Alzheimer's drugs appeal refused

Two pounds and fifty pence per day per patient is too expensive for the NHS!

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 pounds-per-day drugs. But NICE said studies showed the drugs "did not make enough of a difference". NICE guidelines cover England and Wales, but the health bodies in Scotland often follow suit.

The body has also ruled another drug, memantine, should be used only in clinical studies for people with moderately severe to severe Alzheimer's disease. Eisai and Pfizer, who produce donepezil, also known as Aricept, said they were considering whether to seek a judicial review of the decision.

About 750,000 people 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. Galantamine is also known as Reminyl, rivastigmine as Exelon and memantine as Ebixa.

NICE guidance in 2001 recommended the drugs - which can make it easier to carry out everyday tasks - should be used as standard. However, in July 2005 it said access to the drugs should be restricted because they were not good value for money. It has now issued its final guidance, which will apply only to newly-diagnosed patients. Those already taking the drugs will continue to do so.

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. "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." He told the BBC the appeal was "not designed to re-run the whole evaluation", but that "the appeal panel is to make sure the process has been followed properly".

Action on Alzheimer's, an alliance of more than 30 professional and patient organisations, reacted angrily to the ruling. "The decision will force patients to wait until their condition deteriorates into a state of fear and confusion before receiving drugs that work," it said. Speaking on the BBC's Today programme, Professor Clive Ballard, from the Alzheimer's Society, claimed there were "a number of clear errors during the [Nice] appeal process" that did not appear to have been "addressed". He said: "I think that is a very serious allegation but I believe that to be true."

Help the Aged said one in five people over 80 were affected by dementia and the number of people living with the disease was set to double in a decade. Jonathan Ellis, senior policy manager at the charity, said: "It cannot be right to allow the health of thousands of older people to deteriorate on the altar of cost." A Department of Health spokesman said it would be "entirely inappropriate" to overrule NICE's decision.

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FEW GOOD HOSPITALS IN THE NHS

Quality standards and financial management in the NHS still need improvement, according to a hard-hitting report into the service. More than half of all NHS trusts in England provide services that are only weak or fair, and four fifths fall into the same category for their use of resources.

The ratings are the first produced by the Healthcare Commission under a system that has replaced star ratings. The criteria are broader and tougher, which is reflected in the results. Among hospitals, 11 qualify as excellent and 12 are described as weak in quality of service. Primary care trusts (PCTs) come out even worse: only six deliver excellent services and 24 are weak.

The new scales offer four rungs, roughly corresponding to the old three, two, one or zero stars. Services are assessed as excellent, good, fair or weak, and a similar scale is used to measure financial management, described as "use of resources". Not a single PCT wins the accolade of excellent for financial management and 124 are described as weak. Among ambulance trusts, not one is deemed excellent in either category.

The report will make unhappy reading for ministers, who have argued that the extra money going into the NHS is having real effects. The Healthcare Commission agrees: it sees a lot of positives in the findings and says that more demanding criteria, rather than declining performance, are behind the gloomy ratings.

The commission ranked 570 trusts in England, including PCTs, acute hospital trusts, mental health trusts and ambulance trusts. It concluded that 60 per cent were weak or needed to improve. Only two hospitals - Harrogate and District NHS Foundation Trust and the Royal Marsden Hospital in London - gained excellent ratings for services and use of resources. Eight scored weak in both categories. Overall, 24 trusts were ranked as weak for both quality of services and use of resources. For these - eight hospital trusts, 11 PCTs, four ambulance trusts and one mental health trust - the strategic health authorities would be demanding an action plan to put things right within 30 days.

Anna Walker, the chief executive of the commission, said that there were examples of good work, but added: "The NHS does need to raise its game to ensure a universal guarantee that general standards on both quality of services and use of resources are being met. What this assessment is about is systematically looking at each of these trusts to see how they are performing. What we are saying about the weak ones is not that they are unsafe but that they do have issues that they need to address quickly."

All trusts that ran a deficit in 2005-06 were automatically rated as weak in use of resources. But many, especially among the PCTs, would have scored the same even if they had not run a deficit, because their financial management was poor, Gary Needle, head of the annual health check at the commission, said. Ms Walker said: "This is a worrying picture of an NHS where financial management is not good enough. There are too many weak trusts, which failed to manage finances properly and too many fair trusts, which means that there is room for improvement. "It is no secret that the NHS has struggled with finances over the past year, but this assessment shows it is not only deficits that are the problem. It shows that many organisations do not have adequate financial systems in place. "Patients' care will suffer in the end if this is not put right."

The commission examined quality of services in a variety of ways. They included 24 core standards, looking at areas such as safety, clinical effectiveness and patient focus. Also incorporated were the old targets, mostly concerned with waiting times, where trusts did relatively well, and new targets, such as promoting good health, reducing obesity and helping people to give up smoking, where they did less well.

Patricia Hewitt, the Health Secretary, urged the NHS to redouble its efforts to meet patients' expectations. "The best of the NHS is among the best in the world and we should all be proud of its achievements," she said. "But I want to see the best everywhere. "This is the toughest and most comprehensive assessment of the NHS and it takes forward the commitment we made to patients and the public to provide them with detailed and easily understandable information about the performance of their local health services."

Nigel Edwards, director of policy at the NHS Confederation, said that the spread of results was proof that the latest round of reorganisations had adversely affected services. "Foundation trusts, who have not been reorganised and have extra freedoms to manage their own affairs, have been able to get on with the job and improve services, as the health check shows," he said.

Niall Dickson, chief executive of the King's Fund health think-tank, said: "There is clearly a mountain to climb here, especially in financial management: in part a legacy of the health service not grappling with underlying deficits early enough."

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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