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Health: Clinical Decisions

Volume 687: debated on Tuesday 12 December 2006

rose to ask Her Majesty’s Government whether the indirect social costs of clinical decisions are being met by government departments other than the Department of Health.

The noble Baroness said: My Lords, I welcome the opportunity to discuss this important issue. The entire thrust of the Government’s health policy is towards prevention and early intervention and, in their care policy, towards maximising independence, autonomy and dignity. The guidance, therefore, that NICE issued last November on treatment for Alzheimer’s disease is illogical on two grounds. Withdrawing the drugs in the early stages of the disease clearly undermines the strategy on prevention. In the appeal statement, NICE stated,

“the appraisal committee is not required to consider the broad clinical priorities of the Secretary of State”.

Should we ask how the clinical priorities are to be met when NICE’s guidance acts in the opposite direction?

For early-stage Alzheimer’s sufferers, that decision also puts doctors in an invidious position, knowing that their patients have to get worse before they get treatment. Equally, the decision undermines the Government’s dignity in care priorities. In the introductory preamble to the dignity in care campaign, launched barely a month ago, some elderly people were quoted as saying that they felt neglected or ignored while receiving care. They felt that they were worthless or a nuisance and that they cost too much. It would be hard to imagine a more graphic example of a decision that was calculated to lead to a loss of dignity than the withdrawal of treatment that NICE acknowledges is clinically effective in the early stages of Alzheimer’s. If there had been serious doubt about the clinical effectiveness of these drugs, there would have been no outcry. However, the decision is not being taken on clinical grounds. This is particularly poignant, given that dementia strips the sufferer of so much autonomy and dignity.

NICE has an essential role and does an excellent job within its current remit, but issues arising from this decision should be re-examined, as they go to the heart of what the debate is about. Published figures do not include costs that are exported to other government departments, such as benefit costs to the DWP or care home costs to the Department for Communities and Local Government. NICE has acknowledged, for instance, that it had not accurately represented the true costs of long-term care, which are between £355 and £520 a week for full-time institutional care. Given regional variations, this is seriously inadequate. If these costs are to be factored into the decision, they must be accurately assessed in the first place. Surely one of the prime aims of treatment is to delay the moment when expensive institutional care is required.

We know that, if we can put off the need for full-time residential care for a reasonable period in the early stages of Alzheimer’s disease, many people, usually the very elderly, will die from some other cause before they need to go into an institution. That could save a considerable amount of money, and surely that must be taken into account, too. Equally, NICE has acknowledged that more research is required, and there is clearly a need for greater clarity about the ability of these drugs to slow progression. Why not continue to make these drugs available and monitor the outcomes so that we may know more and reach a more informed decision?

We know that if these drugs are not prescribed until the later stage of Alzheimer’s, some patients will instead be given powerful sedatives that are less acceptable and more costly. NICE acknowledges that that is outside the scope of its decision-making, but this cannot be ignored. NICE also recognises that QALYs—quality-adjusted life years—are a very blunt assessment tool for dementia and, even taking into account the compensation mechanisms that have been introduced, we know that they lead to unfair outcomes for older people in many cases.

Moreover, the appeal panel that looked at this was not independent. Three out of five of the members were from NICE itself, and there was only one patient representative. I understand that, in 2002, the Health Select Committee recommended that the Government change the appeal system. Will the Minister agree to look at this again? In practice, although NICE says that its decision is merely guidance, we know that the drugs are not likely to be prescribed after this guidance has been issued. However, patients already receiving treatments are allowed to continue to do so. This is not logical, and it compounds the unfairness of the situation.

Lastly, the impact of denying clinically effective treatment to these groups has a profound impact both on carers and on the wider economy. With treatment, those with early-onset Alzheimer’s might be able to remain economically productive during this period—if not in employment, then certainly as active members of society who can still shop for themselves, travel, and sometimes even volunteer.

As we know, carers may earn only £84 a week before the carer’s allowance is withdrawn. Currently, they need to provide at least 35 hours of care a week to qualify, but they can claim very much more if they are not working and are on income support. They can claim income-based jobseeker’s allowance, housing benefit, council tax benefit, a carer’s premium and so on, all of which is much more costly. Approximately one in eight workers in the UK combines work with care responsibilities, but despite the very welcome legislation brought in by the Government in the last Session, there is still discrimination by employers and resistance to flexible working. The stress can hold back performance and even lead to people giving up work. All too often we see a vicious circle in which those with care responsibilities develop health needs of their own, which inevitably costs the NHS more money.

