NICE's decision to deny cholinesterase inhibitors to newly diagnosed patients with mild Alzheimer's has led patients and clinicians to question whether the independent NHS advisory body is truly considering clinical and cost-effectiveness, or just looking at cost.
GPs and patient groups were dismayed that in the final draft appraisal of drugs for Alzheimer's disease, issued last month, NICE maintained that cholinesterase inhibitors could be given to patients in the moderate stage of disease, but not to those with mild Alzheimer's.
There are concerns that if this is not changed before the final appraisal next month, GPs will have no effective treatment for patients with mild Alzheimer's.
Cardiff GP and chairman of GPC Wales, Dr Andrew Dearden said the decision 'seems to fly in the face of good practice'.
'I think most people were hoping to use them earlier rather than later.
This is another case where NICE is supposed to look at cost-effectiveness, but is looking at cost, not effectiveness,' he said.
Value for money
But NICE chairman Professor Sir Michael Rawlins denied this. 'We base all our advice on cost-effectiveness. We don't look at cost, we look at value for money,' he said. 'Our guidelines are a genuine attempt to advise doctors and patients on the best way to achieve the highest attainable health outcomes.'
Wrangling over who will be able to get cholinesterase inhibitors on the NHS began in December 2004 when NICE issued the first draft review of the technology appraisal.
This ruled that donepezil, galantamine and rivastigmine were not cost-effective for any form of Alzheimer's disease, which went against 2001 guidance that allowed use of the drugs in all stages of Alzheimer's disease.
But NICE did take into account appeals against the preliminary document, including those received from the DoH.
After reviewing the evidence, NICE conceded in January that it would be cost-effective to give cholinesterase inhibitors to Alzheimer's patients if they had a mini-mental state examination (MMSE) score of 10-20.
Appeals to offer the drugs to patients with an MMSE of 20-24 have been ignored.
North London GP Dr Steve Iliffe, a member of the NICE dementia clinical guidance group, said the ruling reflected the finding that, although cholinesterase inhibitors were clinically effective in mild Alzheimer's, they were only cost-effective in moderate disease.
Discussing why patients with mild Alzheimer's would not be entitled to the drugs under the draft guidance, he said: 'We have to be realistic.
There are small gains to be had at very high cost.'
But the Alzheimer's Society refuted the claim that cholinesterase inhibitors are not cost-effective for early treatment of Alzheimer's disease. Professor Clive Ballard, director of research, said that allowing this therapy would cost the NHS no more than £5 million a year.
'I cannot see how it is an evidence-based decision,' he said.
'NICE has certainly not responded to the points we have raised,' he added.
'What the DoH asked for after the initial draft guidelines was a responder analysis. NICE has included a responder analysis in the document but this has not influenced its recommendations.'
Some patient groups believe that NICE is doing a good job of taking appeals into account. The charity Breast Cancer Care has welcomed NICE's preliminary appraisal on aromatase inhibitors, published last month, that approved use of the drugs in women with early oestrogen-receptor positive breast cancer.
Anna Wood, policy and campaigns manager for the charity, said organisations often brought patient surveys to the consultation table to demonstrate patients' views about the availability of certain drugs.
'NICE is tending to involve patients, which is important but a daunting experience for them,' she added.
James Raftery, professor of health technology assessment at the University of Southampton, wrote in the BMJ: 'Overall NICE must be judged to have succeeded in surviving some controversial decisions. Although clinicians have understandably feared blanket restrictions, these have been fairly rare.'
Sir Michael added that while adherence to NICE guidelines has to improve, all the technology appraisals issued so far have been implemented to an extent.
'I think it is as fair as any system in the world. No system in the world is as open and transparent as we are,' he said.
NICE technology appraisals
Live links at GPonline.com.