UK watchdog backs limited Alzheimer drug use

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.