ALZHEIMER’S SOCIETY REPORT
Drugs for the treatment of Alzheimer's disease Submission to the National Institute for Clinical Excellence (Nice) June 2004
Alzheimer’s Society, Gordon House, 10 Greencoat Place, London SW1P1PH. Telephone 020 7306 0606. Fax 020 7306 0808 Email
[email protected] Website www.alzheimers.org.uk Registered Charity No. 296645. Company Limited by Guarantee Registered in England No. 2115499
ALZHEIMER’S SOCIETY REPORT
Drugs for the treatment of Alzheimer's disease
‘Aricept has been just marvellous, I had been going downhill in mental capacity for 18 months. I knew that it was very similar to my mother and at exactly the same age. I know how it developed with her, as I was involved with caring for her. I can see how lucky I have been – how Aricept has restored my life and given me time to reorganise and rethink.’ Q14645 71-YEAR-OLD WOMAN WITH ALZHEIMER’S DISEASE TAKING ARICEPT, RUTLAND
‘Within three days he’d calmed right down and by the end of four weeks he was a completely different person. No longer incontinent, could wash and dress himself with no help, no more hallucinations and joy of joys, was sleeping all night. Started doing jobs around the house and the care groups he attended couldn’t believe the change… I was able to cancel all of his respite care and we had a truly great six or seven months. He is now slipping back a bit, but as Alzheimer’s is a progressive disease I must expect that, at least he’s nowhere near as bad as last year and I hope to keep him at home for a good many more years.’ CARER FOR HER HUSBAND ON EBIXA, CUMBRIA
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Contents Executive summary 1
Introduction
2
Alzheimer’s Society
3
What is Alzheimer’s disease?
4
Good quality dementia care makes a difference
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Who cares?
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Alzheimer’s Society survey
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What evidence is there that drugs work for Alzheimer’s disease?
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Future Nice guidance: Alzheimer’s Society recommendations to ensure appropriate and equal access to drug treatments
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How much benefit does £1,000 per person per year buy?
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Barriers and prejudices
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Summary
Appendices I. Drug treatments for Alzheimer's disease: Aricept, Exelon, Reminyl and Ebixa (information sheet) II. What is Alzheimer’s disease? (information sheet) III. Alzheimer's Society survey on drugs for dementia IV. Results of questionnaire survey completed in January 2004 V. Guidelines for working with pharmaceutical companies VI. Declaration of interests
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Executive summary The Alzheimer's Society is the UK's leading care and research charity for people with dementia, their families and carers. The Alzheimer's Society has over 25,000 members and works through a network of over 250 branches and support groups. It provides information and support for people with any form of dementia and their carers through its publications, helplines, website and local network. It advises professionals, runs quality care services and campaigns for improved health and social care and greater public understanding of dementia. The Society funds an innovative programme of biomedical and social research in the areas of cause, cure and care. What is Alzheimer's disease? The term 'dementia' is used to describe the symptoms that occur when the brain is affected by specific diseases and conditions, including Alzheimer's disease. Dementia is progressive and no two cases of dementia are likely to be the same. In the early stages, the person is likely to experience loss of memory, confusion, mood and personality changes and communication problems. In the later stages of Alzheimer's disease, the person will have problems carrying out everyday tasks and will become increasingly dependent. People may fail to recognise even close family members, gradually lose their ability to walk, dress and feed themselves and may also become incontinent. Anticholinesterase drugs have been developed that can temporarily alleviate some of the symptoms of Alzheimer's disease in the early to middle stages. In 2002, a fourth drug – Ebixa – was launched in the UK. This drug can help people in the middle to later stages of dementia. These drugs do not cure Alzheimer's disease; they aim to stabilise some of the symptoms. Good quality dementia care makes a difference Drug treatments play an important role in enhancing a package of care for many people. However, good quality dementia care is important for people in all stages of the disease, whether or not they are benefiting from drug treatment. Unfortunately, the quality and availability of care varies hugely around the country.
