A ruling by the national drug watchdog to limit access to an Alzheimer’s drug has been upheld by the High Court.

The drug company Eisai challenged the National Institute for Health and Clinical Excellence (NICE) over its guidance that for most patients Eisai’s drug Aricept was not a cost-effective use of NHS resources.

This was the first legal challenge to a NICE judgment and, except in one aspect, it was a failure. In the High Court yesterday Mrs Justice Dobbs ruled that on five out of six issues raised by Eisai and the Alzheimer’s Society, the challenge failed.

NICE’s decision, she ruled, had not been irrational or unfair, and only in its failure to take account of disability discrimination legislation had NICE’s procedures been wanting. She ruled that the guidance be amended to correct this, but the effects on actual prescriptions will be small.

Campaigners initially claimed a victory. Neil Hunt, chief executive of the Alzheimer’s Society, said: “This judgment is vindication for the thousands of people who have campaigned for fair access to Alzheimer’s drugs.

“The court has ruled that the NICE guidance is discriminatory and must be changed. Patients now have much fairer access to Alzheimer’s drug treatments.”

But the court ruling will not change access at all, except for a few patients with disabilities such as Down’s syndrome, or those with a poor command of English, whose assessments must in future take these factors into account.

David Anderson, who chairs the faculty of old-age psychiatry at the Royal College of Psychiatrists, said that the ruling was bitterly disappointing. “I am astonished that the NICE process has been found to be rational and without perversity in this case. I am pleased that the court recognised that tests used to assess Alzheimer’s disease under the guidance are inaccurate. It seems we will blindly continue to lag behind every country in northwestern Europe in making these treatments available to patients.”

Paul Hooper, the managing director of Eisai UK, said that the company would seek leave to appeal. He said that NICE’s decision for the drugs to be used only in the later stages of Alzheimer’s remained in force, and that he had been denied access to the computer model used to make the assessment of cost-effectiveness.

“The guidance NICE has issued is morally reprehensible,” Dr Hooper said. “They are denying patients access to early treatment and that is wrong. For NICE to deny treatment to patients with mild Alzheimer’s disease is disgraceful.”

Gordon Lishman, the director-general of Age Concern, said that he was extremely disappointed that the High Court had failed to overturn NICE’s decision, meaning that people with dementia would have to get much worse before they could be given help.

“Denying these drugs to people in the early stages of dementia indirectly discriminates against older people, who are most likely to be affected,” he said.

“The drugs can cost as little as £2.50 a day per person and could make day-to-day life far more manageable for thousands of people.”

The court was not asked to rule whether NICE’s decision was right, but on the narrower issue of whether its procedures in gathering and assessing the evidence and hearing the appeal were correctly followed.

Mrs Justice Dobbs ruled that they were, except in “atypical” patients, who might suffer from disabilities or, alternatively, be of such high intelligence that their disease appeared to be less severe and kept them outside the threshold for treatment set by NICE.

Yesterday morning the court heard submissions from both sides on what remedies the court should order to put this right. The plaintiffs argued that the court should quash the guidance and ask NICE to start again, while the defendants took the view that this would be disproportionate and that a simple amendment of a sentence or two in the guidance would suffice.

Andrew Dillon, the chief executive of NICE, said that the judgment strengthened the organisation by endorsing its approach to evaluating drugs. “Alzheimer’s disease is a devastating illness, but the evidence indicates that these drugs are simply not effective for some patients. That is why we also issued advice last year on the broader support that should be provided for people with Alzheimer’s disease and those who care for them, creating core standards for the NHS and care homes that will make a real difference for patients and their families.

“It was always our intention that people with learning disabilities or people whose first language is not English should have equal access to the drugs in the moderate stage of Alzheimer’s disease. We will reissue our guidance to the NHS to make this crystal clear.”

Devastating disease

— There are 700,000 people with dementia in Britain, of which Alzheimer’s disease (named after the German psychiatrist Alois Alzheimer) is the most common

— It is a degenerative disease marked by loss of memory and an increasing inability to communicate, understand and function normally

— There are no cures. Four drugs – Aricept, Exelon, Reminyl and Ebixa – can temporarily slow the development of the disease in some patients

— Some groups, including people with Down’s syndrome, are especially prone to Alzheimer’s

— The 2006 guidance by NICE meant that 96,600 patients with mild Alzheimer’s would be refused treatment that would have been available to them previously

Source: Times database

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