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news.UK regulator, the National Institute of Clinical Excellence, has angered drug makers and institutions concerned with the treatment of Alzheimer's disease after making preliminary recommendations to limit four drugs used to treat the disease.
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The National Institute of Clinical Excellence (NICE) has recommended that four cholinesterase inhibitors currently licensed in the UK for use in Alzheimer’s disease, donepezil (Pfizer and Eisai’s Aricept), rivastigmine (Novartis’ Exelon), galantamine (Johnson & Johnson’s Reminyl) and memantine (Lundbeck’s Ebixa), should not be used within the National Health Service (NHS) in England and Wales as they are not cost effective.
NICE’s preliminary proposal states that donepezil, rivastigmine and galantamine are not recommended for use in the treatment of mild to moderate Alzheimer’s disease (AD) and that memantine is not recommended for the treatment of moderately severe to severe AD, except as part of ongoing or new clinical studies.
The Royal College of Psychiatrists, the professional and educational body for psychiatrists in the UK and Ireland, has strongly disagreed with these preliminary recommendations.
According to the college, this advice directly contradicts previous NICE guidance in 2001, which made three of the drugs (donepezil, rivastigmine and galantamine) widely available to patients with AD as a standard part of management within the NHS. Since that time, many tens of thousands of patients have received, and obtained benefit from, such medications.
NICE concluded that there is good evidence from clinical trials that the drugs are effective in benefiting AD patients. However, economic analysis concluded that the cost of these drugs (around GBP2.50 per day) put them outside the range of cost-effectiveness that might be considered appropriate for the NHS, given the benefits they provide.
“On average, drugs for Alzheimer’s disease delay the decline associated with the illness by six to nine months. In our opinion, this degree of improvement in a devastating and progressive illness for which no other treatments are available is well worth the modest costs of the drugs,” stated Professor Susan Benbow, chair of the Old Age Psychiatry Faculty.
“Alternative treatments for people with dementia would include antipsychotic drugs for behavioral changes, a class of drugs known to be associated with significant and serious side-effects in this group of patients, unlike cholinesterase inhibitors which are generally very well tolerated,” she continued.
Anti-dementia drugs have been licensed in the UK since 1997, and prior to their widespread prescription throughout the NHS, many families were forced to fund the cost of these drugs through private prescriptions. The college is concerned that should the draft current NICE guidance be adopted, a similar situation would operate once again in England and Wales.
NICE has said that people currently receiving the drugs may continue therapy until it is considered appropriate to stop and the appraisal committee will meet again before preparing the final appraisal determination.