NICE proposes to withdraw Alzheimer's drugs from NHS
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《英国医生杂志》
The drugs donepezil, rivastigmine, galantamine, and memantine should no longer be prescribed on the NHS to treat Alzheimer's disease, says new draft guidance from the National Institute for Clinical Excellence (NICE).
NICE, the NHS prescribing watchdog for England and Wales, has retracted its previous guidance"issued in 2001 and which said that these drugs should be prescribed for Alzheimer's disease—after reviewing the latest evidence on efficacy and cost effectiveness. Patients currently receiving any of the drugs, however, can continue to do so. Memantine will be available only as part of a clinical trial with strict outcome criteria.
Comments on the proposals are being accepted until 21 March, and final guidance is expected to come into force in July this year.
The NICE assessment group says that, although donepezil, rivastigmine, and galantamine (collectively known as anticholinesterase inhibitors) have proved gains in cognitive and global scales compared with placebo in people with mild to moderate Alzheimer's disease, there is "limited and largely inconclusive" evidence on outcomes that are important to patients and carers, such as quality of life and time to admission to a nursing home.
NICE considered a range of published and unpublished trials, as well as submissions from drug manufacturers and professional and support organisations, when developing its draft guidelines. However, it said that many of the randomised controlled trials it reviewed were of "mixed" quality. The group also suspected "selection bias, measurement bias and attrition bias in a number of the reviewed studies."
Its own cost effectiveness calculations put the group of drugs beyond the means of the NHS, it said. When it adjusted costs to take account of the benefits attributed to these drugs NICE estimated that donepezil, rivastigmine, and galantamine had a cost per quality adjusted life year gained of ￡48 000 ($92 000; 70 000), ￡32 000, and ￡38 000 respectively; the corresponding cost for memantine was between ￡37 000 and ￡53 000.
The NHS will spend an estimated ￡60m on anticholinesterase inhibitors this year and more than ￡70m in 2005-6, says NICE. If its proposed recommendations are adopted the NHS would make a saving of ￡15m in the first year, ￡45m in the second, and more than ￡60m in the third.
However, the proposals have been greeted with anger from professionals, patient groups, and drug manufacturers.
"Whilst these drugs do not provide a cure, or affect the underlying disease process, they can bring substantial benefit to many patients," said Professor Susan Benbow, of the Royal College of Psychiatrists. "On average, drugs for Alzheimer's disease delay the decline associated with the illness by six to nine months. This is a degree of benefit which... patients value."(Zosia Kmietowicz)
NICE, the NHS prescribing watchdog for England and Wales, has retracted its previous guidance"issued in 2001 and which said that these drugs should be prescribed for Alzheimer's disease—after reviewing the latest evidence on efficacy and cost effectiveness. Patients currently receiving any of the drugs, however, can continue to do so. Memantine will be available only as part of a clinical trial with strict outcome criteria.
Comments on the proposals are being accepted until 21 March, and final guidance is expected to come into force in July this year.
The NICE assessment group says that, although donepezil, rivastigmine, and galantamine (collectively known as anticholinesterase inhibitors) have proved gains in cognitive and global scales compared with placebo in people with mild to moderate Alzheimer's disease, there is "limited and largely inconclusive" evidence on outcomes that are important to patients and carers, such as quality of life and time to admission to a nursing home.
NICE considered a range of published and unpublished trials, as well as submissions from drug manufacturers and professional and support organisations, when developing its draft guidelines. However, it said that many of the randomised controlled trials it reviewed were of "mixed" quality. The group also suspected "selection bias, measurement bias and attrition bias in a number of the reviewed studies."
Its own cost effectiveness calculations put the group of drugs beyond the means of the NHS, it said. When it adjusted costs to take account of the benefits attributed to these drugs NICE estimated that donepezil, rivastigmine, and galantamine had a cost per quality adjusted life year gained of ￡48 000 ($92 000; 70 000), ￡32 000, and ￡38 000 respectively; the corresponding cost for memantine was between ￡37 000 and ￡53 000.
The NHS will spend an estimated ￡60m on anticholinesterase inhibitors this year and more than ￡70m in 2005-6, says NICE. If its proposed recommendations are adopted the NHS would make a saving of ￡15m in the first year, ￡45m in the second, and more than ￡60m in the third.
However, the proposals have been greeted with anger from professionals, patient groups, and drug manufacturers.
"Whilst these drugs do not provide a cure, or affect the underlying disease process, they can bring substantial benefit to many patients," said Professor Susan Benbow, of the Royal College of Psychiatrists. "On average, drugs for Alzheimer's disease delay the decline associated with the illness by six to nine months. This is a degree of benefit which... patients value."(Zosia Kmietowicz)