NICE revises decision on Alzheimer's drugs

The National Institute for Health and Clinical Excellence (NICE) has again delayed its final decision on the only licensed drug treatments for people with Alzheimer's disease. Instead, it has revised its position and produced new draft guidance for public consultation. In this latest draft guidance, NICE rejects calls for Ebixa, the only drug treatment for people in the later stages of Alzheimer's disease to be available on the NHS and in a double blow recommends that anti cholinesterase treatments also be withheld from people in the mild stages of the disease. These proposals are based on the cost effectiveness rather than clinical effectiveness of the drug treatments.

Neil Hunt, of the Action on Alzheimer's Drugs alliance, representing over thirty charitable and professional organisations reacted to the decision,

'We are relieved that NICE has withdrawn its plan to place a blanket ban on the only drug treatments for people with Alzheimer's disease. We welcome the fact that NICE has acknowledged the effectiveness of Alzheimer's drug treatments and the vital role they have to play in dementia care. However, the new draft guidance that NICE has produced still raises serious ethical and practical concerns about the availability of drug treatments for people with Alzheimer's disease. We will be highlighting these concerns during this consultation process. Unfortunately, the agonising wait for people with dementia and their carers goes on.

The new draft guidance places severe restrictions on access to drugs for people with Alzheimer's disease. We know that vulnerable people in the later stages of Alzheimer's benefit enormously from Ebixa. If this guidance is not changed, NICE will be withholding the only licensed drug proven to help them and increasing the likelihood that they will be prescribed unlicensed sedatives instead. This is simply unacceptable.

NICE acknowledges that the anti cholinesterase drug treatments work for people in all stages of dementia yet it proposes to withhold them from people in the early stages. It recommends that people be denied a drug treatment that may help them until they have declined sufficiently for that treatment to represent good value for money. This is completely unethical. People with dementia and their carers value the benefits that the drug treatments bring in the early stages of the disease. For what other condition would you wait until people decline so much that they can no longer look after themselves before giving them treatment? Especially when this treatment costs just £2.50 a day.'

Dr David Wilkinson, a leading old age psychiatrist, and member of the alliance adds:

'Whilst it is a relief for people with dementia, their carers and health professionals that NICE has changed its initial recommendation, its new draft guidance still has serious flaws. If approved, professionals will be in the impossible situation of withholding beneficial treatments from people with dementia because they are not ill enough. Drug treatments that work must be available to those who need them, and clinicians should be able to use their professional judgment to decide when to prescribe them.

Members of the alliance have spent many years promoting the importance of people with Alzheimer's disease getting an early diagnosis, so that they can access care and support. If this draft decision is not changed it will clearly have a detrimental impact on their diagnosis and care.

There was an unprecedented public response to NICE's initial consultation last March, demonstrating the strength of feeling across the country that people with Alzheimer's disease should have access to drug treatments that are proven to work. We hope that NICE will listen again to the views of professionals, people with dementia and their carers and ensure that people are not denied effective drug treatments because of cost.'

Diana Barnes, a person with Alzheimer's disease, says:

'When I first started to take a drug treatment for Alzheimer's disease it was like a fog in my head had been lifted. I still have good days and bad days, but the drugs have made a real difference. I know the drugs have improved my quality of life. It seems madness to take away things that are helping people like me to live as normally as possible. They talk about money, but these drugs only cost £2.50 a day.'

For more information, contact the Alzheimer's Society press office.

Notes for editors

• Interviews with people with dementia and their carers available on request.
• The National Institute for Clinical Excellence (NICE), the government body which produces guidance on which drug treatments should be funded by the NHS, is carrying out an appraisal of the four drug treatments currently licensed for Alzheimer's disease (Aricept, Exelon, Reminyl and Ebixa). NICE issued a draft decision for consultation in March 2005, that proposed none of the four treatments should be funded by the NHS. It acknowledged that the drugs were clinically effective, but stated that they were not cost effective. There was an unprecedented response to this guidance, with nearly 8,000 people with dementia, carers and professionals writing to express their outrage. NICE considered this response and in July asked the pharmaceutical companies for more data. It has now issued a revised draft decision for consultation. The consultation will end on 13th February 2006. The NICE committee will meet on 27 April 2006 to discuss the response to its second draft decision and to come to a final decision. This will be announced at some point after that meeting date.
• People currently on the drug treatments will continue to receive them.
• The Alzheimer's Society is the UK's leading care and research charity for people with dementia and their carers.
• There are approximately 381,920 people have Alzheimer's disease in England and Wales. Approximately 72,565 people would be in the mild stages of dementia and 309,355 people are in the moderate to severe stages.
• The Action on Alzheimer's Drugs alliance to campaign for fair access to Alzheimer's drug treatments. It launched the hands off dementia drugs campaign. Members of the Action on Alzheimer's Drugs alliance include:
• Neil Hunt is chief executive of the Alzheimer's Society. Dr David Wilkinson is a spokesperson for the Royal College of Psychiatrists.
• Over 750,000 people in the UK have dementia. More than half have Alzheimer's disease.
• Dementia affects one in 20 people over the age of 65 and one in five over the age of 80.
• There are 18,500 people in the UK under the age of 65 with dementia.
• For information and advice on Alzheimer's disease or other forms of dementia call the Alzheimer's Society national helpline on 0845 300 0336.
• Our website address is: http://www.alzheimers.org.uk/.