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Industry and campaigners condemn NICE Alzheimer's decision

Guidance recommends restricting access to patients until they reach moderate stage of condition

The National Institute for Health and Clinical Excellence (NICE) has stuck to its interim decision restricting access to three Alzheimer's drugs, causing outrage among pharma manufacturers and health campaigners.

The cost-benefit regulatory watchdog announced it will recommend that Aricept (Pfizer and Eisai), Exelon (Novartis) and Reminyl (Shire) should not be provided to patients with Alzheimer's unless they have reached a moderate stage of the condition.

A fourth drug, Ebixa (Lundbeck), used to treat patients with severe Alzheimer's, will now only be available for those with moderate symptoms.

The proposals are subject to an appeal period until June 15; the final guidance will only apply to newly diagnosed patients and those already taking the drugs can continue to do so.

Professor Clive Ballard, of the Alzheimer's Society, said that the NICE recommendations would force doctors into ìthe impossible position of watching patients deteriorate before they prescribe drugs they know will helpî.

ìFor what other condition would you wait until people decline so much they can no longer look after themselves before giving them treatment?î he said.

Neil Hunt, spokesman for the Action on Alzheimer's Drugs Alliance, which represents over 30 charities and professional organisations, described the NICE decision as ìoutrageousî.

ìIt will rob families of precious time in the early stages of dementia and deprive people of comfort and dignity in the final stages of their illness,î he said.

He added that the withdrawal of Ebixa, the only treatment for distressing behavioural symptoms in late dementia, was a ìdisgraceful double blowî.

Eisai said it would be lodging an appeal with NICE.

ìWhat NICE are proposing is perverse,î said the firm's UK managing director, Dr Paul Hooper. ìTheir own draft guidelines call for earlier intervention in dementia, yet they seek to withhold the only treatments which have been shown to hold back the progression of this devastating condition.î

John Freeman, managing director of Shire's UK commercial operation, said his firm ìfundamentally disagreeî with the decision.

ìShire Pharmaceuticals is considering all options following the issue of this final appraisal, including the option to appeal,î he said.

Initial NICE guidance on the use of Aricept, Exelon and Reminyl in 2001 recommended their use for all patients, with treatment stopping as soon as they no longer had an effect.

In July last year, NICE said access to the drugs should be restricted because they did not represent good value for money. Earlier this year, it partly backed away from this decision by releasing revised draft guidelines allowing them to be prescribed on the NHS for new patients with moderate Alzheimer's.

30th September 2008

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