The National Institute for Health and Clinical Excellence (NICE) has published draft guidance that makes substantial revisions to recommendations for the treatment of Alzheimer's disease (AD). The new draft guidance for England and Wales indicates that Ebixa® (memantine), manufactured by Lundbeck, may be recommended for the first time for use as treatment for moderate AD (for people who are intolerant of or where acetylcholinesterase (AChE) inhibitors are contraindicated) and as the only first line treatment for severe AD. [i] In addition, data showing that Ebixa can improve symptoms of agitation, aggression and psychosis and may reduce the need for antipsychotic prescribing in people with moderate to severe AD1,[ii],[iii] were considered and accepted by the NICE Appraisal Committee.

Stephen Turley, Managing Director at Lundbeck UK welcomed the revised NICE draft guidance, saying: "This is very good news for people with AD and those closest to them. Under the new proposed recommendations, those with severe AD and some people with moderate AD will now have the opportunity to benefit from Ebixa's proven efficacy. The review also acknowledged that Ebixa may have the potential to reduce the need for harmful antipsychotics in people with distressing behavioural symptoms. We look forward to this guidance being finalised as soon as possible."

The issue of antipsychotic prescribing - or 'chemical restraint' - in people with dementia was initially highlighted by several government and patient bodies in 2009. This subsequently led the Government to commission a report to specifically address the management of people with dementia using antipsychotic medication in nursing and care homes and other settings. The report, Professor Sube Banerjee, found that up to 140,000 people with dementia may be inappropriately prescribed antipsychotic drugs and that an estimated additional 1,800 die per year as a result of inappropriate prescribing of antipsychotic medication. [iv] In response to the Banerjee report, the Government set a target to reduce this figure by up to 66% over a 36-month period beginning in January 2010.2

Last month, Paul Burstow MP, Minister of State at the Department of Health developed a report entitled: 'Quality outcomes for people with dementia: building on the work of the National Dementia Strategy'[v] which, as one of its four key priority objectives, addresses reducing the use of antipsychotics in people with dementia. Together, Burstow's report and the new draft recommendations provide clinicians with clear and practical guidance on treating people with AD as well as addressing the target set by the Government in 2009.

Peter Passmore, Professor of Ageing and Geriatric Medicine, Queen's University Belfast, said: "If the guidance is finalised as drafted, carers and clinicians will have a new treatment option for the management of moderate to severe AD which may also help them manage distressing behavioural symptoms without reverting to the unlicensed use of antipsychotic medication. For carers, coping with the distressing behavioural symptoms of AD is one of the most upsetting parts of looking after someone with this disease. It is now vital that Mr Burstow's key priority objectives are implemented on a local and national level and the draft NICE recommendations are finalised by the Appraisal Committee as soon as possible and to ensure people with dementia receive the treatment they deserve."

Also in this draft guidance, NICE is proposing to broaden the use of AChE inhibitors - donepezil HCL, rivastigmine, and galantamine to treat mild to moderate AD.1

AD is the most common form of the devastating illness, dementia, which currently affects approximately 820,000 people in the UK.3

About Ebixa

- Ebixa is licensed for the treatment of moderate to severe Alzheimer's disease[vi]

- Ebixa is a voltage dependent, moderate affinity uncompetitive NMDA-receptor antagonist, with a mechanism of action that targets glutamatergic signalling in the brain6

- Ebixa can improve symptoms of agitation, aggression and psychosis in patients with moderate to severe Alzheimer's disease[vii] and may reduce the need for psychotropic prescribing in these patients[viii]

- Data on the use of Ebixa in the agitation/aggression and/or psychotic symptom (APS) subgroup was specifically submitted to NICE for this re-review

- Ebixa is easy to administer, and can be taken with or without food, either as tablets or oral solution. The recommended maintenance dose of Ebixa is 20mg/day6

- Ebixa is the most recently available anti-Alzheimer's disease drug to gain marketing authorisation in the UK and was launched in October 2002. [ix] It is not routinely available as an NHS treatment[x]

About Dementia

- More than 820,000 people are affected by dementia in the UK3

- This figure is set to rise to more than 1,000,000 by 2025[xi]

- One in three older people in the UK, over the age of 65, dies with dementia3

- More than 60% of all care home residents in the UK, aged over 65, have a form of dementia3

- More than 15,000 people have early-onset dementia (under the age of 65)4

- More than 11,500 people from black and minority ethnic groups in the UK are affected by dementia11

- Dementia costs the UK £17 billion per annum[xii]

- Carers of people with dementia save the UK around £6 billion per annum11


[i] NICE draft guidance published here.

[ii] Government response to Professor Sube Banerjee's report on the prescribing of anti-psychotic drugs to people with dementia: 12 November 2009. Available here. Accessed August 2010.

[iii] Alzheimer's Research Trust website. Accessed August 2010

[iv] The use of antipsychotic medicine for people with dementia; time for action. A report for the Minister of State for Care Services by Professor Sube Banerjee. Available here Accessed September 2010.

[v] Quality outcomes for people with dementia: building on the work of the National Dementia Strategy, Paul Burstow MP, Care Service Minister. Published on 28th September 2010 See here

[vi] Ebixa, Summary of Product Characteristics. Available here.Accessed August 2010

[vii] Gauthier S, et al. Improvement in behavioural symptoms in patients with moderate to severe Alzheimer's disease by memantine; a pooled data analysis. International Journal of Geriatric Psychiatry 2008:23;527-545

[viii] Fillit, H et al. Memantine discontinuation in nursing home residents with AD is associated with increased psychotropic drug use and decreased weight. 10th International Hong Kong/Springfield Pan-Asian Symposium on Advances in Alzheimer Therapy. Hong Kong 2008 (poster)

[ix] EMEA European Public Assessment Report, 2009. Available here.

[x] NICE Technology Appraisal 111, Donepezil, galantamine, rivastigmine (review) and memantine for the treatment of Alzheimer's disease (amended), Issued: November 2006 (amended September 2007, August 2009). Accessed August 2010: here.

[xi] The Alzheimer's Society website: see here. Accessed August 2010

[xii] Living well with dementia: A National Dementia Strategy, Department of Health, February 2009. Accessed August 2010. Website: see here.


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