вторник, 12 апреля 2011 г.

Update on the NICE appraisal of Alzheimer's drugs, UK

The National Institute for Health and Clinical Excellence (NICE) has requested more evidence from pharmaceutical companies before publishing the final draft of its review of donepezil, rivastigmine, galantamine and memantine for the treatment Alzheimer's disease.


The Institute's Appraisal Committee met on 1 June to consider feedback from stakeholder organisations representing healthcare professionals, patients, carers and pharmaceutical companies - together with feedback from individual clinicians and the families, friends and carers of those with Alzheimer's disease - on the first draft consultation document. At this meeting the Committee agreed that, based on the evidence currently available, and having taken full account of the response to consultation, they could not change their original conclusion.


However, responses received during consultation suggest that the drugs may be particularly effective for certain groups of people. NICE has therefore asked the pharmaceutical companies involved in the appraisal to look for evidence to support this, in the data from their clinical trials.


Andrew Dillon, NICE Chief Executive and Executive Lead for this appraisal said: "We are acutely aware of our responsibility to people with Alzheimer's disease, their families and carers, to ensure that every effort is made to obtain all the available evidence on these drugs. 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."


This means that NICE has not issued new guidance to the NHS on the use of donepezil, rivastigmine, galantamine and memantine for the treatment of Alzheimer's disease. Until final guidance is issued the existing NICE guidance no. 19 (available at nice.uk/page.aspx?o=14400) continues to apply.


Andrew Dillon, continued, "While we look for this additional data, the drugs continue to be available and our existing, positive guidance, issued in 2001, remains in force. Responses to our request for further information will be considered by the Appraisal Committee in October 2005."

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