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Sandra Gidley (Romsey) (LD): I am grateful to have the opportunity to raise this subject with the Minister, although I am slightly disappointed that the Under-Secretary of State for Health, the hon. Member for South Thanet (Dr. Ladyman), who I was told would respond and who made pronouncements in the press on the subject over the weekend, is not here to answer questions. However, I am sure that the Minister is a more than adequate substitute.
The request has been made simply because of the widespread consternation about the recent revised guidance from the National Institute for Clinical Excellence on the treatment of Alzheimer's. I raise that subject because I have been bombarded with letters from constituents and local health professionals. Some 52,000 people in the UK who currently benefit from these drugs are extremely concerned about the future availability of their treatments. Indeed, there is a lobby of Parliament today on the subject.
The reaction that I have received so far is that the decision by NICE smacks of ageism and that the mechanism for calculating cost-effectiveness is deeply flawed. As with most things, it is useful to take events in a logical sequence, so I want to start by reminding the Minister of the guidance produced by NICE in 2001. Technology appraisal guidance 19 dealt with the use of donepezil, rivastigmine and galantamine for the treatment of Alzheimer's. At that stage, NICE said:
"The three drugs . . . should be made available in the NHS as one component of the management of those people with mild and moderate Alzheimer's disease . . . as long as the patients conformed to certain criteria."
Other conditions were laid down at the time and they included assessment and diagnosis in specialist clinics. Only specialists could initiate treatment, the carer's view of the condition should be sought, patients should be reassessed two to four months after reaching the maintenance dose of the drug and the drug should generally be continued only if there had been some improvement. Guidelines also covered when the drug should be discontinued.
No one appeared to have any quarrel with that. It seemed that NICE came up with a system that should ensure that those in need received the drugs, which were not prescribed unnecessarily if there was no proven benefit. NICE deemed that the drugs were effective but acknowledged that they did not work for everyone. When it came to cost-effectiveness, NICE acknowledged in 2001 that some of the methodologies were subject to uncertainty and acknowledged that the estimates of the cost per QALYquality-adjusted life year, which is impenetrable to most peoplecovered a
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wide range of values. This is an important point and I will return to the thorny subject of QALYs later. NICE also acknowledged in 2001 that
I believe that this is probably the first time that NICE has reversed a decision in such a dramatic way. It goes on to say that people currently on the drugs should be able to continue until it is considered appropriate to stop but it appears to have effectively halted the use of the drug in new patients.
I have been bombarded with letters saying that these drugs could be withdrawn as early as July. We all know that once there is a diminishing number of patients on a drug, there comes a point when the drug company will find that it is not cost-effective to carry on manufacturing it. It is not immediately clear on reading the reports why things are so different now because, in parts of the report, NICE appears to be saying that the drugs are effective. Nor is it clear why the cost per QALY is now more important and the reasoning behind the costs is opaque.
I should like to remind the Minister of the Select Committee on Health's 200102 report on NICE. One of its recommendations was that there should be greater clarity over criteria for evaluating clinical and cost-effectiveness. It recommended that
"NICE should consider the wider societal costs and advantages of particular treatments and in particular the wider costs and benefits to the public purse of reduced benefit dependency and improved ability to work both for patients and their carers".
and would be discussed with NICE. Our current argument about NICE suggests that that guidance might not have been issued, although I suspect that it was issued, but in a form that does not deal with the situation that we are faced with today.
Mrs. Annette L. Brooke (Mid-Dorset and North Poole) (LD): I am sure that, like me, my hon. Friend has received representations asking, "What kind of society are we if we are not prepared to spend £2.50 a day to give people with dementia and their carers a better quality of life?" Does my hon. Friend agree that that qualitative aspect, and the preventative aspect with regard to delaying more expensive care, must be brought into the equation?
Sandra Gidley : My hon. Friend raises a good point, which was reflected in the press coverage over the weekend, when the Under-Secretary of State for Health, the hon. Member for South Thanet, seemed to cast some doubt on the criteria used. I will return to that.
The cost issue becomes even more confusing. The estimates of the costs per QALY range from £2,000 to £139,000, depending on the length of treatment and which set of assumptions are made. For reasons that are
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far from clear, it also appears that more weight has been attached to some studies than others. For example, much weight appears to be attached to the AD2000 study. The logic behind that seems to be that that study must be more reliable than some others because it was not funded by a drug company. That is not a sensible conclusion. Some drug company trials are excellent and others are not so good, and that is also the case for more independent trials. Therefore, it is the science that must be looked at, rather than who sponsors it.