According to Carers UK, people with care responsibilities of more than 50 hours per week are more than twice as likely not to be in good health than those without. The same survey found that 27 per cent of people who provide more than 20 hours of care a week have mental health problems, too, compared to 13 per cent of those giving less than 20 hours. Of people who provide high levels of care, 316,000 are permanently sick or disabled. Low incomes, plus inadequate respite services, contribute to their ill health. Therefore, providing long-term care effectively rules people out of the workforce permanently. The peak age group of carers is 50 to 59 and, if their paid labour is lost, the Government undermine their aims of ensuring that more older people return to, and remain in, work and thus help to meet the objectives of the Pensions Bill, which was only just introduced.

Of course, not all carers look after people with dementia, but it is acknowledged that dementia patients are among the most challenging for carers. It is also known that the number of people in the UK with Alzheimer’s alone will almost double to 1.2 million by 2025. Anything we can do to mitigate the impact of this condition and its wider costs to society should be considered.

I end by pointing to the real cost of giving people who have early-onset dementia access to these drugs. To give the House an idea of how paltry the sum is, if the cost of funding these drugs was spread equally across the entire population of England and Wales, it would amount to 1.5p per person per month. If no money is available for this, what has happened to our country? Is it not worth this tiny sum of money to give people hope and the chance of some quality of life? I hope that the Minister will accept that NICE really must look again at its decisions and that the Government must look again at how they, and we, measure the true costs and benefits in such very difficult situations.

My Lords, I thank the noble Baroness, Lady Greengross, for the opportunity to debate this important issue, even though there are only a few of us who want to do so. NICE does a fantastic job. Setting it up was far-sighted and visionary. As it must, it takes decisions with reference only to the efficacy of the drugs and treatment that it regulates. We cannot expect NICE to consider the knock-on effects of its decisions, but that exemption does not apply to the rest of us and certainly not the Government. We are not considering only NICE decisions on drugs; clinical decisions such as delayed operations or early discharge clearly have an effect on other people and departments. Nowhere is that more apparent than in the effects on the patient or potential patient’s family, who, as we heard from the noble Baroness, are often the main carers.

Clinical decisions can affect a carer’s ability to work, their stress levels, physical health and overall quality of life. How these costs are borne by other departments and agencies is perhaps best illustrated with an example provided by Carers UK. Let us look at the example of a couple in their early 50s who still have children at school. The husband is in the early stages of Alzheimer’s disease and therefore could benefit from the drugs. We will call the carer “Jean”. Since her husband had to give up work, she is the main breadwinner. Without the drugs being prescribed for him, Jean, too, is on the verge of giving up work. If her husband had received the drugs, perhaps she could have stayed in work for a few more years, which is critical, given that she is part of a final salary pension scheme, and her children would then be old enough to go to university or to work.

What are Jean’s costs and what other departments are affected? The carers’ family allowance and benefits that they would not otherwise have claimed from the Department for Work and Pensions are over £7,000 a year, which does not include the administrative costs. Jean is no longer contributing to her pension. This affects the Treasury, through future loss of tax once Jean has retired, and the wider economy through the loss of her greater spending power. Jean is no longer paying national insurance credits, as she is not in work, so that is a loss to the Exchequer. She is no longer paying tax, and that affects the Treasury too. Like many carers, Jean is depressed because of the stress and the lack of choice about giving up work to care. She has been prescribed anti-depressant drugs, a Department of Health cost. The company that she has had to leave has had to recruit a new worker. This will cost it £12,000 in profit; the Treasury receives less in corporate tax.

We must also consider the longer-term costs, because Jean may now never return to the labour market—in fact, she probably will not—and that will affect the Department for Work and Pensions, the Department of Health, the Department of Trade and Industry, the Department for Education and Skills and, again, the Treasury. The total costs are likely to be larger than the direct costs of either drugs or substitute care to the Department of Health.

Other clinical decisions affect carers. The decision to prescribe one drug over another may mean that someone copes better and the carer has to do less. This happens in treatments such as that for Parkinson’s disease, where the balance of the drugs is critical. But the carer’s opinions about how drugs affect people are often not taken into account. This is often for the very best of motives on the part of the prescribing clinicians—they do not want to trouble the carer—but what the carer feels is something less than a partner in the provision of that care. The decision not to carry out an operation but to wait for a more productive time for either the service or the patient can often make the difference between the carer giving up work or staying in work.