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Who cares? Unpaid carers deliver most of the care to people with Alzheimer's disease in the UK. Most carers are partners/spouses and many are elderly and frail themselves. Carers of people with dementia experience greater strain, distress and higher levels of psychological morbidity than carers of other older people. Recent research shows the ability of the carer to cope is the most significant factor in the shift from home to institutional care. The Alzheimer's Society survey The Alzheimer's Society sent out a survey in November 2003 to its membership and to memory clinics. It sought the views and experiences of people with dementia and their carers on the anti-dementia drugs. Over 4,000 questionnaires were returned. Of these, 2,889 were from people who had experience of drug treatment for dementia. What evidence is there that the drugs work? A large body of published scientific data on the clinical effectiveness of all four anti-dementia drugs now exists. Cochrane reviews of all four drugs confirm efficacy. When asked, 'Taking everything into consideration, do you feel that the drug treatment you have received worked?', 73 per cent of survey respondents with Alzheimer's disease and with experience of anti-dementia drugs said ‘yes’. However, the drugs do not work for a significant minority of people with Alzheimer's disease. It is important to recognise that it is impossible to predict in advance who will derive benefit from the drugs. When asked to list up to five ways in which the treatment was helpful, people reported benefits in terms of happiness, awareness and confidence, rather than simple effects on memory or activities of daily living. Alzheimer's can make people feel scared, worthless and stupid. A drug that can give people confidence to continue everyday activities is extremely valuable to people with dementia. In the later stages, Ebixa can help people maintain basic skills such as feeding themselves and going to the toilet unaided. It can also help to maintain verbal communication and mobility. Maintaining these skills has a significant impact on the quality of life of both the person with Alzheimer's and their carer.
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Reporting rates of adverse effects are much lower than reporting rates of benefits. The most common side-effects (upper and lower gastrointestinal) are the well recognised, early and self-limiting symptoms associated with the cholinesterase inhibitors. When side-effects are unbearable, treatment is stopped. Future Nice guidance Nice guidance on the anticholinesterase treatments issued in January 2001 has had a positive impact on people with dementia and their carers. However, the application of the current guidelines has created a number of barriers to accessing the drugs. The Society sets out 18 recommendations in this submission, which should facilitate more appropriate access to drug treatment. How much benefit does £1,000 per year per person buy? The cost of dementia is high, both in terms of public and private resources. People affected by dementia also pay a high price in terms of quality of life. The costs of Alzheimer's disease are estimated to be between £7.06 billion and £14.93 billion. The NHS bears relatively little of the cost of this illness. Conventional pharmacoeconomics cannot be applied to drug therapies for dementia. Many of the benefits that a treatment may bring affect indirect costs through reduced carer burden and improvement in a person's quality of life. Quality Adjusted Life Years (QALYs) inherently discriminate against older people and thus raise particular problems for calculating the costs of dementia. With an illness such as dementia, how to measure the value of delaying symptoms or improving quality of life is one of the highest priorities. Barriers and prejudices Although Nice guidance has improved access to drugs, people with Alzheimer's continue to face unnecessary barriers to treatments, including ageism, postcode prescribing and people living in care homes being denied access to drugs. Summary The evidence provided by our survey demonstrates that these drug treatments can lead to an improved quality of life for many people with dementia and their carers. The Alzheimer's Society believes that drugs for dementia should be available through the NHS to all those who may benefit from them. 6 of 60
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Introduction
This Alzheimer's Society's submission to Nice includes the views of people with dementia as well as those of carers. Eight years ago, this would not have been possible. The introduction of drugs for Alzheimer's and their subsequent approval by Nice has enabled people affected to continue to communicate their views to others. It is no coincidence that the people who are able to tell us what it is like to have Alzheimer's most clearly and for the longest are those being treated with one of the drugs for Alzheimer's disease. Dementia is the major health and social care challenge of the 21st century. Alzheimer's disease is the most common cause of dementia. There is no known cure. However, the introduction of drugs for the treatment of Alzheimer's has delayed the onset of many symptoms and given thousands of people an improved quality of life. Scientific and consumer evidence suggests that while many people with Alzheimer’s disease may benefit from these treatments, there are many barriers to accessing treatment. The Society commissioned new research to find out people’s experiences of these treatments. Over 4,000 questionnaires were returned from people with dementia and their carers during December 2003 and January 2004. Of the questionnaires returned, 2,889 (71 per cent) said that they had experience of drug treatments for dementia; 2,672 of these (66 per cent) had tried Aricept, Exelon, Reminyl or Ebixa. Alleviating the distress caused by dementia has important economic, social and humanitarian implications. This paper outlines the important role of antidementia drugs in improving the quality of life, care and support for both the person with Alzheimer’s disease and their carers.
