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NICE courts controversy

Cost-effectiveness body is slammed by patient groups and industry after adopting an appraisal process for Alzheimer's treatments, which was panned by experts and patients

Patient groups and pharma companies have attacked an internal appeal panel at the National Institute for Health and Clinical Excellence (NICE), after it lent its support to an appraisal process for treatments for Alzheimer's disease, which was ridiculed by experts and patients.

The decision by the appeal panel, which supports the recommendation earlier this year by NICE to deny access to anti-dementia drugs on the NHS to all patients newly diagnosed with mild Alzheimer's disease, is the most recent development in an ongoing debate about patients' access to treatments for Alzheimer's disease and follows an appeal heard by NICE in July.

The Alzheimer's Society is up in arms at the decision and has reacted angrily to the NICE appeal panel, accusing the cost-effectiveness watchdog of papering over major flaws in the final appraisal decision (FAD) by saying it is merely guidance, while ignoring the fact that the drugs can save money in other areas because they do not fall within NICE's remit.

According to the Society the decision is equivalent to telling people with dementia that their lives are not worth £2.50 a day and will have a detrimental impact upon people in the early stages of dementia, who will be forced to wait until their condition deteriorates before receiving the medication they need. Only people with moderate Alzheimer's will have access to anti-cholinesterase drugs, Aricept, Exelon and Reminyl.

Equally, the decision will also have a profound effect on people in the later stages of the disease who, following the NICE recommendation, will be denied access to the only licensed drug proven to alleviate the symptoms of late Alzheimer's, such as aggression and agitation. Ebixa will not be funded on the NHS under the recommendations.

ìNICE have admitted that they have made fundamental errors and that their guidance is discriminatory, yet unbelievably they are still not prepared to change their guidance,î said Clive Ballard, a leading old-aged psychiatrist and director of research at the Alzheimer's Society.

ìIt is disgusting that they are prepared to put preserving their own reputations ahead of doing their job and making effective treatments available to people with Alzheimer's disease. It's now time for the Department of Health to take leadership over this farcical process and ensure appropriate and effective treatments are available for people with Alzheimer's disease,î he added.

The decision has been rejected by the Action on Alzheimer's Alliance, a group of over 30 professional and patient organisations that have condemned the guidance. Dr David Anderson, chair, Faculty of Old Age Psychiatry at the Royal College of Psychiatry said: ìThis is a terrible decision based on a deeply flawed process. I am astonished that the appeals against this guidance have been disregarded.

ìImplementation of this guidance will set the treatment of Alzheimer's disease back 10 years, while the number of sufferers continues to increase rapidly. It is extremely short-sighted to deny these people access to effective treatment,î he noted.

Dr Olivier Brandicourt, managing director of Pfizer UK shares Dr Anderson's disbelief: ìNICE has ignored the evidence of patients, charities, researchers and doctors that these drugs are of benefit in the mild as well as moderate stages of the illness.î

On the back of the appeal panel's decision, NICE has now said that it will delay issuing final guidance for a further five weeks, when it will coincide with the publication of new guidelines on the management of dementia, developed by the Joint Social Care Institute for Excellence and NICE Guideline Development (GDG).

However, this may potentially cause further confusion according to Eisai, the maker of Aricept and its co-promotion partner, Pfizer. To date, the GDG has been openly critical of NICE's position on the treatment of Alzheimer's and it is now not clear if NICE and GDG will make the same recommendations.

ìThis is a sad day for people with Alzheimer's disease in that the rationing body is still proposing to take away the only medicines available for the early stages of Alzheimer's, a most cruel disease, on grounds that are known only to itself,î said Dr Paul Hooper, managing director of Eisai.

ìIt makes no sense medically, it makes no sense economically and it makes no sense to patients and their carers. NICE has failed to listen to the true experts when making its decision,î he continued.

While the recommendations are grave cause for concern, the incident has called in question the appraisal mechanisms employed by NICE and the robustness and transparency of the appeal process. Five separate appeals were heard by the appeal panel: a joint appeal from the Alzheimer's Society, Age Concern, Counsel and Care, Dementia Care Trust and the Royal College of Nursing; a second joint appeal from the Royal College of Psychiatrists and the British Geriatrics Society and three separate appeals from manufacturers of anti-dementia medicines. Yet, in the eyes of onlookers, none of the concerns raised during these appeals have been addressed.

Eisai and Pfizer are now evaluating their options with regard to a judicial review by the High Court and will be considering both the fairness and transparency of this specific appraisal, as well as the NICE appeals procedure.

30th September 2008

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