UK advisory agency recommends against use of Alzheimer drugs
The independent treatment advisory agency of the United Kingdom's government-funded National Health Service (NHS) has issued a draft recommendation against use of currently approved drugs to treat Alzheimer's disease. The drugs covered in the draft are donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl) and memantine (Namenda).
The agency, known as the National Institute for Clinical Excellence (NICE), bases its recommendation on an economic analysis showing that none of the drugs produces sufficient benefit to justify the cost of treatment.
NICE will accept public comments on the recommendation until March 22, 2005. At a future date yet to be determined, NICE will meet to re-evaluate the draft in light of public feedback and issue final guidance. If the final version continues to advise against these drugs, the NHS will no longer cover the cost for individuals not currently taking them. The service will cover use for those already on them if their physicians consider continued use advisable.
"This is not a medical decision, it's a policy decision driven by the economics of U.K. nationalized health care," says William H. Thies, Ph.D., Alzheimer's Association vice president, medical and scientific affairs. "Current U.S. clinical consensus, reflected in guidelines issued by the American Academy of Neurology, is that it should be a standard of care for physicians to consider prescribing donepezil, rivastigmine or galantamine in mild to moderate Alzheimer's disease.
"Studies suggest that the average degree of benefit is small, but some individuals have a more significant response," Thies continues. "Until we have a way to determine who is more likely to respond to medications, the Alzheimer's Association believes families and diagnosed individuals should be presented with a clear and realistic discussion of the likely benefit and cost of treatment. Then they can decide along with their physicians whether use of these drugs makes sense for them. As with any drug, there should be ongoing evaluation of the response and rationale for continued treatment."
The three drugs covered in the American Academy of Neurology guidelines are all in a pharmaceutical class called cholinesterase inhibitors and work by temporarily increasing levels of a cell-to-cell messenger chemical that becomes deficient in the Alzheimer brain. There are currently no widely accepted professional U.S. guidelines addressing use of memantine (Namenda), approved by the U.S. Food and Drug Administration (FDA) late in 2003 for treatment of moderate to severe Alzheimer's. Memantine works by regulating levels of another messenger chemical also affected by Alzheimer's disease.
NICE does not have responsibility for licensing or approving drugs or medical devices and the agency's decision will not affect UK availability of the Alzheimer drugs. Responsibility for approval lies with the Medicines and Health Care Products Regulatory Agency.
For more information, please see:
- NICE draft guidance document
- American Academy of Neurology Practice Parameter for Management of Dementia. Published in the May 2001 Neurology
- Alzheimer's Association fact sheet on cholinesterase inhibitors (donepezil, rivastigmine and galantamine)
- Alzheimer's Association fact sheet on memantine