We should never forget that there are 6 million carers—I remind your Lordships of this endlessly; I am sorry to be boring—one in five carers gives up work to care, and carers save the state about £57 billion a year. As we have heard, carers are twice as likely to suffer ill health, both physically as a direct result of caring—for example, from back injury—and from the huge effects of stress through confinement in the home and the fact that the caring takes place in a relationship. As we all know, relationships are not all sweetness and light, even when you do not have caring imposed on you, and emotional stress can take a very severe toll on the carer.

This problem is not going to go away. Carers UK estimates that, in 20 years’ time, we shall need 3 million more carers to cope with the demographics in our society. We will have to address this issue over the next few years.

The Government have a fine record on carers, which is the envy of the world. I do not say that lightly. I speak on carer issues throughout the world and I see the envy—the wonder even—in which our country is held for the way in which it was the earliest to address carer issues and to do many things about them, from the three Acts of Parliament for carers to the latest influence on pensions and the Work and Families Bill, which provides for more flexible working.

We have a fine record on carers, but perhaps the Government could be persuaded to do a few more things. For example, could the Department of Health evaluate how clinical decisions are liable to have an impact on carers, perhaps as part of the review of the National Carers Strategy, to which the Government are committed? Would it be possible to issue guidance to clinicians about taking the carer situation into account—specifically, if we need to limit it, the carer’s ability to go on in paid work and the knock-on effects of that?

The Government’s commitment to preventive initiatives, as outlined in Our Health, Our Care, Our Say, is very welcome. Too much care is focused on crisis situations, with many local authorities withdrawing early intervention—intervention which can enable carers to go on caring for much longer. It makes very sound economic and moral sense to support carers—I know that I do not have to convince your Lordships of that. We must continue to move on with this policy if we are to ensure that caring families will continue to be supported as they deserve.

My Lords, I declare an interest as an employee of Age Concern England. I thank the noble Baroness, Lady Greengross, for shining light on this dimly lit recess of health and social care policy. It is a much needed illumination as we tread the path towards the Comprehensive Spending Review, which will have a significant impact on all aspects of health and social care.

As the noble Baroness said, the debate has been prompted by the public reaction to decisions on the availability of drug treatments for Alzheimer’s and the NICE pronouncements. I will focus most of my remarks on that issue, but there is one other thing I want to mention which is in danger of passing unnoticed.

Unfairly, in my view, much of the criticism has been directed towards NICE and its approval statements. As health spokesperson, I meet lots of people who work in and around the health system, and I wish I had a pound for every time I heard the phrase “I am a big supporter of NICE, but…”. NICE is extremely important but it has been dealt an almost impossible hand. It is one thing for the Monetary Policy Committee of the Bank of England to make technical decisions on a narrow matter about which there is a large degree of consensus; it is something else entirely to be given the task of making clinical, technical decisions in an environment where there is neither technical, economic nor political consensus on matters which are highly emotive in social and personal terms. That is what NICE has been asked to do.

In the wake of the Herceptin judgment, a technical judgment made in the face of an aggressive, emotive campaign funded by the supplier of the drug, it is important that politicians reaffirm their true support for NICE and, at the same time, take responsibility for political judgments such as allocation of resources, which NICE should not be expected to make.

We live in an age, and will do so for the foreseeable future, in which new drug therapies will emerge that offer people hope—sometimes the only hope—of survival or the only hope for added years of life. For both groups, there is a huge benefit to carers and relatives. At the moment, the availability of those drugs offering hope is determined by a combination of NICE judgment and PCT budgets, yet decisions on budgets are made nationally only. Would the Government consider whether funding could be reserved for each primary care trust each year to enable it to purchase new drugs as they are licensed, come on-stream and achieve NICE approval in the middle of a financial year? That fund could be available for clinicians to use as they saw fit in response to emerging local need.

