Oct 16 2006
It appears that people in Britain suffering from Alzheimer's disease will be unlikely to benefit from the use of four drugs designed to treat the the degenerative brain disease.
The UK watchdog the National Institute for Health and Clinical Excellence (NICE) has rejected appeals from patient groups and drug makers, and says that on the basis of all the evidence, they will not recommend their use for treating all stages of Alzheimer's disease.
NICE Chief Executive Andrew Dillon says they realise the news will be a disappointment to people with Alzheimer's and those who treat and care for them, but despite the data presented by the drug companies, their experts have reached the conclusion that the drugs do not make enough of a difference for them to to be recommended for use in treating all stages of Alzheimer's disease.
NICE says the anti-cholinesterase drugs, which can help but not cure some Alzheimer's patients, should be prescribed only for a minority of people with the degenerative brain disease.
The news is certain to re-ignite the controversy over the rationing of treatments on Britain's National Health Service but the position is in fact a partial climb-down as NICE originally suggested the drugs were not worth the money for any patients.
The new guidance means that the drugs Aricept (donepezil), Exelon (rivastigmine) and Reminyl (galantamine) will only be prescribed for patients with Alzheimer's disease of moderate severity.
Critics say the move deprives the majority of early-stage Alzheimer's disease sufferers of a treatment option that is widely available in other countries.
Ebixa (memantine) is given to patients with more serious disease, but NICE is not convinced of its benefits and says it should only be used in clinical trials.
Drug companies Eisai and Pfizer, who produce Aricept, are considering whether to seek a judicial review of the decision.
Charities caring for Alzheimer's patients and some medical experts have condemned NICE's decision and the Royal College of Psychiatrists says the news is a terrible decision based on a deeply flawed process, which will set the treatment of Alzheimer's disease back 10 years.
Others accept the decision and agree that the drugs are of uncertain value and have a very small effect in patients with dementia.
It is estimated that 750,000 people in the UK have dementia, but only 78,000 patients take donepezil, rivastigmine and galantamine, and two thirds of those take donepezil.
In 2001 NICE recommended the drugs - which can make it easier to carry out everyday tasks - should be used as standard, however, in July 2005 it said access to the drugs should be restricted because they were not good value for money.
It has now issued its final guidance, which will apply only to newly-diagnosed patients; those already taking the drugs will continue to do so.
Action on Alzheimer's, an alliance of more than 30 professional and patient organisations, says the decision will force patients to wait until their condition deteriorates into a state of fear and confusion before receiving drugs that work.
The drugs cost around 1,000 pounds ($1,860) per patient a year.