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| Version 1 | Version 2 |
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| Alzheimer's drugs appeal refused | Alzheimer's drugs appeal refused |
| (about 1 hour later) | |
| Alzheimer's disease groups have condemned a decision by the NHS drugs watchdog to reject their appeal for greater access to certain drugs. | Alzheimer's disease groups have condemned a decision by the NHS drugs watchdog to reject their appeal for greater access to certain drugs. |
| The National Institute for Health and Clinical Excellence said donepezil, rivastigmine and galantamine could be used to treat moderate stage disease. | |
| Campaigners had argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs. | Campaigners had argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs. |
| But NICE said studies showed the drugs "did not make enough of a difference." | But NICE said studies showed the drugs "did not make enough of a difference." |
| This blatant cost-cutting will rob people of priceless time Neil Hunt, Alzheimer's Society Drug 'improved our lives' | This blatant cost-cutting will rob people of priceless time Neil Hunt, Alzheimer's Society Drug 'improved our lives' |
| It has also ruled another drug, memantine, should only be used in clinical studies for people with moderately severe to severe Alzheimer's disease. | It has also ruled another drug, memantine, should only be used in clinical studies for people with moderately severe to severe Alzheimer's disease. |
| Eisai and Pfizer, who produce donepezil (Aricept) said they were "evaluating their options with respect to judicial review by the High Court" following NICE's decision. | Eisai and Pfizer, who produce donepezil (Aricept) said they were "evaluating their options with respect to judicial review by the High Court" following NICE's decision. |
| Around 750,000 in the UK are estimated to have dementia. But only 78,000 patients take donepezil, rivastigmine and galantamine, with two thirds of those taking donepezil. | Around 750,000 in the UK are estimated to have dementia. But only 78,000 patients take donepezil, rivastigmine and galantamine, with two thirds of those taking donepezil. |
| Restrictions | Restrictions |
| NICE guidance in 2001 recommended the drugs, which can make it easier to carry out everyday tasks, should be used as standard. | NICE guidance in 2001 recommended the drugs, which can make it easier to carry out everyday tasks, should be used as standard. |
| Galantamine is also known as Reminyl, rivastigmine as Exelon and memantine as Ebixa. | Galantamine is also known as Reminyl, rivastigmine as Exelon and memantine as Ebixa. |
| But in July 2005, NICE said access to the drugs should be restricted because they were not good value for money. | But in July 2005, NICE said access to the drugs should be restricted because they were not good value for money. |
| It has now issued its final guidance. | It has now issued its final guidance. |
| Andrew Dillon, chief executive of NICE, said: "Alzheimer's is a cruel and devastating illness and we realise that today's announcement will be disappointing to people with Alzheimer's and those who treat and care for them. | Andrew Dillon, chief executive of NICE, said: "Alzheimer's is a cruel and devastating illness and we realise that today's announcement will be disappointing to people with Alzheimer's and those who treat and care for them. |
| "But we have to be honest and say that, based on all the evidence, including data presented by the drug companies themselves, our experts have concluded that these drugs do not make enough of a difference for us to recommend their use for treating all stages of Alzheimer's disease. | "But we have to be honest and say that, based on all the evidence, including data presented by the drug companies themselves, our experts have concluded that these drugs do not make enough of a difference for us to recommend their use for treating all stages of Alzheimer's disease. |
| "We have recommended the use of these drugs where they have the potential to make a real difference, which is at the moderate stage of the illness." | "We have recommended the use of these drugs where they have the potential to make a real difference, which is at the moderate stage of the illness." |
| 'Fundamental flaws' | 'Fundamental flaws' |
| Action on Alzheimer's, an alliance of more than 30 professional and patient organisations, reacted angrily to NICE's ruling. | Action on Alzheimer's, an alliance of more than 30 professional and patient organisations, reacted angrily to NICE's ruling. |
| "The decision will force patients to wait until their condition deteriorates into a state of fear and confusion before receiving drugs that work. | "The decision will force patients to wait until their condition deteriorates into a state of fear and confusion before receiving drugs that work. |
| "There is evidence that these drugs work at all stages of the disease, but NICE proposes to restrict their use on grounds of cost." | "There is evidence that these drugs work at all stages of the disease, but NICE proposes to restrict their use on grounds of cost." |
| Neil Hunt, chief executive of the Alzheimer's Society, added: "This blatant cost-cutting will rob people of priceless time early in the disease and later clinicians will have no choice but to use dangerous sedatives that increase the risk of heart disease and stroke." | Neil Hunt, chief executive of the Alzheimer's Society, added: "This blatant cost-cutting will rob people of priceless time early in the disease and later clinicians will have no choice but to use dangerous sedatives that increase the risk of heart disease and stroke." |
| He said there had been "fundamental flaws" in NICE's appraisal process, and called on the government to step in. | He said there had been "fundamental flaws" in NICE's appraisal process, and called on the government to step in. |
| But a Department of Health spokesman said it would be "entirely inappropriate" to over-rule NICE's decision. | But a Department of Health spokesman said it would be "entirely inappropriate" to over-rule NICE's decision. |
| Dr Anthony Pelosi, a consultant psychiatrist at Hairmyres Hospital, East Kilbride, said adequate research had not been carried out into the effects of the drugs. | Dr Anthony Pelosi, a consultant psychiatrist at Hairmyres Hospital, East Kilbride, said adequate research had not been carried out into the effects of the drugs. |
| "We still do not know, about 10 years after they became available, whether these medications are effective enough to justify their use in Alzheimer's disease at mild, moderate and severe stages. | "We still do not know, about 10 years after they became available, whether these medications are effective enough to justify their use in Alzheimer's disease at mild, moderate and severe stages. |
| "Do they improve most patients' overall quality of life? What about their effects on quality of life of the relatives? Do the tablets slow down the time until nursing home care is required? | "Do they improve most patients' overall quality of life? What about their effects on quality of life of the relatives? Do the tablets slow down the time until nursing home care is required? |
| "We do not really know the answers to these questions." | "We do not really know the answers to these questions." |
| NICE guidelines cover England and Wales, but the health bodies in Scotland often follow suit. | NICE guidelines cover England and Wales, but the health bodies in Scotland often follow suit. |
| This final guidance will only apply to newly diagnosed patients. | This final guidance will only apply to newly diagnosed patients. |
| Those already taking the drugs will continue to do so. | Those already taking the drugs will continue to do so. |