The noble Baroness, Lady Greengross, talked about the four licensed drugs for Alzheimer’s—Aricept, Reminyl, Exelon and the most recent drug, Ebixa. She also talked about the cost of prescribing them, which is about £2.50 a day. NICE agrees that those drugs are clinically effective but they are not cost-effective enough to be provided. By law, NICE is allowed only to consider the costs and benefits of the treatment to the NHS and to statutory social services, as well as the impact on an individual patient. If a treatment provides wider social benefits—for example, to carers—that factor is excluded from the evaluation process. That is wrong; the system should be changed so that NICE, in conjunction with those responsible for resource decisions, can make those decisions. In principle, if NICE could make those judgments it would be allowed to get on with its job. It would be wrong, in those circumstances, for non-expert politicians to attempt to influence politically the process of evaluating the cost-effectiveness and clinical effectiveness of treatments.

However, we are not in that situation in the case of these drugs. There are concerns about the way the appraisal of these drugs was carried out. Why did the appraisal not include the potential need in the NHS of treatment for aggression, which Alzheimer’s patients may need if they do not get these drugs? Is the use of the quality-adjusted life year appropriate as a measure for people with dementia? Why did the guidance from NICE fail to clarify that it should not apply to people with a learning disability? How independent is the NICE appeal process when, as the noble Baroness, Lady Greengross, said, the majority of the members of the appeals panel were members of NICE?

I, too, shall touch briefly on the issue of carers. There are 6.8 million of them in Britain, 80 per cent of whom are under 65. The noble Baroness, Lady Pitkeathley, can tell us in her sleep about the difficulties they have achieving flexible working arrangements and moving to part-time work. Many of us in this House now know that as well as she does, and I am glad she keeps reminding us. However, the cost of caring has an impact well beyond the point at which the carer has to carry out their caring activities.

Dr Maria Evandrou of the LSE has contributed a number of different studies on the continuing effects on, particularly, the pension contributions throughout retirement of people who have had caring responsibilities. It is not just occupational pension schemes that are affected, as the noble Baroness said, but quite often, particularly in the case of women, entitlement to the basic state pension. They simply do not have enough qualifying years to be eligible for a full basic state pension, so that they then go on to accumulate an enduring entitlement to pension credit. That, set against the cost of the drug treatments that might enable them to continue working while the person they are caring for is in the early stages of Alzheimer’s disease, needs to be calculated by NICE, not by itself but in conjunction with those responsible for resource decisions.

I shall briefly mention one other decision; it is not exactly a clinical decision, but it is a medical one, and it will have a significant impact on older people, in particular those with Alzheimer’s and their families. The NHS is about to announce a tightening of the criteria for NHS continuing care. At present 20,000 people are deemed to be in need of nursing care, and they have their costs met by the NHS. Social services departments and campaign groups have already said that the existing criteria and the Department of Health’s interpretation of them are so narrow that a further 75,000 people are being denied care, or having to pay for their own care, when it should be met by the NHS. A series of court judgments and statements by the ombudsman have backed that up and said that the NHS should be more lenient in its interpretation.

If a person with Alzheimer’s needs to be fed and washed, that is nursing care, not personal care, yet at the moment for many people it is being judged differently. If the Government make those criteria even tighter, more people will have their care funded, not by the NHS, but by social services. Estimates suggest that that would add an average £5 million to the social services bills, which equates to an extra 1 per cent on council tax bills. The number of people living with dementia, particularly Alzheimer’s, is set to rise, so those costs could be even higher than anticipated.

The noble Baroness, Lady Greengross, talked about the increasing number of people who will live longer with conditions such as Alzheimer’s. We also know it is most likely that people who are very elderly and live for a long time live in areas of greater affluence; therefore, there is a correlation between not just the number of older people living longer but the places where they live. That means that there will be disproportionately high costs in some areas and for some statutory authorities. I have not yet seen anything from the Government that has reflected the disparity of costs across different areas.

The future for people with Alzheimer's and their carers is bleak, and the combined effect of those two judgments will make it even bleaker. At a time when the NHS locally and social services are being forced to find ever more cost-efficient ways of providing treatment and care, should not central Government face that same discipline? If they did, they would come to different judgments about the actual cost, across the piece, of care and treatment. It is time for some joined-up thinking.

My Lords, I, too, thank the noble Baroness, Lady Greengross, for raising this debate in your Lordships' House. I declare an interest as a healthcare provider.

