Concern over decision that new Alzheimer drugs only available for advanced disease

Jan 24 2006

The recommendation by the National Institute of Clinical Evidence (NICE), that Alzheimer's drugs should be used in a minority of people with the degenerative brain disease, has created both rage and disbelief from charities and drug companies alike.

The cost-effectiveness watchdog's decision is seen by many as a partial climbdown as last year they suggested that anti-cholinesterase drugs were not worth the outlay for any patients.

The new draft guidlines, are subject to further consultation, and say that patients should only be allowed the drugs after the disease had advanced.

According to the Alzheimer’s Society, that is precisly when patients become unable to care for themselves, and have branded the the decision unethical and lacking clinical sense.

Clive Ballard, the director of research for the charity says it puts doctors in an impossible position as patients have to get worse before they can be prescribed drugs designed to stop them getting worse.

The new guidlines appear to be less restrictive than an earlier version that suggested that three drugs, Aricept, Reminyl, and Exelon, should not be prescribed because they were not cost-effective.

NICE received thousands of letters in protest when that guidance was published.

The ruling is likely to become final by July, and means the three drugs will in future be prescribed on the state health service, but only for those with Alzheimer's disease of moderate severity.

This accounts for approximately 40 percent of all patients, and includes people with a mini mental state examination (MMSE) score of between 10 and 20 points.

Newly diagnosed Alzheimer's patients with a mild version of the disease will not be able to access the drugs.

NICE's actions are being closely watched by governments around the world, who have to increasingly balance the benefits of modern medicines against their price.

The new drugs apparently cost around 1,000 pounds ($1,750) per patient a year.

Andrew Dillon, chief executive of NICE, insists the decision for restricted use had been drawn up after analysis of additional clinical information provided by manufacturers.

But physicians, patient groups and drug companies have criticised the decision as being short sighted and they are concerned that patients in the early stages of the disease will be excluded.

According to experts the MMSE is very much a rough screening tool and should not be used to determine who receives the drugs.

Alzheimer's is a growing problem globaly, and a team of international researchers recently predicted the number of people suffering from dementia was set to double every 20 years and could reach more than 81 million worldwide by 2040.