I am concerned about this, because experts in the sector have questioned the methodology of the AD2000 trial, to which a lot of weight is given. I have been sent a copy of a submission to NICE from Dr. David Wilkinson, who is a consultant in old-age psychiatry at Moorgreen hospital in Southampton. He was one of the clinical physicians on the inquiry panel. He raises a number of problems with the study. He states that the criteria were flawed because anybody who would benefit from the drug donepezil was automatically excluded from the trial and had to be treated elsewhere. Also, the recruitment was insufficient to provide detailed results; 3,000 people were supposed to be used, but only 565 were recruited, and only 20 remained at the end of the third year. He questions the implementation, too, because he says that he knows from direct experience that the measures were not carried out to ICH GCPInternational Conference for Harmonisation good clinical practicestandards. He concludes by stating:
"It was therefore a series of one-year studies with an ever-diminishing number of highly atypical patients infrequently tested by unskilled raters with consequently a great deal of missing data which by their own admission was just made up for the final analysis."
"Despite claims that no long term data were available the data from two robust one year placebo controlled studies showing significant benefit in cognition and function were rejected in favour of shorter term studies."
It is interesting that Professor James Rafferty, the chair of the appraisal committee of the AD2000 study, was one of the authors of the study. He is hardly likely to criticise his own work. That raises questions about the impartiality of NICE with regard to this particular investigation.
The Minister of State, Department of Health (Mr. John Hutton) : I did not want to intervene, but may I ask a question? Is the hon. Lady alleging some impropriety on the part of NICE in the way it has conducted the appraisal? That was the gist of her last comment.
Sandra Gidley : My point is that, in the review, NICE should have taken into account the fact that one of the
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key authors of the study on which it placed so much weight was chairing the committee. There is a case for somebody else chairing the review, and I would be grateful if the Minister considered the points that I am making. I will send him a more detailed breakdown of my argument, which I do not have time to go through today. However, I was concerned when I read the comments. I believe that NICE is generally a good thing and feel worried if anything questions its impartiality or objectivity.
The reactions to the guidance have been almost unanimous. The Alzheimer's Society refers to it as "alarming reading" and makes the point that it is worth spending £2.50 a day on drug treatments for dementia. It also claims:
"The models that NICE use do not allow a monetary value to be put on the things that mean the most to people receiving drug treatments, so they simply ignore them . . . Conventional pharmacoeconomics cannot be applied to drug therapies for dementia. QALYs inherently discriminate against older people and thus raise particular problems for calculating the costs of dementia."
One reason for the discrimination is that the calculation of QALYs usually takes earnings into account, and because the drugs are most frequently prescribed for older people who are not earning, the figures are highly skewed. We definitely need a different model when we consider the position of older people.
The college repeats some of the points already raised. It says that the economic modelling used by NICE is unrealistic and not based on the use of drugs in clinical practice, and that alternative treatments, such as anti-psychotics, will actively do harm. One feature of dementia and Alzheimer's, if untreated, is often an increase in aggressive behaviour, so we will end up using drugs that are regarded by most people as a last resort and that have been described as a chemical cosh.
Three physicians from the Memory and Assessment Research Centre have written to me pointing out the possible long-term impact of withdrawing the drugs. They point out that the only proven treatment option will be lost and that there will be a two-tier health provision for Alzheimer's, because some patients will demand private prescriptions, meaning that only those with the ability to pay will benefit from them. There is a perception that AD patients are simply being abandoned by the NHS. More alarming, many think that memory clinics will close and services for people with AD will be decimated because managers will take the easy decision to close facilities as there will be no treatment options. NICE and the Government will be guilty of ageism and will lose international credibility, and an even larger burden will be placed on our already overstretched care services.
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I will admit that I was delighted to see the press coverage over the weekend"U-turn over Alzheimer's", for example. The Under-Secretary of State for Health, the hon. Member for South Thanet, is alleged to have said:
"I can understand why the public are so worried. If you have someone in your family with dementia and you have drugs which do work then you are going to find this decision baffling. I want NICE to look at the methodology they have used, which a number of experts have called into question. It may be that once they have looked at extra evidence they will come to a different decision."
Much as I want to see the proposals overturned, the statement rang alarm bells, because I always understood that NICE was an arm's-length body and was immune from ministerial interference. Today's debate is a useful opportunity for me to seek clarification from the Minister about what form the intervention will take. The press release said that the submission was to be published on the NICE website. I looked hard at that last night and could not find where submissions were published. Will the right hon. Gentleman commit himself to publishing the submission on the Department of Health website, so that everyone can access it?
The Under-Secretary of State was also quoted as wanting NICE to examine the methodology that it used. It would be helpful if the Minister could inform the Chamber what advice has already been given or what advice is planned to be given about the methodology that should be used instead. If NICE adheres to the recommendation, as is its right, will he confirm that individual consultants should still be able to prescribe the drugs if they wish to, or will he devise alternative means of making drugs such as Beta Interferon available?
