Alzheimer's drugs appeal refused

Alzheimer's disease groups have condemned a decision by the NHS drugs watchdog to reject their appeal for greater access to certain drugs.

The National Institute for Health and Clinical Excellence said donepezil, rivastigmine and galantamine could be used to treat moderate stage disease.

Campaigners had argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.

But NICE said studies showed the drugs "did not make enough of a difference."

This blatant cost-cutting will rob people of priceless time

Neil Hunt, Alzheimer's Society

Drug 'improved our lives'

It has also ruled another drug, memantine, should only be used in clinical studies for people with moderately severe to severe Alzheimer's disease.

Eisai and Pfizer, who produce donepezil (Aricept) said they were "evaluating their options with respect to judicial review by the High Court" following NICE's decision.

Around 750,000 people in the UK are estimated to have dementia. But only 78,000 patients take donepezil, rivastigmine and galantamine, with two thirds of those taking donepezil.

Restrictions

NICE guidance in 2001 recommended the drugs, which can make it easier to carry out everyday tasks, should be used as standard.

Galantamine is also known as Reminyl, rivastigmine as Exelon and memantine as Ebixa.

But in July 2005, NICE said access to the drugs should be restricted because they were not good value for money.

It has now issued its final guidance.

Andrew Dillon, chief executive of NICE, said: "Alzheimer's is a cruel and devastating illness and we realise that today's announcement will be disappointing to people with Alzheimer's and those who treat and care for them.

"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 disease.

"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."

'Fundamental flaws'

Action on Alzheimer's, an alliance of more than 30 professional and patient organisations, reacted angrily to NICE's ruling.

"The decision will force patients to wait until their condition deteriorates into a state of fear and confusion before receiving drugs that work.

"There is evidence that these drugs work at all stages of the disease, but NICE proposes to restrict their use on grounds of cost."

Neil Hunt, chief executive of the Alzheimer's Society, 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."

He said there had been "fundamental flaws" in NICE's appraisal process, and called on the government to step in.

Help the Aged said one in five people over 80 were affected by dementia and the number of people living with the disease was set to double in a decade.

Jonathan Ellis, senior policy manager at the charity, added: "It cannot be right to allow the health of thousands of older people to deteriorate on the altar of cost.

"On the one hand, the government says it is committed to improving care for older people, while on the other NICE is blocking access to treatment which would help them retain their independence and dignity. This is botched policy making at its worst."

But a Department of Health spokesman said it would be "entirely inappropriate" to over-rule NICE's decision.

'Questions needed'

Dr Anthony Pelosi, a consultant psychiatrist at Hairmyres Hospital, East Kilbride, said adequate research had not been carried out into the effects of the drugs.

"We still do not know, about 10 years after they became available, whether these medications are effective enough to justify their use in Alzheimer's disease at mild, moderate and severe stages.

"Do they improve most patients' overall quality of life? What about their effects on quality of life of the relatives? Do the tablets slow down the time until nursing home care is required?

"We do not really know the answers to these questions."

NICE guidelines cover England and Wales, but the health bodies in Scotland often follow suit.

This final guidance will only apply to newly diagnosed patients.

Those already taking the drugs will continue to do so.