blind in one eye.

Wet AMD affects the central part of the retina called the macula and can lead to blindness in as little as three months.

The two drugs are known as anti-VEGF drugs and they work by targeting VEGF (Vascular endothelial growth factor), a protein that helps the formation of new blood vessels.

In the case of AMD these new blood vessels are unstable and tend to leak fluid and blood under the retina. The resulting scarring then causes irreversible sight loss. The anti-VEGF drugs inhibit the growth of new blood vessels, thereby minimising the risk of scarring.

Treatment with anti-VEGF drugs requires regular injections into the eye. In the case of Macugen six weekly injections are given. In the case of Lucentis the license provides for three four-weekly injections followed by a review every four weeks when the treating consultant decides about the need for further injections. In practice patients are likely to receive eight injections in the first year and six injections in the second year with further treatment depending on the progression of the disease.

The Royal National Institute of Blind People (RNIB) said it was "outraged" by Nice's ruling, which is still open to consultation. A final ruling on the drugs is expected in September.

RNIB's head of campaigns Steve Winyard said: "This preliminary guidance is worse than we ever imagined it could be.

"Anti-VEGF drugs have the potential to halve the number of people going blind each year and patients in the UK who can benefit from them must all have them - and quickly."

Tom Bremridge, chief executive of the Macular Disease Society, said: "We are appalled by the Nice consultation document - limiting the treatment options to 20 per cent of patients who would benefit is unjustifiable and allowing one eye to go blind before treating the second eye is cruel and totally unacceptable."

Nice is seeking to rationalize its decision on cost grounds. Andrew Dillon, chief executive of Nice, said: "When treatments are very expensive, we have to use them where they give most benefit to patients.

"Most people with AMD only seek help once the disease is beginning to affect their second eye.

"Because of this, and based on the evidence they have seen, our independent advisory committee believes the right thing to do is to treat and try to save as much sight as possible in the better-seeing eye."

A Nice spokeswoman also said it was "misleading" for anyone to suggest that patients have to go blind in one eye before getting treatment.

Patients in Scotland can already get both drugs, although there is concern that ruling will be overturned in light of Nice's decision. Former Labour MP Alice Mahon, who hers elf was denied Lucentis after being diagnosed with wet AMD last year, said the Nice guidance was "obscene".

Joanna Potts, business unit director of ophthalmology for Novartis, which markets Lucentis in the UK, said: "The clinical and health economic data supports the use of Lucentis in all types of wet AMD and for both the first and second eye affected, yet Nice appear to have ignored this robust body of evidence."

Macugen is manufactured by Pfizer. The company's medical director David Gillen said: "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 licence to reflect this."

A spokeswoman for the Department of Health said Primary Care Trusts should not withhold funding for the drugs in light of the draft guidance.

She added: "This is not final guidance to the NHS from Nice but draft recommendations that have been issued for consultation which the Department of Health will be responding to.

"Macugen and Lucentis are licensed drugs and we have made it clear to PCTs that they should not withhold funding for treatments because Nice guidance is not available."

But shadow health minister John Baron said: "This decision is very odd given that Gordon Brown's constituents are going to get Macugen and Lucentis on the NHS, but patients in England are not."


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