"My work involves me exclusively in the initiation of these treatments and their follow up monitoring and review. I see first hand the hundreds of lives enhanced by their introduction. I see the sometimes remarkable improvements in a patient's cognitive and social abilities, the restoration of their former personalities and the return to some semblance of normal life for families disrupted by this tragic disease."
To my mind, those words describe what must seem like hundreds of tiny miracles. That picture is repeated throughout the country. The House and the public need to know what the Government will do to ensure that such miracles are allowed to continue.
The Minister of State, Department of Health (Mr. John Hutton) : I am grateful to the hon. Member for Romsey (Sandra Gidley) for giving me the opportunity to respond to her debate. I am sorry that I am not the Under-Secretary of State for Health, my hon. Friend the Member for South Thanet (Dr. Ladyman), but I shall do my best to substitute for him.
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As Ministers, my hon. Friend and I understand the sensitivity and importance of such matters and the need to achieve the right decision at the end of the process in October. It is important to put on the record a couple of matters to which the hon. Lady did not refer. I have been in correspondence with constituents, as she will have been, about the importance of treatment and drugs. At present, about 290,000 patients could receive the drugs, but only one in six people actually receive such medication. She suggested that, if the drugs were not available, that would mean the wholesale dismemberment of Alzheimer's disease services in the national health service. She referred to the closure of clinics and the transfer of resources. I must say to her, with all respectand I have a lot of respect for herthat that statement is a grotesque distortion of reality. I hope that, on reflection, she will reconsider her words.
I turn to another important point. I did not detect from the hon. Lady's remarks that the document to which she referred is a draft for consultation. Throughout her speech, one would have gained the impression that the draft was a final decision by the National Institute for Clinical Excellence. That is a million miles away from the real position. She referred to several important and learned organisations that have expressed concerns about the draft guidance published by NICE. Those bodies should make sure that NICE has access to their views, and I am sure they will. As it has shown previously when a contested draft guidance paper has been produced for consultation, NICE is willing to revisit the basis of its initial proposal. It took such action with the proposed draft guidance on macular degeneration, with a view to making sure that its evidence is the best and reflects fully the available clinical, medical and scientific research. The hon. Lady assumed throughout her remarks that a decision has been made to withdraw the treatment that is provided. That is not the case. I am glad that she is acknowledging my remarks.
The Government are committed to improving the standard of care for those with dementia. The national service framework for older people that we launched four years ago sought to promote good mental health in older people and high-quality treatment and support for those with dementia and depression. The national service framework aims to ensure that older people have access to integrated NHS and local authority mental health services, providing effective diagnosis, treatment and support for those with mental health difficulties and their carers. I believe that we are making real and solid progress in that sector.
In 2003, to support implementation of the national service framework, the Secretary of State for Health announced that, as part of the eighth wave of its work, NICE would produce a clinical guideline on the care of those with dementia, including the use of Alzheimer's drugs. NICE is scheduled to issue a consultation version of that clinical guideline in spring 2006.
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Hon. Members will be aware of NICE's recent review of guidance on the use of drugs for Alzheimer's disease and the publication of its draft guidance for consultation. The hon. Lady spent much time referring to that. NICE suggests that the use of the Alzheimer's drugs covered by its 2001 guidance can no longer be considered clinically effective or cost-effective, and that they should not be offered to new patients by the NHS. The draft technology appraisal produced by NICE and issued on 1 March is a consultation document. The consultation period closes on 22 March.
The hon. Lady asked me on what basis NICE took the decision to issue that advice. NICE has said that the reason for the proposed change of advice is the availability of more recent evidence on clinical effectiveness. She has sought to challenge that, as she is entitled to do.
NICE will carefully consider all the responses to the consultationI am sure that the hon. Lady will make a responsebefore issuing its final guidance in October 2005. Until then, the original 2001 guidance from NICE should be adhered to and patients currently being prescribed Alzheimer's drugs should continue to receive them.
I remind the Chamber of a point with which I hope that many hon. Members would agree: NICE has a strong track record and has built an international reputation for its work on clinical effectiveness and cost-effectiveness. Indeed, its methodologies have been commended by the World Health Organisation. Since NICE was established in 1999, it has issued 88 technology appraisals and 25 clinical guidelines, benefiting many thousands of patients.
However, I know that questions have been asked about the methodologies that NICE has applied in preparing its revised appraisal for Alzheimer's. It is right that such issues should be aired and that they are logged formally with NICE during the consultation period, so that it can consider their implications for its final guidance. I hope that all those with an interest will share their views with NICE during the consultation. My hon. Friend the Under-Secretary has been communicating with lobby groups and expert bodies to ensure that they submit all the available evidence of efficacy and explain to NICE any reservations that they have. The Department of Health will respond to the consultation, as is its normal practice when NICE issues draft guidance.
