press release
Alzheimer's drugs policy: NICE policy upheld
16 August 2007
Campaigners have been unsuccessful in their High Court Challenge
to secure NHS funding of anti-dementia drugs for early stage
sufferers of Alzheimer's disease.
In the first case of its kind in the UK, Eisai
(the Japanese pharmaceutical firm) and Pfizer (the UK distributor),
with the support of the Alzheimer's Society, sought judicial review
of a National Insititute of Clinical Excellence
(NICE) decision over funding of 3 drugs used to treat
Alzheimer's disease.
Mikaler Cutts, health law expert at Browne
Jacobson, points out that the drugs in question – donepezil,
rivastigine and galantamine – were recommended as standard
treatment in NICE guidance published in 2001.
However, following further research and
numerous appeals, later guidance - published by NICE in 2006 -
indicated that the drugs should only be prescribed to patients with
moderate stage disease.
The Alzheimer's Society argued that treating
people at an earlier stage can slow the progress of this
devastating disease. However, NICE argued that the drugs – costing
about £2.50 per patient per day – did not make enough difference to
patients with early stage disease to be considered
cost-effective.
The High Court rejected claims that NICE
failed to properly assess the impact of the drugs on the quality of
life of carers as well as sufferers, and that the calculations of
the cost of long-term care used in their analysis were too low.
[does this mean long-term treatment with the drugs in question? Or
residential care of patients without the drug?] Two claims of
irrationality and procedural unfairness were also dismissed.
Campaigners were successful on one count: that
the tests used to assess Alzheimer's are discriminatory against
patients with learning difficulties or those for whom English is
not their first language.
The judge ordered that guidance is amended to
“ensure compliance with NICE's duties and obligations under
anti-discrimination legislation". Andrew Dillon, Chief Executive of
NICE, has already confirmed that the guidance will be
rewritten.
The upshot is that, for the moment at least,
the drugs will remain unavailable on the NHS for patients with
early stage disease. The Alzheimer's Society is preparing a
full response, and is understood to be considering an appeal.
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