testimonials

"This decision essentially means there are no licensed and effective treatments routinely available for a vulnerable patient population where it is particularly needed. The overall NICE appeal outcome limits choice for all patients.”

Lundbeck, a Danish research-based company that finds new drugs for treatment of CNS disorders, including depression, schizophrenia, and Alzheimer’s disease comments on the NICE Appeal Decision:

Lundbeck is disappointed that the Appeal Committee for the National Institute for Health and Clinical Excellence (NICE) has decided not to recommend obligatory NHS funding for the routine prescription of Ebixa (memantine) in England and Wales for the treatment of moderately severe to severe Alzheimer's disease (AD) 2. However, the Appeal Committee did uphold Lundbeck's Appeal to amend their statement to acknowledge that they had not reviewed the moderate extension to Ebixa's indication 3. NICE guidance therefore does not apply to Ebixa for patients with the moderate stage of the disease, where evidence in clinical trials shows Ebixa delays clinical worsening that would otherwise be the normal course in AD4. Therefore, Ebixa is an NHS treatment option that can be initiated as early as moderate AD.

This guidance conflicts with the views of a large number of specialists who treat Alzheimer's disease. Indeed, the majority of them felt that Ebixa should be routinely available on the NHS, and would wish to continue to prescribe5. The Alzheimer's Society has been campaigning against this guidance, which it feels cruelly restricts access to Alzheimer's drugs. Individual Trusts can now decide locally if they will routinely fund Ebixa for moderately severe to severe AD. Moderately severe to severe patients already receiving treatment with Ebixa are not affected by this Guidance. Over a million people worldwide have experienced treatment with Ebixa; 7,500 UK patients per month have access to Ebixa on the NHS.

Commenting on the outcome of the appeal, Dr Roger Bullock, Director of Research at the Kingshill Research Centre in Swindon said, “The outcome of this appeal with particular reference to memantine is a significant setback in the successful management of moderately severe to severe Alzheimer's disease. This decision essentially means there are no licensed and effective treatments routinely available for a vulnerable patient population where it is particularly needed. The overall NICE appeal outcome limits choice for all patients.”

Denise Taylor, Senior Teacher Fellow from the Department of Pharmacy and Pharmacology at the University of Bath added, “Memantine is an effective treatment and to take this away from patients will have an impact on their quality of life and that of their carers. Memantine has kept patients out of nursing homes and enable them to stay longer in the community.”

Background

Clinical trials with Ebixa have shown significant benefits in all three main symptom categories (domains) of Alzheimer's disease: cognition, function and behaviour. Study results have also demonstrated that Ebixa is effective in reducing some of the core and most distressing symptoms of AD. Ebixa-treated patients experienced significant benefits in memory, language and the ability to perform daily activities 6-10.

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 3,12,13.

At the request of NICE, Lundbeck provided additional data from three studies, which detail the effects of Ebixa in a sub-population of patients with behavioural disturbances 3. It is therefore particularly disappointing that these results and their impact on the community of carers were not fully acknowledged by NICE. Furthermore, it is estimated that a large proportion of the total costs of AD is dedicated to the more severe AD population 11, and that behavioural disturbances are one of the main reasons for nursing home placement 12. Lundbeck's continued research will further support the comprehensive data set already presented 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 13.

1. Alzheimer's Society.
2. NICE Appeal Announcement.
3. Lundbeck Appeal post NICE FAD, Health Technology Appraisal, Alzhiemer's Disease - donepezil, rivastigmine, galantamine & memantine (review), May 26th 2006.
4. Wilkinson D. Prevention of the Worsening of Clinical Symptoms in Moderate to Severe. Alzheimer's Disease in Patients Treated with Memantine. Presented at the 9t International Geneva/Springfield Symposium on Advances in Alzheimer Therapy, 19th-22nd April 2006, Geneva, Switzerland.
5. Lundbeck survey carried out by TNS in May 2006 using a sample size of 100 dementia specialists.
6. Reisberg B, Doody RS, Stöffler A et al. Memantine in Moderate-to-Sever Alzheimer's Disease. New England Journal of Medicine 2003;384(14):1333-1341.
7. Reisberg B, Doody R, Stöffler 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.
8. 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.
9. 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.
10. Lundbeck. Data on file 2006.
11. Cacabelos R, Takeda M, Winblad B. The Glutamatergic System and Neurodegeneration in Dementia: Preventive Strategies in Alzheimer's Disease. Int J Geriatric Psychiatry 1999; 14: 3 - 47.
12. 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.
13. The Royal College of Psychiatrists.