National Institute for Clinical Excellence (Hansard, 8 July 2003)

§ Mr. Dai Havard (Merthyr Tydfil and Rhymney)
I want to make three essential points. The first is on a particular matter that I have been examining—I think that you chaired a previous debate on this, Mr. Deputy Speaker—which is the use of blood, and the alternatives, in cancer. I want to use that as an illustration to lead into my second point, which is the processes that the National Institute for Clinical Excellence allows, and what happens after them. Finally, I will look at how we can make change and improve those processes in doing so.
I am a great supporter of NICE. It was a great idea to set it up. It is a world-class organisation, largely because of the quality of the people involved in it and the integrity of its processes. That is shown once NICE makes a recommendation in the way in which that is accepted in the community. It deals with the right range of matters. It deals with clinical guidance for all conditions, medical interventions and the broader question of technologies—not only physical equipment, but such things as drugs.
One of the great things about NICE is that it has a citizens council. It tries to be participatory in a range of ways, and those can be applauded as ways forward. It tries to address postcode prescribing, as it has been called—consistency in the application of treatments once they have been decided on. It is timely to have this debate now—more timely, in fact, than I initially understood—because having done a little research, I find that the World Health Organisation is conducting a peer review into some of NICE's activities and that NICE has announced its own reviews of its appraisal processes. It is almost exactly 12 months since the Select Committee on Health did serious work on the operation of NICE.
Some 18 months ago I looked at the predicament of cancer patients who suffer from the debilitating effects of anaemia stemming from their treatment. Blood transfusions are used as part of the process to help with that and are one of the main treatments for that common side effect of cancer. I discovered that 30 per cent. of the blood supply is used for that.
Over that period, I have asked 40 ministerial questions and had two Adjournment debates in Westminster Hall. There are clear alternatives to using blood transfusions, such as a drug process called Erythropoietin, more commonly known as EPO. EPO has been licensed for use in the national health service since 1995, but NICE, newly established since then, has not approved that as the normal practice that should operate, which is interesting. Were it to do that, its application would clearly have a different effect than at present. Last November, the Department of Health indicated that it was considering referring EPO to NICE, to get the arrangements consistently applied. On 11 February, the Minister for Crime Reduction, Policing, and Community Safety, then the Under-Secretary of State for Health, confirmed in a parliamentary answer to me that that was under consideration.
During that period, I conducted my own survey of health trusts. Some 30 per cent. said that funding was the biggest hurdle to prescribing EPO and that it would 238WH be beneficial to have an early reference of the drug to NICE. The then Minister also reaffirmed that that was being considered in the ninth wave of work that NICE would undertake.
There has been no certainty in the community since the earlier debates, so I conducted my own survey of cancer networks to find out how the uncertainty was affecting them on the ground. I do not mean this to be pejorative, but the replies that I received were that it was rather disingenuous to suggest that there were no funding barriers. The current situation with EPO is that it is a non-NICE approved product, whereas a NICE-approved product would have considerable funding weight. There are barriers to funding if a product has not been approved.
That led me to look further into the costs, and I did some analysis and put some information to the Treasury and others about the relative economics of blood versus alternative treatments. I tried to contribute to that part of the debate, but it came out clearly that NICE is the vehicle for doing a total cost analysis of one treatment versus another. The national health service and health economists do not seem to be able to introduce a proper, consistent process for which funding follows.
I have given information to the Treasury, which seems to think that it would be a good idea to assess the treatment. The industry that produced the product thinks that it is a good idea, and the medical profession seems to think so as well. Patient groups and charities tell me that it is a good idea. According to the latest information, a joint planning group of officers from the Department of Health and NICE are to consider whether assessment should go forward. I ask myself, therefore, exactly what it takes for something to get on the list for appraisal and to be included in the programme of work, given such a body of evidence. I am still waiting for confirmation that that particular treatment will be considered in the ninth wave of NICE's work. I have written to the Minister and ask her again today to give assurances that that will happen.
As well as issues about how something is selected, there are questions about what happens after the reviews are done. The reviews of reviews are taking place at present, in that the WHO is examining the way in which NICE does its work, and NICE is re-evaluating its own appraisal processes, but there are questions about what happens after reviews are done.
Let me give some examples. I am particularly concerned about the speed at which the process works. The first example is the one that I have already given of EPO. If it were to be included in the next programme of work, the evaluation would start later this year. The evaluation—approval, recommendations, promulgation and so on—would take 12 months. By the time funding was in place in the health service, it would be 2005. The process takes that long. Ten years after a product is licensed for use, it gets NICE approval and, possibly, funding.
I try to imagine what would happen if tomorrow I came up with a bright idea and a cure for the common cold. If it were referred to the evaluation process, it would be at least two years before it was applied in the national health service. The general public would think that bizarre.