The Department of Health's response will touch on some specific areas that I know are of concern to the hon. Lady. It might help if I highlight some of those specifics. For example, we shall ask NICE whether it is content that the wider impact of those drugs, particularly on carers, is given appropriate weight and is adequately reflected in the guidance. We shall also ask NICE whether it believes that its appraisal fully captured the evidence on the effectiveness of those drugs in improving cognitive functioning, and the extent to which any such benefits may persist beyond the short term. In addition, we shall raise other issues, such as the potential costs and side-effects of alternative medications such as anti-psychotics, which might be prescribed for the behavioural and psychiatric symptoms of dementia should the existing Alzheimer's
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disease drugs be used far less extensively. Our response will also highlight the inter-relationship between those drugs and wider services for Alzheimer's disease such as memory clinics.
That is not, of course, a comprehensive account of the Department of Health's response to the NICE consultation, but I wanted to assure the hon. Lady that we understand the issues that are being raised and that we will, as always, use our own consultation response to highlight issues that we believe to be important.
Sandra Gidley : I thank the Minister for the broad outline, but will he indicate how the public will be able to access that response? That does not seem to be clear at present and there is bound to be a lot of interest.
Mr. Hutton : I was just coming to that point. The hon. Lady asks if we are going to publish our response to the consultation. Yes, of course we will. It will be published on our website and we will put a copy in the Library, so that she and other hon. Members can see it. I do not feel that it is appropriate to go through every nook and cranny in my response, as we do not have enough time, but I wanted to give her the sense that we share some of her concerns. We intend to publish our response fully in the appropriate way.
It is worth pointing out that, in doing so, we are not questioning NICE's processes or its track record in providing good quality, evidence-based advice to the NHS. Nor do we seek, as some press reports suggest, to overrule the national institute or to direct it to reach a particular conclusion. The hon. Lady expressed concerns that we might be preparing to do that. I hope that she is reassured.
I said that NICE is developing comprehensive guidance on the provision of dementia services in the form of a new clinical guideline. Clearly, it is important that the guideline links coherently with NICE'S final assessment of drugs for Alzheimer's disease. We will wish to discuss with NICE how the timing of those two pieces of work is best managed, so that patients, carers and clinicians have access to a single suite of advice covering the management of the condition.
The hon. Lady rightly, and for good reason, confined her remarks primarily to the draft NICE guidance. In the two or three minutes left to me, I would like to widen the debate slightly. It is important that we look at other issues surrounding the care and treatment of people with Alzheimer's disease. In that context, we should not forget the role of families and carers supporting those with dementia. The majority of people with dementia are cared for at home, which can be an incredibly demanding and exhausting task for the carers.
We were the first Government formally to recognise the contribution and concerns of carers. In 1999, with carers and the organisations that represent them, we developed the national carers strategy. We also introduced a carers' grant to support councils when providing breaks and services for carers in England. The grant has been steadily increased every year, and it has provided an extra £325 million over the past five years. It is worth £125 million this year, it will be worth £185 million next year and, in the last local government finance settlement, we confirmed our commitment to continue the carers' grant until the end of financial year
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200708. Local authorities have been able to use the money to give carers help with taking breaks from caring, and to give them ongoing support with caring. That was a hugely important step.
There is another context to the debate, which was raised when the hon. Lady expressed concern about resources. In July 2002, the then Secretary of State for Health, my right hon. Friend for Darlington (Mr. Milburn), announced a wide-ranging package of measures radically to reform services for older people. By 2006, compared with the resources available today, another £1 billion a year will be spent on social services for older people. The package focuses on six main themes: faster assessment, stabilising the care home sector, an expanded range of services, easier access to community equipment, increased choices for older people, and more support for carers. All those services are of relevance to older people with dementia.
Sandra Gidley : All those services are welcome, but will the Minister acknowledge that the biggest problem facing people with Alzheimer's may be the difficulty of obtaining continuing care funding? Their needs often involve a lot of personal care, which is not funded. As a result, people feel discriminated against because they believe that their needs are related to the health condition.
Mr. Hutton : Again, we have tried to address those issues. The hon. Lady will be aware of the ombudsman's ruling on the application of the rules on continuing care. We are working hard with the NHS to ensure that the outstanding cases are processed speedily and efficiently.
It is worth bearing in mind the fact that the NHS spends considerable sums every year on providing continuing care. In that context, continuing care does not cover personal and nursing care only. It covers the entire cost of accommodation, including the board and lodging of the person, and rightly so, because the NHS's responsibility is to provide the health care that people need. If a person's needs have been assessed as being predominantly health related, it is the NHS's job to fund that care. Meeting the concerns of the health ombudsman in dealing with the backlog of cases will cost the NHS about £180 million
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