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NICE reverses Alzheimer's drug stance

Challenging a previous ruling, the UK's health watchdog has recommended Alzheimer's drugs for a wider severity of disease cases in draft guidance

The UK's National Institute for Health and Clinical Excellence (NICE) has issued draft guidance recommending certain Alzheimer's disease (AD) drugs for the treatment of a wider severity of disease cases than previously recommended.

Under the guidance, acetylcholinesterase inhibitors, donepezil (Aricept, Pfizer/Eisai), galantamine (Reminyl , Shire) and rivastigmine (Exelon, Novartis), would be made available in England and Wales for the treatment of mild to moderate cases of AD. This is a change in stance from a 2007 NICE ruling that recommended the drugs only for patients with more advanced cases of AD.

The NICE appraisal committee that issued the draft guidance concluded that the medications – which cost £2.80 per person per day – were cost-effective for milder versions of the disease and should be made available on prescription.

Another drug, memantine (Ebixa, Lundbeck), was also appraised by the committee, with the treatment recommended for patients with severe AD and for some patients with moderate AD.

Sir Andrew Dillon, NICE chief executive, said more information gained from clinical trials involving the drugs was the reason for the body's new decision: "Our increased confidence in the benefits and costs associated with the use of the three drugs for treating mild and moderate stages of the disease has enabled us to make a positive recommendation for their use in mild disease."

Hundreds of thousands of people with AD could be positively affected by the decision, according to Alzheimer's Society, with drugs made available to those previously denied medical treatment.

"This is a momentous day for thousands of people with Alzheimer's and their carers," said Ruth Sutherland, interim chief executive of Alzheimer's Society. "These drugs can help people have a better quality of life at all stages of the condition."

She continued: "Alzheimer's Society welcomes the draft decision and will now be campaigning for more people to have access to the treatments from today."

NICE has previously faced criticism from both Alzheimer's Society and pharmaceutical companies in its decision to limit the use of treaments, with a judicial review taken to the UK courts by Eisai, joint licence holders of Aricept, in 2007.

This review failed to make the NHS fund Alzheimer's drugs for patients in the early stages of the disease, though a later appeal in 2008 ruled that NICE was not transparent enough in its decision-making process.

In June 2009, however, NICE announced that its recommendations on AD drugs would remain unchanged.

The new draft guidance would overturn that decision, with NICE inviting comments on the recommendation up to October 28. The second meeting of the Appraisal Committee will take place on November 25, with final guidance expected in early 2011.

7th October 2010

From: Healthcare

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