The NHS had a gross deficit of some £1.77 billion in 2005-06. That figure directly impacts on the amount of money available to PCTs in drug purchasing—in particular, it impacts on the availability of drugs for the elderly in the treatment of Alzheimer's, as highlighted by the noble Baroness, Lady Greengross. Some 16 per cent of the UK population is now aged over 65 and, with declining mortality rates, a huge demographic shift is occurring. In 2004-05, an estimated 1.72 million people received some form of health and support from social services in England. Some 71 per cent of them were aged 65 and over.

The White Paper, Our Health, Our Care, Our Say, announced in another place in January this year by the Secretary of State, Patricia Hewitt, committed the Government to extending the emphasis on non-hospital care. She said that four themes clearly emerged from her consultation: more emphasis on prevention with earlier intervention; more choice and say for people in the services that they receive; more support for people, in particular those with long-term needs; and more work to tackle inequalities and to provide more services within local communities. Despite the Government's commitment to a new generation of community hospitals, 81 are still under threat of cutbacks or closure, according to the Community Hospitals Association.

It seems obvious to me that early intervention not only helps those requiring treatment but impacts greatly on those who are expected to contribute in meeting the needs of others. It is, therefore, curious that, in cases of low and moderate dementia and Alzheimer's, recommendations are being made by the National Institute for Health and Clinical Excellence not to provide drugs such as Aricept, Exelon and Reminyl on the NHS. The Alzheimer’s Society and others have highlighted the fact that appraisals by NICE were void of any consideration of social and welfare costs to other government departments, in particular the costs of meeting the social and personal needs of patients who fall short of the eligibility criteria for care prescribed by social services. Meeting the social and economic needs of the carers and the cost of respite provision—and, of course, ensuring its availability—is crucial to preventing suffering in relation to long-term care.

It is right that we should have an independent body that carries out proper and detailed investigations into the availability of drugs on the NHS, but the decisions made by NICE must be transparent and accountable to ensure that both the patient and the taxpayer have confidence in the outcomes. There has to be clarity on how costs and benefits are measured in both health and social care. What should also be measured are the costs to voluntary carers who, because of taking up the responsibility of providing care, are removed from the economy, and the impact of this to the quality of their lives and their needs.

In highlighting the impact of NHS deficits on social care, my colleague in another place, Stephen O'Brien, said that NHS deficits were adversely affecting local authorities and that patients were suffering as treatment was removed from the NHS to means-tested social services. A more in-depth look at the methodology of how NICE arrives at its decisions may be needed.

The use of health technology assessment has become increasingly key in decision-making in the UK. HTA attempts to assess the value of new technologies to the health system by determining the amount of additional health gained for a given financial cost. The method used—the quality-adjusted life year—appears to be a very blunt tool to assess the value of medicines, as other speakers have stated. It attempts to combine assessments of the impact of medicine on both life expectancy and quality of life. Many feel that QALYs discriminate decidedly against older people because benefits are registered by treating people with longer life expectancy. Most economists recognise that QALY calculations pose significant limitations on creating a single method by which the value in changes in health can be calculated. Often, therefore, HTAs generate a wide range of cost per QALY estimate, leading to contestability of their results and interpretations.

It is also reasonable to say that this approach cannot be a useful tool for all medicines. The health technology assessment must ensure that risk-averse decision-making does not create barriers for innovation or deny patients access to medicines. HTA must take into account the views of physicians and patients far more than it does at present. They are essential in assessing the value of medicines and decisions taken on healthcare provision. HTA must also engage more vigorously with manufacturers during drug development to ensure that guidance is duly available during the production process and to allow ample time to respond to concerns.

Why, when NICE thought that the QALY approach was inappropriate in the original Alzheimer’s disease assessment—it was considered unreliable—did it go on to use that approach in ongoing appraisals? Does the Minister know how much engagement NICE has with drug manufacturers during the drug development process? Can she assure the House that financial considerations regarding the NHS and social services budgets are not the only factors when deciding what drugs should be made available to patients on the NHS?

I return to the question at the heart of this debate—enabling patients in the early stages of dementia and Alzheimer's to access on the NHS the drugs that will help to delay these incredibly debilitating illnesses. It is difficult enough to have to see your loved ones undergo such enormous personality changes with the onset of dementia and Alzheimer's. Caring really becomes full of challenges that you had never expected to see or deal with when the very people whom you love and care for so much gradually become unaware of events happening around them. Is it too much to expect that all that can be done should be done? Quality of life for all must remain at the heart of all decisions made on behalf of patients and their carers. We cannot shift the costs of meeting these needs to other departments just because NHS deficits have to be met and we certainly cannot short-change the British public.

