Alzheimer's drug challenge launchedDecision by medicines watchdog under fire

25 June 2007

The government's medicines watchdog is facing a major legal challenge in the High Court over its decision not to continue funding anti-dementia drugs on the NHS for patients in the early stages of Alzheimer's disease.

Drug companies supported by the Alzheimer's Society are challenging decisions by the National Institute for Health and Clinical Excellence (Nice).

Nice says it made its recommendations because the drug treatment was shown to be not particularly effective for people with mild Alzheimer's disease, and resources should be put into other treatments available on the NHS.

The four-day case before Mrs Justice Dobbs at London's High Court centres on the use of acetyl cholinesterase inhibitors (AChEIs) in the treatment of Alzheimer's disease.

Acetyl cholinesterase inhibitors

Nice recommended that three anti-cholinesterase drugs - Aricept (donepezil), Exelon (rivastigmine) and Reminyl (galantamine) - should not be prescribed for use by patients in the early stages of the disease.

The drug marketers, Eisai and Pfizer, argue the effectiveness appraisal process was unfair.

They say those consulted by Nice were provided with a 'read only' version of the economic model used by the watchdog to evaluate both clinical and cost effectiveness of AChEIs.

This prevented the companies from re-running models themselves using different impact data and different assumptions from those used by Nice.

'Fundamentally flawed'.

The Alzheimer's Society said before the start of the hearing in London it strongly believed the process used by Nice to reach its decision was 'fundamentally flawed'.

It pointed out that Nice had acknowledged the drugs worked, but said they were not cost effective at £2.50 per person per day.

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