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NICE reversal on Alzheimer's drugs

Decision to exclude patients in mild or severe stages of the disease comes under fire from manufacturers and health campaigners

The National Institute for Health and Clinical Excellence (NICE) has partly backed away from a previous decision to ban the use of three Alzheimer's drugs in the NHS by releasing revised draft guidelines allowing their use in a minority of patients.

The new guidance, which is subject to further consultation but likely to be given the final go-ahead by July, means that Aricept (Pfizer and Eisai), Exelon (Novartis) and Reminyl (Shire) will be prescribed on the state health service for new patients with moderate Alzheimer's. NICE said moderate cases account for about 40 per cent of Alzheimer's patients.

In March 2005, a NICE preliminary ruling called on doctors to stop prescribing the drugs to all new patients on the basis that they were not effective enough. Vehement protests on the part of patients, medics and pharma companies persuaded NICE to review its decision.

NICE chief executive Andrew Dillon said the cost-control body had made the ìright decision, based on all the evidenceî.

ìBy 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,î he said.

NICE spokeswoman Sarita Tamber denied that NICE had bowed under pressure: ìWe always consult on our draft documents before we issue final guidance so people have the chance to highlight issues that we might have missed so we can actually make changes before we set standards for the NHS.î

Although the drug manufacturers and health campaigners welcomed the change of heart, they were critical that it still excludes people with mild or severe Alzheimer's from having treatment on the NHS.

Eisai managing director, Dr Paul Hooper, said that the company did not agree with excluding patients in the early stages of Alzheimer's from treatment.

ìIn every other branch of medicine, the emphasis is on finding and treating early before the illness progresses,î he added. ìYet NICE proposes a different medical approach with dementia. It makes no clinical sense.î

Pfizer MD, Dr Olivier Brandicourt, described NICE's thinking on mild Alzheimer's as ìsomewhat unclearî.

ìWe will be working with them to find a way to ensure all Alzheimer's patients have access to these valuable treatments,î he said. ìOur data show that these medicines are cost effective in early disease.î

A year's treatment of the drugs costs under £1,000 per person, according to Pfizer and Eisai. Since Aricept's inception on the market in 1007, global sales of Alzheimer's drugs have risen to over $3bn a year, according to IMS Health.

NICE also ruled that a fourth Alzheimer's drug, Ebixa, made by Lundbeck, showed insufficient clinical benefit in patients with moderately severe to severe Alzheimer's and should not be used, except in the context of clinical trials.

Since NICE was founded in 1999, it has reviewed 93 drugs, surgical procedures and other treatments; in eight cases it has called for a blanket ban on treatments because their benefits were deemed not to be worth the cost and in 57 cases it has recommended restricted use of a treatment. However, the Institute has always remained adamant that its aim is not to save money but to make health spending more effective.

30th September 2008

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