My Lords, I am grateful to the noble Baroness, Lady Greengross, for enabling us to have this debate on such a key issue. I wish that more noble Lords were present this evening, but clearly we have quality if not quantity. I am glad to see the noble Baroness, Lady Verma, on the Front Bench opposite. It is the first time that I have had the pleasure of addressing her across the Dispatch Box.

The noble Baroness, Lady Greengross, has a fine record, especially on age-related matters, and the concerns that she raised today are clearly important in relation to her work with the International Longevity Centre, the Alliance for Health and the Future, and Care and Repair. I very much welcome the opportunity to respond to her comments and those of the noble Baronesses, Lady Barker, Lady Pitkeathley and Lady Verma.

I also welcome the emphasis that there has been this evening on carers. As a society, we are indebted to the more than 6 million carers that we have in the UK, but as my noble friend Lady Pitkeathley stated, the Government recognise the tremendous contribution that carers make to our society and the importance of supporting them. We have done much to improve their lives. For example, we set up a carers’ helpline to help them deal with emotional stress and to provide practical advice and we brought forward the expert carers’ programme, which offers support and gives carers the skills to carry out their vital role. There is much more that we are doing and much more that we should do; and we will persist in this.

The National Institute for Health and Clinical Excellence—NICE—was established to give advice to the NHS on best clinical practice, including the clinical and cost effectiveness of drugs and other treatments. I assure the noble Baroness, Lady Verma, that cost is not the only issue that is examined. NICE has achieved a huge amount in the past seven years and has a broad base of support across government, the health professions and the pharmaceutical industry. I was glad to hear that this evening in the Chamber. Few would question the value of its recommendations or its integrity, although its work can inevitably be controversial. We owe it our strong support, but clearly it is also right that we debate and question the way in which it works, and the way in which NICE guidelines relate to government priorities such as prevention, community care, tackling inequalities and dignity and care.

NICE is well known for operating in an open and transparent way. Since its establishment in 1999, the institute has striven to make available in the public domain much of the information used in its guidance development process. Furthermore, NICE has responded positively to recommendations made over the years to make even more information available. The methods by which NICE reaches its conclusions are also readily available and are subject to much scrutiny. Open discussion of NICE’s processes and methods is of course vital to the institute’s continued development and success, and is to be encouraged. NICE publishes the manuals for all its guidance processes on its website, where they are freely available for public scrutiny. I had a good look at the NICE website today, and it is very well managed and easily accessible.

I fully appreciate that some of the issues cited by noble Lords today have also been discussed with reference to recent appraisals published by NICE. Significant questions have been raised in this House and more widely about the way in which NICE conducts its vital, but sometimes difficult, work. Some of the issues concern NICE’s methodologies and related issues of health economics. It would not be appropriate for me to go into detail on specific appraisals that are the subject of appeals and, in one case, the possibility of a judicial review. However, I note what noble Lords have said about Alzheimer’s specifically. While I cannot make detailed comments, I would say that the technological appraisal for Alzheimer’s drugs needs to be seen as part of a package with NICE’s clinical guideline on the treatment and care of people with dementia, which was published jointly with the Social Care Institute for Excellence on 22 November. The clinical guideline complements the guidance on drugs by making it clear what care and support should be provided to people in all stages of Alzheimer’s disease. Indeed, it also addressed the needs of carers as well as those who suffer from dementia.

Some criticisms of NICE have underestimated the sophistication of its methodologies and the wide range of factors that it already takes into account. NICE’s assessments reflect all aspects of benefit to health arising from a treatment. That includes the benefit of improved health, but crucially, also the benefit derived from things that a patient can do because they are feeling better; for example, going to work. Because such benefits are already covered in NICE’s methodologies, separately taking account of wider economic benefits runs the risk of double counting.

I am aware that NICE has been accused of carrying out its appraisals on too narrow a cost base by excluding indirect social costs arising from the use of a treatment and therefore creating cost pressures for other government departments. However, as I have already stated, NICE is able to take into account wider societal benefits, and this is explicit in the institute’s Guide to the Methods of Technology Appraisal.

