Landmark Ruling Comes Into Effect: Treatment now Available for People With Mild Alzheimer's at Time of Diagnosis

LONDON, March 23, 2011 /PRNewswire/ -- Alzheimer's patients in England and Wales can now be prescribed treatment when presenting with mild stages of the disease. New guidance from the National Institute for Health and Clinical Excellence (NICE) comes into effect today, marking a significant change to an earlier 2007 ruling which restricted access to medication for patients with moderate disease only.[1]*

The guidance recommends three Alzheimer's disease medications belonging to a class of drugs known as acetylcholinesterase (AChE) inhibitors, including Aricept(R) (donepezil), as possible options for managing mild to moderate Alzheimer's disease.

"This is a milestone for people with Alzheimer's disease, their families, carers and society as the new ruling means that crucial treatment can be given earlier thereby helping to reduce the impact of the disease at a much earlier stage", says Dr Craig Ritchie from Department of Psychological Medicine, Imperial College London, Honorary Consultant and R&D Director, West London Mental Health Trust.

The new guidance supports the Department of Health's National Dementia Strategy[2] which encourages the active management of Alzheimer's disease to minimise the burden of the condition on patients, their carers and society. In addition, the need for greater access to dementia-specific treatments is in line with the recent Alzheimer's Disease International report which calls for governments to make dementia a higher health priority, to help tackle the huge burden of the disease.[3]

As a result of NICE's decision, GPs have an option for early intervention; "This NICE guidance is a call to action for GPs to talk with all patients who were previously denied treatment at the early stages of this devastating disease. Early treatment at the first signs of the disease, can work towards significantly improving their quality of life" added Dr Sarah Jarvis, GP, Richford Gate Medical Practice.

Nick Burgin, Managing Director UK, Eisai Limited(R) said: "We are delighted that patients with early disease will now finally have an opportunity to receive Alzheimer's treatments such as Aricept(R). Greater awareness is needed amongst GPs, patients and carers of the early treatment options now available to them which could lead to better outcomes for people with Alzheimer's."

*Additional information on the NICE guidance[1]

1.1 The three acetylcholinesterase (AChE) inhibitors (donepezil, galantamine and rivastigmine) are recommended as options for managing mild to moderate Alzheimer's disease under all of the conditions specified in 1.3 and 1.4.

1.2 Memantine is recommended as an option for managing Alzheimer's disease for people with: moderate Alzheimer's disease who are intolerant of or have a contraindication to AChE inhibitors or severe Alzheimer's disease.

1.3 Treatment should be under the conditions specified in 1.3.

- Only specialists in the care of patients with dementia (that is, psychiatrists including those specialising in learning disability, neurologists, and physicians specialising in the care of older people) should initiate treatment. Carers' views on the patient's condition at baseline should be sought.

- Treatment should be continued only when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms.

- Patients who continue on treatment should be reviewed regularly using cognitive, global, functional and behavioural assessment. Treatment should be reviewed by an appropriate specialist team, unless there are locally agreed protocols for shared care. Carers' views on the patient's condition at follow-up should be sought.

1.4 If prescribing an AChE inhibitor (donepezil, galantamine or rivastigmine), treatment should normally be started with the drug with the lowest acquisition cost (taking into account required daily dose and the price per dose once shared care has started). However, an alternative AChE inhibitor could be prescribed if it is considered appropriate when taking into account adverse event profile, expectations about adherence, medical comorbidity, possibility of drug interactions and dosing profiles.

For the full guidance, please visit: http://guidance.nice.org.uk/

Currently, there are around 820,000 people living with Alzheimer's and other dementias in the UK,[4] including an estimated 575,000 sufferers in England and 37,000 in Wales.[5] Alzheimer's disease is the most common form of dementia, affecting 62% of dementia patients in the UK.[5] This irreversible, progressive brain disorder gradually destroys memory, reasoning and thinking skills, and may eventually leave patients unable to carry out even the simplest tasks.[6] Alzheimer's disease has impacts in many ways including physical, mental, nursing, medical and social impacts.[1] Despite its burden, Alzheimer's remains a relatively overlooked disease. Just 2.5% of the government's medical research budget is devoted to dementia; in contrast a quarter is allocated to cancer research.[7]

About Eisai

Eisai is one of the worlds leading research-based pharmaceutical companies that has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).

Eisai concentrates its research activities in three key areas:

- Integrative Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression

- Integrative Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea

- Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, we employ more than 11,000 people worldwide.

Pfizer: Working Together for a Healthier World(TM)

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. In the UK, Pfizer has its business headquarters in Surrey and is the major supplier of medicines to the NHS. To learn more about our commitments, please visit us at http://www.pfizer.co.uk

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[1] National Institute for Health and Clinical Excellence, NICE Technology Appraisal guidance 111. Available at: http://guidance.nice.org.uk/

[2] NHS National Dementia Strategy. Available at: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_094052.pdf. Last accessed Sept 2010

[3] World Alzheimer Report 2010. Available at: http://www.alz.co.uk/research/files/WorldAlzheimerReport2010ExecutiveSummary.pdf. Last accessed Sept 2010

[4] Alzheimer's Research Trust -Dementia 2010. Available at: http://www.dementia2010.org/reports/Dementia2010Full.pdf. Last accessed Jan 2011

[5] Alzheimer Society. Available at: http://alzheimers.org.uk Last accessed Jan 2011

[6] National Institute on Aging (NIA). Alzheimer's Disease Factsheet. NIH Publication No 08-6423. Reprinted February 2010

[7] Alzheimer's Research Trust. Available at: http://www.alzheimers-research.org.uk/info/statistics/ Last accessed Jan 2011

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