NICE appraisal of Alzheimer’s drugs may be target of judicial
review
Will & Deni McIntyre/Science Photo Library
Patients with early Alzheimer's disease do not qualify for
treatment |
Manufacturers opposed to the decision by the National Institute for Health and Clinical Excellence's to restrict patient access to certain Alzheimer's disease drugs may seek a judicial review into the thinking behind the institute's dementia
guideline and a technology
appraisal released this week.
In the technology appraisal, NICE restricts the use of acetylcholinesterase
inhibitors donepezil, galantamine and rivastigmine to patients with moderate
Alzheimer’s disease, and memantine for use only as part
of well designed clinical studies (PJ, 14 October, p442). The same recommendations
are incorporated into NICE’s guideline “Supporting people
with dementia and their carers in health and social care”, developed
in conjunction with the Social Care Institute for Excellence.
Eisai and Pfizer, which together market Aricept (donepezil), are expected
to request a judicial review of the computer model used by NICE to assess
the cost-effectiveness of the drugs. This would be the first time that
NICE’s work has been legally challenged at this level. Shire Pharmaceuticals,
makers of Reminyl (galantamine), has supported the move.
According to Eisai, the company had
written to NICE calling for the institute to delay its guidance and provide
a working
version of the cost-effectiveness model for
independent evaluation. However, the institute has since released its
technology appraisal on the medicines as well as the dementia guideline.
NICE has a fortnight to respond to the correspondence, after which Eisai
can present its case to the High Court. If the judge sees that there
is a case it will proceed to a judicial review, a spokesman for Eisai
told The Journal.
Andrew Dillon, NICE chief executive, speaking at the guideline’s
launch, said that NICE has restricted use of acetylcholinesterase inhibitors
to patients who will obtain the best response — those with moderate
Alzheimer’s disease. The agents do not prevent newly diagnosed
patients from progressing to the later, more severe forms of the disease,
he said. He added that the dementia guideline offers more than just the
appraisal guidance on the use of drugs for people with dementia and demonstrates “the
real importance of health and social care professionals working closely
to drive forward improved standards of care”.
CPD (Understanding
Alzheimer’s disease) p643
Guideline seems to be based on health economics
David Taylor, chief pharmacist, South London and Maudsley NHS
Trust, told The Journal that the NICE recommendations seem to have
been made largely on the basis of results generated by health economic
modelling and may signal a new hard-line, more abstract approach
to guidance development.
“The calculations indicate that the drugs in question are most cost-effective
in moderately severe Alzheimer’s disease. I suppose this
is a valid approach in a cash-strapped health service, but it makes
for rather bizarre advice: patients will be forced to wait until
they become ill enough to receive treatment and will then have
treatment removed when they later become too severely ill,” he
said. “This guidance further blurs the boundary between regulatory
authorities and NICE, since it effectively and formally restricts
the use of licensed drugs to a greater extent than their licence
dictates.” |
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