I note noble Lords’ comments that the appeals process is not truly independent. I believe that it is independent of the guidance development process. The appeal panel is chaired by a non-executive member, has two independent third parties and usually two other non-executive directors of NICE who have had no previous involvement in the appraisal in question. Appeal hearings take place in public and the panel’s considerations and conclusions are published. However, the appeal system will be within the scope of NICE’s review of the appraisal process and methods, which I shall speak on later. I urge noble Lords to participate in that review process, particularly in relation to appeals.

I do not pretend that these are simple issues; indeed, we must expect that NICE as a global leader will have to deal with many issues on which there is no universal agreement in terms of the science and methodology. I am sure that noble Lords will understand that, as in any complex field, the specific approaches that NICE adopts will have both their supporters and critics. This is to be expected and it is healthy. NICE is willing to learn in the development of its appraisal methodologies. Noble Lords will be aware that the processes adopted by NICE are not static. The institute has a well earned international reputation for operating at the cutting edge of technology assessment, which was reflected in the review of NICE’s technology appraisal process, carried out by the World Health Organisation in 2003. The WHO marked out NICE’s appraisal methods as setting something of a gold standard and stated that they represented an important model for technology appraisals internationally.

For NICE to remain at the cutting edge, its processes must of course develop over time. The noble Baroness, Lady Verma, suggested that the methodology of appraisals needed to be re-examined, but she and other noble Lords will be glad to know that NICE’s guidance development processes are subject to periodic review, which includes public consultation. Its technology appraisal process was last subject to such a review in 2003-04. That process involved full public consultation and extensive work with academics, patient groups, the NHS and industry. NICE will be undertaking a further scheduled review of its appraisal methodology in 2007. In addition, I understand that the Health Select Committee has announced its intention in 2007 to hold an inquiry into NICE, following its 2002 inquiry, although the terms of reference have yet to be published.

NICE’s review will again involve active engagement with key stakeholders, including patient groups and academics, and a public consultation. I understand that the review will potentially cover a range of issues, including how NICE considers carer benefits, the use of the quality-adjusted life year (QALY)—as was raised by noble Lords—and the way that NICE takes account of wider societal benefits. In keeping with its open and transparent mode of operation, NICE will publish details of this review in due course. I urge all stakeholders in NICE guidance, including noble Lords, to support the consultation next year and engage in the process. This debate is timely, because only through healthy public debate of its work will NICE improve further and consolidate its position as a world leader in the field.

The noble Baroness, Lady Barker, raised the question of a special fund for drugs. She will not be surprised to know that that would not be compatible with the Government’s policy of allowing local health services to take decisions on how they can best meet the needs of their patients. There is no pot of gold hidden in the Department of Health. Every penny used to set up the fund would come out of allocations to primary healthcare trusts. However, I hear what the noble Baroness says and I undertake to explore the matter a little further.

The noble Baroness, Lady Verma, asked about NICE’s engagement with drug companies. It has a dialogue with drug companies both generally and through consultation and specific appraisals. The industry’s views will also be important as part of NICE’s review of process and methods.

Many noble Lords referred to benefit payments and the potential for NICE to take formal account of the impact of health interventions on benefits such as those paid by the Department for Work and Pensions. Although the aim of such a suggestion might be to ensure that any savings accruing from better health in the form of reduced benefit payments are taken into account, the effect might not be quite as intended. However, I think that noble Lords were looking at a broader aspect of that issue.

The NHS devotes significant resources to healthcare interventions for elderly patients, many of whom may be retired and receiving a state pension and possibly other benefits. If a healthcare intervention prolonged the life of someone in receipt of such payments, the cost to the state in pension and other benefits would increase, not decrease, as a consequence of investment in that intervention. I am sure that none of us would want to see that kind of reasoning factored into an appraisal, but it illustrates that we cannot assume that healthcare interventions will reduce spending on benefits. Therefore, taking such interventions into account would not necessarily lead to a more favourable account.

It is important to continue to debate these issues, and clearly the focus of the debates will evolve as NICE’s processes and methodology evolve. I hope that there will be real interest in the consultation on NICE’s appraisal methodology next year, and I expect continued interest in how the institute responds to the comments received. Noble Lords should be reassured that there is a proper and public process for identifying and systematically addressing the kind of important issues that we have been discussing today. Indeed, I am sure that many of the issues raised in today’s debate will affect the way that NICE works in future. There are many challenges ahead for NICE but I am absolutely confident that it is up to the challenge.

House adjourned at 7.07 pm.