NICE U-turn on Alzheimer's drugs

NICE has partially reversed its controversial draft recommendation advising against the use of all four drugs licensed to treat Alzheimer's in the UK.

New evidence was provided by the drug manufacturers after NICE's first draft guidance, published last March, suggested that none of the treatments should be used.

The new data convinced the appraisal committee that three of the four licensed treatments, donepezil (Aricept), galantamine (Exelon) and rivastigmine (Reminyl), should be offered to patients with moderate Alzheimer's. But the NMDA-receptor antagonist memantine (Ebixa) is not recommended.

Under the second draft guideline, 40 per cent of Alzheimer's patients would be eligible for drug treatment on the NHS.

NICE chief executive Andrew Dillon said: 'This is a significant change in the advice. Last June, the committee was uncertain whether the evidence supported the use of these drugs or not.

'We asked the drug companies to undertake additional analysis that has persuaded a majority of the committee these drugs are cost-effective for patients with moderate Alzheimer's.'

Clive Ballard, professor of old-age psychiatry at King's College London, and director of research at the Alzheimer's Society, said pressure from the society and other groups, including the DoH, had forced NICE to revisit the evidence.

But he said the draft guidelines remained 'untenable and unethical' for GPs: 'The quality framework requires them to put effort into identifying and following up Alzheimer's patients that they would be unable to offer any treatment to.'

Berkshire GP Dr Patrick Brooke, who has an interest in dementia, said: 'This ruling does not fit with how these drugs are used in other countries.'

He added that denying treatment to patients with mild Alzheimer's could lead to later referrals and worse outcomes.

The evidence considered by the committee showed that for all three acetylcholinesterase inhibitors patients in the moderate or severe groups benefited most, with an average four-point benefit on the Alzheimer's disease assessment scale cognitive subscale, compared with a two-point benefit in patients with a milder form of the disease.

Meanwhile, a review of 23 clinical trials of donepezil involving 5,272 patients undermines the committee's conclusions. It found patients with mild, moderate or severe Alzheimer's benefited equally from treatment and concluded the drug can improve 'cognitive function, activities of daily living and behaviour'.

The consultation period ends on 13 February and NICE expects to issue its final guidance in July.


- Donepezil (Aricept), galantamine (Exelon) and rivastigmine (Reminyl) recommended for patients with moderate Alzheimer's disease The NMDA-receptor antagonist memantine (Ebixa) not recommended.

- Initial prescription by specialist, GPs may take over prescribing afterwards.

- Six-monthly patient reviews.

- Patients already taking any of the drugs licensed in the UK may continue to do so unless they, their carers or a specialist decide otherwise.

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