The National Institute of Clinical Excellence (NICE), who last week rejected appeals to allow patients with mild Alzheimer's to receive the life-changing medication donepezil (Aricept®), will hopefully re-appraise their decision in three-years time, according to neurologist Professor Robert Kerwin in an article published in the November issue of the medical journal Future Neurology.
Kerwin evaluated recent research published in the Lancet that may not have been taken into account by the NICE committee. In this study, nursing home patients with severe Alzheimer's disease were administered with donepezil, or a placebo drug, and were observed for 6-months. Those patients receiving donepezil treatment showed significantly improved cognitive function, compared with those patients not receiving the drug, despite recommendations by NICE not to prescribe donepezil to this patient group.
Kerwin also evaluates recent data suggesting that the drugs are effective in patients with milder forms of Alzheimer's disease. The recent 2005 NICE revised guidelines for cholinesterase inhibitors, the class of drug that donepezil and other Alzheimer drugs rivastigmine(Exelon®/Prometax®) and galantamine (Reminyl®) belong to, state that these drugs can only be administered to patients with moderate Alzheimer's, for whom NICE believe the evidence is strongest. At the same time NICE withdrew its recommendations for the use of these drugs for patients with mild-to-moderate Alzheimer's. Memantime (Exiba®), belonging to another class of drugs, is not recommended to Alzheimer's sufferers, but is restricted to ongoing clinical trials and may be possible treatment in the future.
"NICE's decisions are based upon the economic health calculations that they do, which are balanced against clinical benefit. Even though the drugs do work in the long-term, patients do progress to requirements of alternative care that do not necessarily lead to savings within the NHS." Commented Kerwin, who is a Professor of Clinical Neuropharmacology at the Institute of Psychiatry, London.
750,000 people are estimated to suffer from Alzheimer's disease in the UK alone, with 78,000 of these receiving rivastigmine, galantamine and memantine; a further 2-thirds of sufferers take donepezil. Since NICE's original 2001 guidelines that this family of drugs should be made broadly available within the UK NHS for mild-to-moderate Alzheimer's disease, prescriptions have risen sharply and many sufferers have experienced a welcome relief from the debilitating symptoms of memory loss and cognitive decline. In 2005, NICE reviewed their previous decision based on the cost effectiveness and clinical benefit of such drugs in mild- and severe-Alzheimer's sufferers, and ruled that the drugs should be limited only to patients with moderate forms of the disease. This is only applicable to newly diagnosed patients. Despite uproar from patient groups appealing this decision, NICE stuck by their guidelines and last week issued a statement over-ruling the appeal.
"It is a bizarre decision," continued Kerwin, "the economists in the appraisal may well have had sway over the clinicians in the appraisal, and the clinicians may, on the other hand, have said that the drugs do help mild patients to quite a significant degree. I personally think NICE would have made a mistake over this decision if it is dominated by health economists rather than clinicians, however I have no knowledge of the final deliberations of the NICE committee." Kerwin, who once sat on the NICE committee appraising these drugs, points out that they would only have analysed current data in their review and that more recent data, published in the gap between the final draft of the appraisal and the appeal, would possibly not have been taken into account. NICE would only have evaluated their process and the methods used to reach such a decision.
"These drugs work in ways that are not predictable for severe Alzheimer's disease patients, which suggests there is an added mechanism. Mild patients will always do better, everybody knows that, but the economic sums don't quite fully add up in terms of cost. I believe that progression, when measured economically rather than clinically, may not be very impressive."
Despite the recent uproar, Kerwin remains hopeful that with new data, such as those analysed in his article on severe Alzheimer's disease patients, NICE could potentially reverse their decision due to their working principal of 'positive review' on a 3-yearly cycle. Future Neurology is published by Future Medicine an imprint of the Future Science Group.
Journal
Future Neurology