The UK’s clinical- and cost-effectiveness body, the National Institute for Clinical Excellence, has come under fire yet again, this time for a preliminary decision not to recommend Eisai’s Aricept (donepezil), Novartis’ Exelon (rivastigmine) and Shire and Johnson & Johnson’s Reminyl (galantamine) for use in the treatment of mild-to-moderate Alzheimer’s disease.

In its appraisal consultation document, which forms the basis of final guidance, but is subject to change during a consultation period, NICE also said that it would not be recommending Lundbeck’s Ebixa (memantine) for the treatment of moderately-severe to severe AD, except as part of ongoing or new clinical studies. However, patients currently receiving one of the four products, either routinely or as part of a clinical trial, can continue treatment until it is considered appropriate to stop.

The proposal effectively reverses a 2001 decision in which NICE said that Aricept, Reminyl and Exelon could be used on the NHS to treat AD patients [[22/01/01b]]. Eisai condemn the draft appraisal, saying that it would “effectively remove hope of treatment benefit for NHS patients with Alzheimer’s disease.” Paul Hooper, the firm’s managing director, said the proposal was “astounding.” He added: “It is not a lottery of care – people are being denied a chance even to buy a ticket… If NICE adopt this proposed guidance document, [it] will introduce chequebook prescribing where only those who can afford to pay for these medicines will get them.” Dr Hooper added: “We must hope that common sense prevails and at its final decision stage NICE rejects this damaging proposal.”

Neil Hunt, chief executive of the Alzheimer’s Society, said: “We are shocked by NICE’s initial recommendations, which, if finally approved, will deny thousands of people with dementia the only drug treatment available to them. These drugs are not a cure. They don’t work for everybody. But they can make a real difference to quality of life and their importance to many carers and people with dementia cannot be overestimated… NICE seems to have concluded that people with dementia are a group that it is not worth spending money on.”

NICE will again review its recommendation in March, with final guidance expected in July this year.

AD is the most common form of dementia – a chronic progressive mental disorder, affecting functions such as memory, thinking and orientation. AD develops slowly but steadily over a number of years with progression from diagnosis to death generally taking between five and seven years. In 2002, an estimated 290,000 people in England and Wales were suffering from AD. The incidence rate for AD in those over 65 years old has been estimated at 4.9 per 1000 person-years in the UK. Between 50% and 64% are estimated to have mild to moderate disease, while approximately 50% of patients have moderately severe to severe AD.