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Alzheimer’s Society
The Alzheimer’s Society is the UK’s leading care and research charity for people with all forms of dementia, their families and carers. Dementia affects over 750,000 people in the UK alone. The Alzheimer’s Society has over 25,000 members and works through a network of over 250 branches and support groups in England, Wales and Northern Ireland. We bring together people with dementia, carers, family and friends, health and social care professionals, researchers, scientists and politicians to work towards improving the lives of all concerned.
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The Alzheimer’s Society provides clear and accurate information on all forms of dementia, on services and benefits, and on caring, legal and financial matters.
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We provide a network of branches and support groups, special projects and telephone helplines.
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We fund research into dementia through our innovative Quality Research in Dementia (QRD) programme, involving people with dementia and their carers in setting research priorities in the areas of cause, cure and care.
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We support families in financial need.
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We run courses and conferences and produce high quality material for professionals and care service providers.
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We run quality day and home care services through our branches.
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We produce newsletters, booklets, reports, videos and audiotapes. Much of this information is available on the Society’s national website www.alzheimers.org.uk.
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We campaign for the needs and interests of people with dementia and their carers to be recognised in improved health and social care and for greater public awareness of dementia.
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We aim to involve people with dementia in all aspects of our work.
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As a member of Alzheimer Europe and Alzheimer’s Disease International, the Alzheimer’s Society contributes to worldwide efforts to tackle the international problem of dementia. As one of the leading organisations it supports the development of carers’ organisations in other countries.
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What is Alzheimer’s disease?
The term 'dementia' is used to describe the symptoms that occur when the brain is affected by specific diseases and conditions. These include Alzheimer's disease and stroke. Dementia is progressive, which means that the symptoms will gradually get worse. How quickly the disease progresses will depend on the individual. Symptoms of Alzheimer's disease vary between individuals. No two cases of dementia are likely to be the same. Progress of Alzheimer’s disease Typically, Alzheimer's disease begins with lapses of memory, difficulty finding the right words, and mood swings. As the disease progresses, there may be: Loss of memory People with dementia may forget names and places or forget their way home. ‘All those years I’ve known a name and now I can’t remember. I don’t know the names of some of my children – I have to look them up.’
Confusion People may become confused when handling money, driving a car or using a washing machine. ‘I was getting dressed one morning and I had put my shirt on the wrong way round. I did it the next day and my wife said that I should go to the doctor. He sent me for a scan – that was the start of my memory problems.’
Mood changes People with dementia may burst into tears for no apparent reason, or become convinced that someone is trying to harm them. Some of these changes result from the disease affecting parts of the brain that control emotion. People may also feel sad, frightened or angry about what is happening to them. ‘Things are changing in my life. I’ve started getting argumentative about subjects on the television or in the newspaper. I try to keep quiet when reading to myself, but I can’t. It seems to be a trait I’ve developed – I don’t like it very much.’
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Personality changes People may no longer seem to care about those around them. They may become irritable or apathetic. ‘My family picked up there was something wrong with me. I wanted to stay in the house. It wasn't like me. I'd always gone out – to the bowls, to the community centre. One day I went out with odd shoes on – I tried to hide it.’
Communication problems People with dementia may experience a decline in their ability to talk, read and write. In the later stages, they may be unable to speak or communicate. They may become withdrawn, either because of a loss of confidence or owing to communication problems. ‘I am a sailor at heart. I was always aboard ships. One day, looking at a log book, I found that I couldn’t understand what was on the page. I found this very frightening. Not being able to read anymore is a huge loss for me.’
Later stages of Alzheimer’s disease In the later stages of dementia the person affected will have problems carrying out everyday tasks and will become increasingly dependent on other people. People may: • Fail to recognise even close family members, or be unable to find their way around their own home. • Gradually lose their ability to walk, wash, dress and feed themselves. • Find it difficult to eat and, later, to swallow. • Lose control of their bladder; some people may also lose control of their bowels. • Adopt unsettled and unsettling behaviour, such as getting up in the middle of the night or walking away from home and becoming lost.
