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UK watchdog backs limited Alzheimer drug use

Posted on: Monday, 23 January 2006, 07:56 CST

By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON (Reuters) - Britain's cost-effectiveness watchdog NICE said on Monday that Alzheimer's drugs which can help, but not cure, some patients should be used in a minority of people with the degenerative brain disease.

The decision is a partial climbdown by the National Institute for Health and Clinical Excellence (NICE), which last year suggested so-called anti-cholinesterase drugs were not worth the money for any patients.

The new guidance, which is subject to further consultation but is likely to become final by July, means three drugs will in future be prescribed on the state health service -- but only for those with Alzheimer's disease of moderate severity.

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

Newly diagnosed Alzheimer's patients with mild disease will not get access to the medicines.

The NICE deliberations have been monitored by governments around the world, who increasingly have to weigh up the benefits of modern medicines against their price. The drugs cost around 1,000 pounds ($1,750) per patient a year.

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

"By going the extra mile and asking the drug companies to delve deeper into their clinical trial data, we have been able to identify the right way to use these medicines," he said.

"People with Alzheimer's will now receive these drugs when they can help them most."

NICE FOR SOME

But physicians, patient groups and drug companies criticised the decision as short sighted and said it was worrying that patients with early disease will be excluded.

"In every other branch of medicine, the emphasis is on finding and treating early signs before the illness progresses. Yet NICE proposes a different medical approach with dementia. It makes no clinical sense," said Dr Paul Hooper, the managing director of Eisai Co Ltd.

Pfizer Inc and Eisai Co Ltd's Aricept is the market leader among anti-cholinesterase treatments.

Professor Clive Ballard, of the Alzheimer's Society, described it as an appalling decision.

"It's unethical to withhold treatment from people," he told a news conference.

Dr David Wilkinson, of the Royal College of Psychiatrists, said the MMSE is a rough screening tool and should not be used to determine who receives the drugs which are "very effective and work quickly."

Rival dementia products include Reminyl, from Johnson & Johnson and Shire Pharmaceuticals Group Plc, and Novartis AG's Exelon, both of which are used like Aricept to treat mild to moderate Alzheimer's.

A fourth drug, Ebixa, is made by Lundbeck and is given to patients with more serious disease. But Dillon said there was insufficient evidence of Ebixa's clinical benefit in this group and it should therefore not be used, except in the context of clinical studies.

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

Source: REUTERS

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