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Bitter blow as court rules Alzheimer's drug ban still stands
09 August 2007
The High Court ruled that the health rationing watchdog will not have to reinstate drugs for those with "mild" symptoms.
Mrs Justice Dobbs said the National Institute for Health and Clinical Excellence had not acted unfairly and irrationally in formulating its guidance to health trusts.
NICE will, however, have to rewrite advice that could have discriminated against some sufferers.
Campaigners said patients will now effectively have to prove their dementia has worsened before qualifying for free treatment.
Doctors said the decision means Alzheimer's sufferers in England will continue to receive the worst treatment in Western Europe.
Each year, up to 100,000 are denied funding for three drugs which cost just £2.50 a day and can slow the decline into dementia.
The court challenge from the Alzheimer's Society, funded by Daily Mail readers, followed a record 11,000 protests from sufferers, carers and doctors.
It was the first time NICE guidance has been the subject of judicial review.
The drugs ban was brought in last year in England and Wales even though the drugs - Aricept, Exelon and Reminyl - remain freely available in Scotland.
NICE says they are not cost-effective in the early stages of the dis-ease and patients must develop "moderate" symptoms before receiving free prescriptions.
Eisai, the Japanese company which makes Aricept, and Pfizer which distributes the drug in Britain, were also represented at the case, which was heard over four days in June.
NICE was accused of acting "irrationally and unlawfully" and of producing a "flawed" decision.
The Alzheimer's Society said the benefits of the drugs for carers of those with mild symptoms were ignored.
Savings made by enabling sufferers to stay in their own homes for longer were hugely underestimated.
The society also claimed the memory scoring system used to decide which patients received drugs was inflexible and discriminatory.
In her ruling yesterday, Mrs Justice Dobbs said she recognised drugs might help but that it was not for her to decide whether they should be made available on the NHS.
She ruled that NICE had acted unreasonably by using mental scoring alone to determine a patient's state. Those with learning disabilities or for whom English is a second language could lose out, she said.
Professor Sir Michael Rawlins, chairman of NICE, said the High Court had found in its favour on five out of six grounds.
He admitted the drugs were "clinically effective for some people" in early stages of the disease but said the Health Service had finite resources.
Neil Hunt, of the Alzheimer's Society, said: "We have won the very important point that NICE guidance is unlawful because it discriminated against significant groups of people.
"However, the result is deeply disappointing for everyone in the early stages of Alzheimer's and their carers.
"Without further change to the guidance, people in the early stages of the disease will still be refused drugs because NICE considers that these people are not worth £2.50 a day.
"This is insulting and devastating news. People will be forced to deteriorate before they get the treatment they need. Is this the sort of society we want to live in?"
The judge rejected applications to appeal, meaning the Alzheimer's Society and drugs companies must now decide whether to petition the Court of Appeal directly.
The judge ordered NICE to pay 40 per cent of the drugs companies' costs in addition to its own, leaving it with a likely bill of £540,000.
That would pay for 3,700 to have a year's supply of the drugs in question.
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