Healthy Skepticism Library item: 10708

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Publication type: news

Bennett R.
NICE challenged over Alzheimer's drugs
Times Online 2007 Jun 25
http://www.timesonline.co.uk/tol/news/uk/health/article1984137.ece

Full text:

The government’s medicines watchdog was accused today of “irrationally and unlawfully” withholding drugs which could help thousands of people suffering from early-stage dementia.

Two pharmaceutical companies and a charity are challenging a controversial decision taken by the National Institute of Clinical Excellence (NICE) to restrict the use of their drugs to people with middle-stage dementia only. It is the first time the watchdog has faced a legal challenge

Opening the four-day case, David Pannick QC, representing Eisai, licensed holder of the drug Aricept, said Alzheimer’s was an appalling disease which was wrecking lives.

Yet there were drugs which could “buy time and quality of life” for sufferers with mild symptoms.

He said the decision process used by NICE was flawed and did not take into account the benefits to carers the drugs might bring.

“There can be no doubt that one cannot over-emphasise the distress and damage caused to patients and to their families by a disease which progressively destroys the personality of the human being, ruins memory, comprehension, communication skills, mobility and the ability to perform simple tasks, until the person that was, sadly, is no more,” Mr Pannick said.

“The inevitable consequence of removing funding for those with mild Alzheimer’s Disease is that the opportunity is lost for delaying the onward march of this appalling disease and maintaining a relatively good way of life for patients as long as possible.”

Eisai and Pfizer, which markets the drugs, say they have not been provided with the full version of the economic model used by NICE to evaluate both clinical and cost effectiveness of the drugs.

The legal action is being backed by the Alzheimer’s Society, which represents 630,000 people with the disease and their carers.

The charity has accused NICE of ignoring totally the proven benefits of the drugs for carers of those with mild symptoms, and grossly underestimating the savings they bring to the state by enabling sufferers to remain in their own homes longer.

It accused NICE of implying carers are far better off when the condition of their sick relative deteriorates so much that they are forced to move into a residential home.

Witness statements read out by Mr Pannick recounted how Alzheimer’s sufferers had had their lives enhanced by the drugs, halting the progress of the disease and helping them re-engage with normal life.

However, the watchdog has argued that at a cost of £2.50 a day they were too expensive when weighed against their benefits to patients, and said the drug companies had not provided a compelling case.

NICE has already watered down an initial decision taken in 2005 that Aricept and two other drugs, Reminyl and Exelon, should no longer be made available on the NHS to any dementia sufferer.

Following public uproar at its decision, it relented and said those with middle-stage dementia could be prescribed the drugs, though not those in the early or late stages.

At the end of the four-day case the Judge, Mrs Justice Dobbs, will reserve her decision in order to give it in writing at a later stage.