NICE calls for data to support Alzheimer’s drugs
Some patients with Alzheimer’s disease may respond to drugs
better than others |
The National Institute for Health and Clinical Excellence has called
for more data from the manufacturers of donepezil, rivastigmine, galantamine
and memantine before it publishes its final guidance on the use of these
medicines to treat Alzheimer’s disease.
Recommendations made by NICE in the first
draft of its guidance evoked
strong responses from pharmaceutical companies and patient groups who
criticised the suggestion that the drugs should not be made available
for use within the NHS in England and Wales.
Having considered their responses, NICE has not changed its conclusion.
However, it believes that the drugs may be particularly effective for
certain groups of patients and has asked the companies involved to look
for evidence to support this.
Andrew Dillon, NICE chief executive, said: “We need to make the
right decision, based on all the relevant evidence. We think there is
more data which could affect our decision and we are asking the drug
companies for access to it.”
The approach taken by NICE has been met with criticism from the pharmaceutical
industry.
In a statement issued on behalf of Eisai Ltd, manufacturer of Aricept
(donepezil), and Pfizer, Tony Elliott, professor in mental health at
Staffordshire University, said: “To call for a sub-group analysis
presents significant challenges and in my opinion is unrealistic, as
currently there is no reliable predictor to indicate which Alzheimer’s
patients will respond better to treatment than others.”
In a separate statement, issued on behalf of Shire Pharmaceuticals, manufacturer
of Reminyl (galantamine), Roger Bullock, consultant old age psychiatrist
at Victoria Hospital, Swindon, said: “In line with original guidance
from NICE, we review our patients after six months and stop treatment
if we feel that they are not responding. Taking this practice into account
demonstrates that these drugs are not only clinically effective, but
also cost-effective. All patients should be given the opportunity to
benefit from them.”
Until new guidance is issued, existing NICE recommendations (that endorse
use of donepezil,
rivastigmine [Exelon] and galantamine in Alzheimer’s
disease) continue to apply.
NICE is currently developing a clinical guideline on the management
of dementia. This guideline is expected to be published in February 2007. |
The
Pharmaceutical Journal
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