The National Institute for Health and Clinical Excellence (NICE) has today jointly published its guidance on the use of drugs to treat Alzheimer's disease (AD) and the clinical guideline on the management of all types of dementia, including AD, jointly with the Social Care Institute for Excellence. Lundbeck is disappointed by today's guidance on the use of drugs to treat AD where NICE has recommended Ebixa (memantine) only "as part of clinical studies for people with moderately-severe to severe AD(2)" in England and Wales. This means that Ebixa will not receive obligatory NHS funding for its routine prescription and will leave inequity of access to a licensed NHS treatment for UK's 309,000(3) advanced AD patients. NICE guidance didn't take account of the recent indication for the use of Ebixa in moderate patients, therefore it is still freely available to be initiated as an NHS treatment for moderate Alzheimer's disease.
This guidance conflicts with the views of a large number of specialists who treat AD. In its recent joint position statement, the Royal College of Psychiatrists and the British Geriatrics Society argue that there are compelling reasons why doctors should continue to be allowed to prescribe Ebixa(1). The reasons included that Ebixa improve outcomes for people with AD, reduces caregiver time, lead to more legitimate prescribing, reduce the costs of alternative medication, and reduce the need for specialist and continuing care(1).
Professor Roy Jones, Director of the Research Institute for the Care of the Elderly in Bath, said, "Ebixa has shown significant benefits in moderate to severe Alzheimer's disease. For example, one study has shown that Ebixa saves carers on average one and a half hours per day with benefits for the patients who are better able to feed themselves and are less agitated."
The British Association for Psychopharmacology (BAP) guidelines(13) and the European Federation of Neurological Societies (EFNS) guidelines(14) reinforces the efficacy of Ebixa in the treatment of moderate to severe AD either on its own or when added to a cholinesterase inhibitor (4,5).
Ebixa remains available in the UK on the NHS drug list for prescribing by clinicians in the UK. Individual Trusts can now decide locally if they will routinely fund Ebixa for new patients diagnosed with moderately severe to severe AD. Moderately severe to severe patients already receiving treatment with Ebixa are not affected by this guidance.
The clinical evidence for Ebixa:
Ebixa is approved in the UK for the treatment of patients with moderate to severe AD(6) and is the only anti-dementia drug with a licence for severe dementia. NICE did not recommended Ebixa in their guidance on the basis that the evidence provided showed that the drug did not make enough of a difference for AD patients. However, its efficacy has been established in all three main symptom categories of AD: cognition, function and behaviour. Large scale clinical trials have also demonstrated that Ebixa is effective in reducing some of the core and more distressing symptoms of AD. Ebixa treated patients experienced significant benefits in memory, language and the ability to perform daily activities(7-11).
In a six month trial, Ebixa has proven effective in delaying the emergence of, and significantly reducing levels of agitation/aggression in patients with AD, a benefit considered valuable amongst AD treatments(12,13,14).
Lundbeck's continued research will further support the comprehensive data set already presented to NICE and has the support of the expert community, many of whom feel that there is an inequity in the way that Ebixa has been evaluated(14).
References
1. Implementation of the NICE guidance on donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease: Position statement by the Royal College of Psychiatrists Faculty of Old Age Psychiatry, Royal College of Psychiatrists Faculty of the Psychiatry of Learning Disability, and the British Geriatrics Society. 16 October 2006.
2. National Institute for Health and Clinical Excellence Press Release 11 October 2006.
3. Alzheimer's Society.
4. Clinical practice with anti-dementia drugs. Journal of Psychopharmacology 20(6) (2006) 732-755.
5. European Handbook of Neurological Management: Official EFNS guidelines - 1st ed. Eds. Hughes R, Brainin M, Gilhus NE. Blackwell Publishing, Oxford; 2006.
6. Ebixa (memantine) Abbreviated Product information, May 2006.
7. Reisberg B, Doody RS, Stoffler A et al. Memantine in Moderate-to-Severe Alzheimer's disease. New England Journal of Medicine 2003;384(14):1333-1341.
8. Reisberg B, Doody R, Stoffler A et al. A 24-Week Open-Label Extension Study of Memantine in Moderate to Severe Alzheimer Disease. Archives of Neurology, 2006;63:1-6.
9. Schmitt FA, van Dyck C, Feldman H et al. Efficacy of memantine for cognitive deficits of mild to severe Alzheimer's disease. Poster presented at AAGP 2005.
10. Schmitt FA, Cragar D, Ashford JW et al. Measuring cognition in advanced Alzheimer's disease for clinical trials. J Neural Transm 2002;62:135-48.
11. Lundbeck. Data on file 2006.
12. Lundbeck Appeal post NICE FAD, Health Technology Appraisal, Alzhiemer's Disease - donepezil, rivastigmine, galantamine & memantine (review), May 26th 2006.
13. Gauthier S, Wirth Y, Mobius HJ. Effects of memantine on behavioural symptoms in Alzheimer's disease patients: an analysis of the Neuropsychiatric Inventory (NPI) data of two randomised, controlled studies. Int J of Geriatr Psychiatry 2005; 20: 459-464.
14. Position statement by the Royal College of Psychiatrists Faculty of Old Age Psychiatry, Royal College of Psychiatrists Faculty of the Psychiatry of Learning Disability, and the British Geriatrics Society, NICE and prescribing of cholinesterase inhibitors and memantine for the treatment of Alzheimer's Disease (Oct 2006) Click here to download the document
Source:
Lundbeck Ltd
Lundbeck House
Caldecotte Lake Business Park
Caldecotte
Milton Keynes
MK7 8LG, UK
For further information please visit:
Lundbeck Ltd
Комментариев нет:
Отправить комментарий