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Alzheimer's drug ruling ''a terrible decision''

Published on 11/10/06 at 05:10pm

Campaigners are stunned at NICE's final decision not to allow Alzheimer's drugs to be prescribed on the NHS in the early and late stages of the disease.

NICE has announced that Eisai/Pfizer's Aricept, Novartis' Exelon and Shire's Reminyl should only be considered as options in the treatment of people with moderate Alzheimer's disease.  

Lundbeck's Ebixa will be barred from use on the NHS altogether, with NICE only recommending its use as part of clinical studies for people with the moderately severe to severe disease.

The announcement could be the final defeat for campaigners in their long-running battle against NICE since it first announced the decision in March 2005.

Last-ditch appeals by an alliance of campaigners were made against the ruling this summer, but an appeal committee has backed the NICE appraisal committee's decision.

A NICE review in 2001 had backed the drugs, but new evidence persuaded NICE that the drugs were not sufficiently cost or clinically effective in most cases.

Andrew Dillon, NICE chief executive, said the organisation "had to be honest" and recognise the evidence did not show enough benefit to patients to warrant their recommendation.

"Alzheimer's is a cruel and devastating illness and we realise that our announcement will be disappointing to people with the disease and to those who treat and care for them," said Dillon.

"But we have to be honest and say that based on all the evidence, including data presented by the drug companies themselves, our experts have concluded that these drugs do not make enough of a difference for us to recommend their use for treating all stages of Alzheimer's.  

"We have recommended the use of these drugs where they have the potential to make a real difference  which is at the moderate stage of the illness."

Drug companies and the dementia campaigners have reacted in anger and dismay at NICE's decision.

Eisai and Pfizer said they are evaluating their options, and may still mount a legal challenge in the High Court. A spokesman for the companies said they would be considering both the fairness and the transparency of this specific appraisal as well as the fairness of the NICE appeals procedure.

Pfizer's managing director Dr Oliver Brandicourt, commented: "NICE has ignored the evidence of patients, charities, researchers and doctors that these drugs are of benefit in the mild as well as moderate stages of the illness. Alone in the world, patients in England and Wales will lose the chance to fight Alzheimer's disease at an early stage."

The Alzheimer's Society also hit out at the decision.  Neil Hunt, the charity's chief executive, said: "What sort of society have we become when the health of hundreds of thousands are sold to save just £2.50 a day?"

He added: "This blatant cost-cutting will rob people of priceless time early in the disease and later clinicians will have no choice but to use dangerous sedatives that increase the risk of heart disease and stroke. This is victimisation of the most vulnerable in society."

Around 750,000 people in the UK have dementia, but only 78,000 patients take Aricept (donepezil) Exelon (rivastigmine) and Reminyl (galantamine) with two thirds of those taking Aricept.

Many doctors in the field had pledged to disobey NICE's ruling, even before this final judgement was announced, but are likely to face removal of funding for the treatments in their NHS trusts.

Patients already taking the medicines will be allowed to stay on them, but new patients will have to follow the new stricter guidelines.

Dr David Anderson, chair faculty of old age psychiatry at the Royal College of Psychiatry, said: "This is a terrible decision based on a deeply flawed process. I am astonished that the appeals against this guidance have been disregarded.

He declared: "Implementation of this guidance will set the treatment of Alzheimer's disease back 10 years, while the number of sufferers continues to increase rapidly. It is extremely short-sighted to deny these people access to effective treatment."

NICE is delaying the final, official release of its guidance on Alzheimer's to await the completion of clinical guidelines on the management of all types of dementia, including Alzheimer's.

The guidelines are being drawn up jointly with the government's Social Care Institute for Excellence. NICE's Andrew Dillon said: "It is in the interests of patients and those who care for them that both pieced of advice are published at the same time.

The publication date for the appraisal and the dementia guideline is Wednesday, 22 November 2006.


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