Alzheimer's Drug Battle Reaches High Court ; HOME

Jun 26, 01:55 AM

Current Headlines: By Jeremy Laurance

A two-year fight to secure access to Alzheimer's drugs for tens of thousands of sufferers reached the High Court yesterday as the Government's medicines watchdog was accused of "irrationally and unlawfully" refusing the treatments.

The National Institute for Health and Clinical Excellence (Nice) was challenged by the Japanese pharmaceutical company, Eisai, which makes one of the drugs, Aricept, to defend its restriction of treatments to those in the moderate stage of the disease.

Alzheimer's sufferers staged a demonstration outside court yesterday at the start of the hearing. Bob Noble, 58, of Eastbourne, East Sussex, who was diagnosed two years ago, said the drugs had changed his life. "Without them I would not be capable of looking after myself," he said.

Nice says the drugs, which cost [pound]2.50 a day, are not cost- effective in the early stages of the disease. It has recommended they only be prescribed when the disease has become more advanced. It says they do not work in all patients and have only a small effect.

The decision last November was a relaxation of a recommendation in 2005 that the drugs should not be funded on the NHS at all. But it did not go far enough for the manufacturers and the Alzheimer's Society, which mounted a campaign involving 8,000 objections to the decision, five appeals and a day of nationwide protests.

At the opening of yesterday's case, the first judicial review of a decision by Nice, David Pannick, QC, for Eisai, said the drugs Aricept, Reminyl and Exelon could delay the progress of Alzheimer's.

The experience of Lillian and Keith Turner, from Hastings, East Sussex, showed what the drugs could do, he said. At the time of Mr Turner's diagnosis in 2004, he was "like a child, completely disorientated, unable to watch television, read or hold a sensible conversation," his wife said in a written statement.

But after six months of taking Aricept he could read and watch television and he was now able to shop, drive and has become vice- chairman of his local Alzheimer's Society branch. Although there were limited resources, Nice had to adopt a fair procedure in deciding how to spend them that respected legal rights and adopted a reasonable analysis of the issues, Mr Pannick said.

The cost of the drugs, quoted by campaigners at [pound]2.50 a day, ignores that they only work in some people, according to Nice - ranging from 15 to almost 50 per cent. There is also a dispute over the potential cost savings when the drugs delay the admission of a patient into residential care. Nice says it costs [pound]520 a week, while the Alzheimer's Society says care can cost up to [pound]1,500 a week. The case may turn on the mathematical model used by Nice to calculate the cost effectiveness of the drugs. Eisai said it was prevented from running the model itself using different assumptions. Nice says there was no unfairness and it ran the model more than 20 times with information supplied by drug companies and the Alzheimer's Society. The hearing is due to last four days.

The annual conference of the British Medical Association passed a motion yesterday saying some rationing of NHS services was inevitable and called for government honesty about it.

The role of Nice

The decision to restrict the drugs has been the most controversial in Nice's eight-year history. It was set up in 1999 to advise the NHS on how to spend its funds. Its chairman, Sir Michael Rawlins, insists this is an ethical requirement as every pound spent on ineffective treatment is denied to another patient. He is a clinical pharmacologist and doctor and his appointment, and that of Nice's board, is approved by the Secretary of State. Of the more than 400 products reviewed since 1999, Nice has banned between of eight and 10. In almost two thirds of the rest it has recommended some restriction. The net effect has been to add at least [pound]1bn to the NHS drugs budget. Critics say that its focus is too narrow - for instance, in this case it concentrated on clinical improvement and not on gains such as a reduced burden on carers. They also challenge its arbitrary cost-effectiveness threshold, set at [pound]30,000 per quality adjusted life year - a measurement of the quality of life. England is one of the few countries that has a rigorous assessment process for new drugs, but other countries are following its lead. One reason why the drug companies are challenging Nice in the courts is because they know that its influence extends well beyond these shores.

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