Alzheimer's Drug Treatments Issue In Britain's High Court

Pharmaceutical companies and a group of patients with Alzheimer's disease went to Britain's High Court on Monday in order to force National health service to give all patients access to three drug treatments for the Alzheimer's disease which are Aricept, Reminyl and Exelon- three inhibitors.

Drug companies Eisai Co. Ltd. and Pfizer Inc., with the Alzheimer's patients, want to discuss a decision by the government's medicines watchdog not to approve a group of acetyl cholinesterase inhibitor drugs for patients in early stages of the disease. Japanese pharmaceutical company, Eisai, makes one of these drugs, Aricept.

Alzheimer's sufferers started a demonstration outside court yesterday at the start of the hearing. 58 years old Bob Noble, who was diagnosed two years ago, said the drugs had changed his life. "The drugs give me a way forward, to rebuild my life to an acceptable level," he said. "It is absolutely critical. Without the drugs I would not be capable of looking after myself."They are being unfair because they are discriminating against young people, newly diagnosed, by not approving drugs that would give them a good quality of life." he said.

The National Institute for Health and Clinical Excellence (Nice) says the drugs, which cost 2.50 pounds ($5) per patient per day are not cost effective in the early stages of the disease. It is recommended to prescribe it only when the disease has become more advanced. It says they do not work in all patients and have only a small effect.

There is also a dispute over the potential cost savings when the Alzheimer's disease treatment drugs delay the admission of a patient into residential care. Nice says it costs £520 a week, while the Alzheimer's Society says care can cost up to £1,500 a week.

"For Alzheimer's disease, drugs are only part of the care that needs to be offered," said Andrew Dillon, chief executive of NICE. "Non-drug interventions have an important part to play and the evidence indicates that drugs are simply not effective for some patients."

The drug companies and the Alzheimer's Society accuse NICE for telling patients they must get worse before they can be treated.

At the opening of 25 June’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 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.

About 100,000 new cases are being diagnosed each year, and they claim that Nice is ignoring the proven benefits of the drugs. They want to force Nice to reconsider its decision that the drugs be given only to moderate and severe Alzheimer's sufferers.

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.

During the four-day hearing Nice will argue that there was no unfairness.

Andrew Dillon, the chief executive of Nice, said: "Our consultation, decision-making and appeals processes are fair."

England is one of the few countries that has a strange assessment process for new drugs, but other countries are following its lead. Drug companies are challenging Nice in the courts with the reason they know that Nice influence extends well beyond these shores.

source:www.emaxhealth.com