239WH What happens if a product goes through the process and is approved? I am happy about the confirmation that, within three months of approval, funding should be made available by the commissioning authority, whether it is a local health board in Wales or a primary care trust in England.
However, there are exceptions. One of the latest reports deals with insulin pumps. It took two years for that treatment to be selected. It then took a year for it to go through the process that I have just described. Within three months it should have come into application, but it has not. Implementation has been delayed because of problems with acquiring the technology and with training people to use it properly. There are post-appraisal effects that require serious examination.
There are other effects. For example, the Government are laying themselves open to charges of anti-competitive practices. If the reverse of the situation that I described earlier occurs and EPO is approved and gets funding, the truth of the matter is that it gets funding over and above something else. The Government know that they need to be careful in that area. There are classes of things that are already approved. I want to know how something being approved, or not being approved, fits with articles 81 and 82 of the EC treaty and the Competition Act 1998.
We need a process that allows a review of classes of treatment, because technology is moving so quickly that even though we can protect ourselves against a charge now, within months we are open to that charge again. There needs to be an interim guidance process, because there will be a sound clinical and evidential base for those things to happen.
I understand that the whole point about NICE is that it provides a clear, well-established evidential base to make changes, and I support that, but we are talking about incremental change over time. We need a process to deal with the interim period and re-evaluations. With peer reviews, licensing and so on, there would be enough evidence to provide processes by which an interim guidance procedure could be introduced. Otherwise, the Department opens itself up to charges of being anti-competitive, as well as of not necessarily keeping pace with the best developments for patients. I want to know whether there is any thought of issuing that sort of guidance and, if not, why it cannot be issued.
On change, we are talking about ways of deciding what is the best thing to do, and about doing away with the old processes and introducing better, new processes. NICE is, first of all, about making consolidated incremental change. However, we need ways of dealing with step change. I have made that point time and again in relation to other areas. Without that, we lack consistency of application.
I want to comment on postcode prescribing, because the issue is even more extended than that. As a Member of Parliament from Wales, I want to consider the devolved environment. Although NICE covers England and Wales, Wales has the All Wales Medicines Strategy Group and Scotland has the Scottish Medicines Consortium. Those bodies do similar things to NICE, but they can do assessments within three months. The disparity in the speed of application in different parts of the United Kingdom needs to be considered.
240WH The Select Committee rightly dealt with the idea that quality of life should take precedence, or have a high priority, in all the assessments. Everything that I have said until now tends to suggest a technical view of the world as a place that is evidentially based in terms of technology, regimes and epidemiological studies, but, within that, there is another aspect: the quality of people's lives. if we are to do something about that, we need to do things better and quicker.
To do that, NICE needs more resources. It is all very well for me to claim that it should do things more quickly, and to a better standard, but the reverse of that point is to ask what resources it has to do that. What, if any, additional funding and resources will be given to NICE to appraise more treatments more quickly?
I have covered three areas. I would like confirmation that EPO is being referred to NICE for appraisal. I would like some understanding that interim guidance could be introduced to keep pace with technological change and avoid restrictive practices, and I would like to know that additional resources are to be given to NICE to allow it to appraise more treatments more quickly.

§ The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson)
I congratulate my hon. Friend the Member for Merthyr Tydfil and Rhymney (Mr. Havard) on securing the debate and on his interest in a subject that I know he has pursued vigorously for some time. When we came to office in 1997, we inherited a national health service with an absence of national standards. There was no means of spreading good practice or of eliminating bad practice. There was no process for developing national guidance on the use of new treatments, and no independent inspection of local services. The health service was starved of the investment that it needed to meet the legitimate expectations of patients.
Since coming to power, we have established a clear national framework within which local NHS services can operate. We have developed new national standards for cancer, mental health, care of the elderly and coronary heart disease, and others are in the process of being developed. We have introduced a new duty of quality, and a new system of clinical governance to drive up standards of care across the NHS.
Central to our modernisation programme is the National Institute for Clinical Excellence, which we established to give clear national guidance on the use of drugs and other treatments. Its work reaches into all aspects of the NHS, from wider judgments on whether a new treatment is both clinically and cost effective, to assessments of what care is best for individual patients.
My hon. Friend recognises that NICE forms part of our plan to give us a world-class health service. I am grateful for his supportive comments. NICE was established in February 1999. As my hon. Friend said, it has a clear range of objectives. He supports the way in which it works for common standards, the fact that it seeks to promote a faster uptake of treatments, and the fact that it wants to ensure that resources are used more effectively by focusing on the treatments that work best for patients.
