NICE hears appeals over dementia drugs

The National Institute for Health and Clinical Excellence (NICE) last week heard five appeals over two days against its decision to restrict the use of drug treatments for Alzheimer's disease to patients with moderate stages of the condition.

The Alzheimer's Society organised a demonstration in June against NICE's revised guidance on dementia drugs

Credit: MARK THOMAS

In its original guidance, issued in January 2001, NICE recommended that the drugs donepezil, rivastigmine, and galantamine could be prescribed for people with mild and moderate stages of the disease, defined as having a score of 12 or more on the mini-mental state examination, where ahigher score indicates a milder disease (BMJ 2001;322: 190).

But in revised guidance proposed in May this year, NICE recommended that the drugs should be used only in people with moderate disease. This was defined as those with a score of between 10 and 20, thus setting an upper limit and excluding people with the mildest form of the disease. Another drug, memantine, is not recommended for use outside clinical trials.

The Alzheimer's Society, which launched a joint appeal with Age Concern, Counsel and Care, the Dementia Care Trust, and the Royal College of Nursing, claims the advice is discriminatory because it is based on the mini-mental state examination score, which varies depending on education and race. It also says that restricting the drugs will lead to increased prescribing of unlicensed sedatives to treat people with dementia.

The society has charged NICE with overestimating the cost of prescribing the drugs because it has assumed that doctors will continue to prescribe them even if patients are not responding to them. “This is simply not what happens in reality,” it says in a statement. NICE had also ignored the savings that the drugs can bring in reduced caring time.

Leading the appeal, Clive Ballard, the director of research at the Alzheimer's Society, said last week, “The NHS has long been the envy of the world, but today the world is watching to see if it will return to the dark ages of dementia care.”

Other appellants included drug manufacturers Eisai, Lundbeck, and Shire Pharmaceuticals, while the Royal College of Psychiatrists and the British Geriatrics Society launched a joint appeal.

In a separate action, Eisai, the manufacturer of the Alzheimer's disease treatment donepezil (Aricept), has referred the information commissioner to the parliamentary ombudsman for failing to tackle the refusal by NICE to disclose the calculations behind its decision on the anti-dementia drugs.

According to the company, NICE has repeatedly refused to make available the new mathematical model it used to reach the conclusion that antidementia medicines are no longer a cost effective treatment in the early stages of Alzheimer's disease.