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What does it feel like to have Alzheimer's disease? Unless you have Alzheimer's disease, it is impossible to understand the experience fully. Experiencing the day-to-day symptoms can make people feel scared, worthless and stupid. It is a frightening disease with symptoms that are progressive and irreversible. The quotes that follow illustrate the types of feelings and emotions that people in the earlier stages of the illness may have. ‘This has hammered me. I felt as though my brain had blown. I don’t know the way to go. When I write, I realise my state of mind. I just throw it all down – it’s like confetti and I try to pick up all my pink pieces.’
It is more difficult to understand what it is like for people in the later stages of the disease. It is commonly assumed that a person with Alzheimer's disease has nothing to contribute and can no longer make any decisions for themselves. ‘They gave her food and drink she did not normally enjoy. Although she disliked sweet tea, she was always served tea with two sugars. They said she didn’t know the difference and wouldn’t remember she disliked sweetness.’
Traditionally, dementia has been dismissed as something that happens to people when they get old. It has been assumed that little can be done to improve quality of life for people in later stages of dementia. However, it is now recognised that people with Alzheimer’s are individuals with needs that can and should be met. Ensuring that treatment and care maximise quality of life should be the goal of all dementia care services. What causes dementia? Alzheimer's disease is the most common cause of dementia, affecting around 500,000 people in the UK. Alzheimer's disease is a physical disease affecting the brain. So far, no one single factor has been identified as a cause for Alzheimer's disease. It is likely that a combination of factors, including age, genetic inheritance, environmental factors, diet and overall general health, are responsible. During the course of the disease 'plaques' and 'tangles' develop in the structure of the brain, leading to the death of brain cells. People with Alzheimer's also have a shortage of some important chemicals in their brain. These chemicals are involved with the transmission of messages within the brain.
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Drug treatments for Alzheimer’s disease Drugs have been developed that can temporarily alleviate some of the symptoms of Alzheimer's disease in the early to middle stages. These drugs act in the brain to maintain supplies of an important chemical called acetylcholine. These drugs are: • • •
Aricept (donepezil) Exelon (rivastigmine) Reminyl (galantamine).
A fourth drug called Ebixa (memantine) was launched and licensed in the UK for the treatment of moderate to severe Alzheimer’s disease in 2002. Working in a different way to the other three drugs, Ebixa can help people in the middle to later stages of dementia. Pharmacologically, Ebixa is an uncompetitive glutamate NMDA receptor blocker. The drug is thought to work by blocking the action of the excitotoxic neurotransmitter, glutamate, found in excess in the brains of people with dementia. None of these drugs will cure Alzheimer's disease; they aim to stabilise some of the symptoms.
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Good quality dementia care makes a difference
The care received by people with Alzheimer's disease varies. However, it usually involves a mixture of community services and drug treatments. The introduction of drug treatments has brought about a significant change in the culture of dementia care. These drugs have highlighted the need for early diagnosis and the importance of assessing people’s needs at all stages of dementia. They have also encouraged the treatment or alleviation of symptoms, even in the late stages of Alzheimer’s disease. People with Alzheimer's disease and their carers require a broad range of services from social services and the NHS. These include services from people who deal with physical aspects of dementia, such as dieticians and continence advisers. Most of the state funded care received by someone with dementia is classed as social care and is therefore means tested. As the disease progresses, people usually require more intensive support and may eventually need to move to a care home. It is estimated that up to three-quarters of care home residents have a form of dementia. Access to a package of good quality care can make a significant difference to the quality of life of people with dementia and their carers. The package of care should encourage good physical health, support carers and enable the person with dementia to maximise their independence. Unfortunately, such packages appear to be rare. The Society often hears from people who have had to battle to receive any kind of support. The most recent Social Services Inspectorate report for England (2003) concluded that older people with mental health difficulties were often poorly served and that there were major gaps in provision.i The Society is hopeful that the planned Nice dementia guideline will encourage consistency in the accessibility and quality of services. Responses to the Society questionnaire demonstrate the heterogeneity of services received and how, in many cases, these services have to be paid for. Three hundred and seventy five respondents received none of the services listed; 307 of these respondents had experience of dementia drugs.
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Received service (% of total)1 Community psychiatric nurse
1842 (45%)
Had to pay (% of recipients) 9 (
