UK agency proposes ban on Alzheimer’s drugs

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Britain’s agency charged with assessing whether drugs and procedures are worth their cost has issued a preliminary ruling against all of the four main drugs licensed for treating Alzheimer’s disease.

The National Institute for Clinical Excellence (NICE) said that Aricept, Exelon, Reminyl, and Ebixa should not be reimbursed by the national health service.

It advised that people taking the drugs “may be continued on therapy until it is considered appropriate to stop,” the institute said in preliminary recommendations.

Some 52,500 patients are taking the medicines in Britain. Although not a cure, clinical trials have shown that they can slow the progress of symptoms of the illness.

The recommendations follow an unfavourable review of the four drugs’ clinical effectiveness and cost effectiveness by NICE’s appraisals’ committee.

The committee said the clinical gains with the drugs called acetylcholinesterase inhibitors were small and the evidence on outcomes of importance to patients and caregivers, such as quality of life and time to institutionalisation, was “limited and largely inconclusive”.

It also concluded that the evidence for the clinical effectiveness of memantine, which is licensed for more severe Alzheimer’s disease, was “insufficient”.

The drugs cost between 828.30 pounds and 1160.96 pounds per patient per year and were “outside the range of cost effectiveness that might be considered appropriate for the NHS”.

The committee estimated that on present trends, NHS expenditure on Alzheimer’s drugs was set to rise from 48 million pounds in 2003-2004 to 60 million in 2004-2005 and upwards of 70 million in 2005-2006.

Though NICE’s advice does not yet constitute formal guidance and could change after consultation, it sent shockwaves through the pharmaceutical industry.

Eisai and Pfizer, which dominate the UK Alzheimer’s market, said in a statement they “condemned” the draft appraisal document, saying it was a “complete reversal” of previous NICE guidance issued in 2001.

Dr Paul Hooper, Managing Director of Eisai Ltd., said: “It is astounding that having substantially contributed to improving the plight of Alzheimer’s sufferers with their first guidance, NICE can seriously consider sending dementia treatment back ten years with this perverse appraisal document.”

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