My hon. Friend has done much research on the Erythropoetia treatment that concerns him, and I understand the benefits that he believes cancer patients 241WH will receive. I also recognise the knock-on effects on the future supply of blood, and for the NHS more generally through the potential saving in bed days that he described. He made a strong case, but that is only side of the argument. Some argue that EPO may be useful in only a minority of cancer cases and that it is simply not effective enough to be used as a standard treatment in the majority of cases. Some would further argue that the savings in bed days might not be quite as high as estimates suggest, because cancer patients need to be seen in hospital regularly, and blood transfusions may be one of several procedures required in a single visit. The beds will be needed not only for transfusion. The cost of treatment with EPO is likely to be more than the cost of the blood used in transfusions.
I do not want to get involved in those arguments today, however, because I am neutral on the matter. We have said that it is for NICE to consider it, and NICE is the most appropriate forum to consider the use of EPO versus blood transfusions. NICE has the responsibility and, most importantly, the expertise to consider the wealth of evidence collected by my hon. Friend, and it can provide independent and authoritative advice.

§ Mr. Havard
My question is whether consideration of EPO will be part of the ninth wave of NICE. I do not contest that it is the appropriate body to examine such incremental changes.

§ Miss Johnson
I shall come to that point next, as my hon. Friend has raised it. Work on developing the ninth wave of NICE's work programme is complete. Ministers are considering the items to be included in that wave, and an announcement will be made shortly. I am sure that my hon. Friend will understand that I am not in a position to make that announcement today. The remit, or terms of reference for each study, is made public when the ninth wave goes out for consultation, as happens with each wave. When NICE receives its work programme, it determines the timing of topics within each wave, taking account of such issues as the licensing of important new drugs and clinical need. Again, I believe that my hon. Friend comes from the same position as I do on this, in that he argues strongly that NICE is the right mechanism for determining such matters.
NICE determines who should be consulted during the study and draws up a list of stakeholders. My hon. Friend supported the arrangements for engaging and participating with patients and other key stakeholders as part of the work that is done. NICE carries out as part of its work an investigation of both the clinical effectiveness and the cost effectiveness of particular drugs and treatments. My hon. Friend will therefore have to await announcements in the fullness of time to learn what is included in the ninth wave.
We have made drugs that treat cancer a priority. My hon. Friend mentioned the postcode lottery for chemotherapy drugs, which we are concerned about. By implementing NICE appraisals on chemotherapy drugs for ovarian, brain, pancreatic, lung and breast cancers, as well as leukaemia and lymphoma, we are tackling the problem of the postcode prescribing lottery that he mentioned. Some 31,000 patients a year are eligible to 242WH benefit from those drugs; EPO, which is primarily a therapeutic drug is currently being considered for referral, as he knows. I agree that quality of life is also important in such circumstances, although treatment for cancer is clearly a high priority, and sometimes such things will have to be weighed against each other.
On NICE's capacity, we obviously cannot send everything to the institute at once. NICE is already considering a growing number of cancer technologies. The rate of innovation in cancer research means that there are always many topics for potential referral. That is a good thing in many ways, although it obviously has its downside. It would not be right to fast-track EPO, a primarily therapeutic drug, ahead of drugs that treat and potentially cure patients. We must decide where and when NICE can best add value. EPO must go through the normal channels, but I am optimistic that it will be referred to NICE.
In response to my hon. Friend's questions about competition, I should say that there are no competition issues to address in that context. He mentioned three months, which is sufficient for the majority of NICE's guidance. The NHS should gear up to establish robust arrangements, if it has not already done so, to release funds when required. In any event, we are prepared to issue bespoke directions if, following consultation, NICE advises that implementation over a longer period is desirable. Such matters will always be watched over carefully, and it is appropriate that they should be, because they are matters on which both patients and clinicians have a keen interest. It is therefore appropriate that there will be ongoing discussions and consideration of how well the arrangements are working. However, we have certainly put in place arrangements to make such things work as well as they can.
As I understand the matter, there are no plans to extend the funding of NICE beyond current plans. My hon. Friend will understand that it is resourced to do the job, and that there will always be a balancing act between the resources we direct to any such special health authority and the money that is spent directly on patients. We set up NICE to tackle postcode prescribing and inequality, and it is central to our plans to modernise the NHS and drive up standards. NICE has issued 41 guidelines and 44 technical appraisals, which are in simultaneous preparation, making it the largest programme in any country. That is an impressive record. In the first four years, NICE published 62 appraisals, which gave advice on pharmaceuticals, surgical procedures, diagnostics and medical devices.
I understand my hon. Friend's interest in the subject, which he has pursued with his usual vigour. From what he said today, I am sure that he will await the announcement of the ninth wave with great interest. I hope that what I have said recognises sufficiently the interest that he has shown in the matter, and the way in which he has advanced his case and brought to our attention evidence about the issues surrounding the therapeutic treatment in question. We place our faith in NICE to deal with such matters through appropriate processes, which I am sure my hon. Friend fully supports.