Donepezil, galantamine and rivastigmine (review) and memantine for the treatment of Alzheimer's disease (amended 2007)
The above amended NICE appraisal was published on Friday 7 September in accordance with the outcome of the judicial review and following consultation by NICE with Eisai Limited, Shire Pharmaceuticals Limited and The Alzheimer’s Society.
Web reference for appraisal and other related documents: http://www.nice.org.uk/guidance/TA111
NHSScotland should note that:
1. The email sent to NHSScotland on 22 November 2006 outlining the applicability of the NICE appraisal to Scotland still applies. However NHSScotland should be aware of the amended NICE appraisal.
2. The court in England ruled in the judicial review of this appraisal on 10 August 2007 and found in NICE’s favour in five out of six points. The judge asked NICE to amend the appraisal to make clear the intention that people with learning disabilities and people whose first language is not English should have equal access to the drugs in the moderate stage of Alzheimer’s disease.
Also in accordance with the ruling, NICE consulted with the claimant in the judicial review, Eisai Limited and the two interested parties, the Alzheimer’s Society and Shire Pharmaceuticals Limited, on the detail of the amendment. No other parties were involved in this consultation.
The judge asked NICE to do all this within 28 days of her judgement and to ensure that those affected by the appraisal are aware of the action NICE are taking and of the amendment once it has been made.
3. Amended Appraisal - The substantive amendment is the inclusion of the new text at paragraph 1.2 (noted below). A small concomitant change has been made to one paragraph in the body of the appraisal:
“When using the MMSE to diagnose moderate Alzheimer’s disease, clinicians should be mindful of the need to secure equality of access to treatment for patients from different ethnic groups (in particular those from different cultural backgrounds) and patients with disabilities.
1.2 In determining whether a patient has Alzheimer’s disease of moderate severity for the purposes of section 1.1 above, healthcare professionals should not rely, or rely solely, upon the patient’s MMSE score in circumstances where it would be inappropriate to do so. These are:
- where the MMSE is not, or is not by itself, a clinically appropriate tool for assessing the severity of that patient’s dementia because of the patient's learning or other disabilities (for example, sensory impairments) or linguistic or other communication difficulties
or- where it is not possible to apply the MMSE in a language in which the patient is sufficiently fluent for it to be an appropriate tool for assessing the severity of dementia, or there are similarly exceptional reasons why use of the MMSE, or use of the MMSE by itself, would be an inappropriate tool for assessing the severity of dementia in that individual patient’s case.
In such cases healthcare professionals should determine whether the patient has Alzheimer’s disease of moderate severity by making use of another appropriate method of assessment. For the avoidance of any doubt, the acetylcholinesterase inhibitors are recommended as options in the management of people assessed on this basis as having Alzheimer’s disease of moderate severity.
The same approach should apply in determining for the purposes of section 1.1 above, and in the context of a decision whether to continue the use of the drug, whether the severity of the patient’s dementia has increased to a level which in the general population of Alzheimer’s disease patients would be marked by an MMSE score below 10 points.”
4. Copies of the NICE appraisal can be downloaded from http://www.nice.org.uk. Also on the website are tools (a costing template and audit criteria) that NICE has developed to help organisations to implement this appraisal. Finally, an easy to read summary of the appraisal, called "understanding NICE guidance" is published on the NICE website to provide information for patients and the public.
5. Whilst this email alert is distributed widely in NHSScotland, I would appreciate if Medical Directors could forward this email to relevant health professionals in their Board.
6. Hard copies of the NICE appraisals are available from NHS Quality Improvement Scotland (contact Shonagh Buchanan, tel 0141 225 6993 or email shonagh.buchanan@nhs.net)