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I wish to touch on the points that very learned hon. Members have made, and also on NICE. I know that there is going to be a debate about NICE in the near future, but we cannot do justice to this debate without considering it, or without considering how the funding formula in the NHS works, particularly in England.

I have looked at a Library paper setting out figures for exceptional circumstances appeals in the hon. Gentleman’s constituency. Some 57 per cent. won their appeal, and 31 per cent. lost. I do not know what happened to the other 22 per cent.—I have not had the opportunity to ask the Library whether they are just sitting out there in limbo—but there is obviously a problem. Those figures relate to people’s lives. I do not think that the Minister and I will disagree about much in the debate, because we care passionately about getting things right.

In the constituency of the hon. Member for Norwich, North, 31 per cent. of those who were told that they needed a drug or treatment and appealed under the exceptional circumstances rule were declined. Many of those patients and their families will have known that, in another part of the country, they may well have had their treatment funded. That is right at the heart of the problem. The hon. Member for Southport (Dr. Pugh) was right that it is impossible to fund every treatment that experts come up with, and that the NHS has rationed treatment for the past 60 years since its inception. However, patients and their loved ones deserve as much open and honest information as possible about why they are likely to need treatment, why they will not get it and, as was said earlier, whether the treatment will work.

That is why I was worried by what the hon. Member for Wyre Forest (Dr. Taylor) said. He has generations of experience in the medical profession—probably longer than I have been alive. Having sat with him on the Select Committee on Health for two and a half years, I know that his knowledge is invaluable to the Committee. He said that the document that he had got from an SHA was—I shall use my language rather than his, which was much more generous—complete gobbledegook. He said that not only did he not understand the letter, but that nor would the patient, and probably none of the consultants who have seen it.

We are moving towards having drugs specially prescribed for a patient with a particular genetic footprint. How will a patient have faith in a consultant telling them, “This drug is no good for you, because you do not have the genetic footprint for it”, if we cannot even get the basics of an appeals procedure into language that is common to us all. The hon. Member for Norwich, North, mentioned the diversity of his community and the number of different languages that are spoken, but here we are dealing with only one language, English, and even a retired senior consultant with years of experience could not communicate to his constituents what the SHA meant.

I was also concerned by what my hon. Friend the Member for Wellingborough (Mr. Bone) said. He is a doughty fighter for his constituents, and I congratulate him. How can we explain to anybody that they or their loved one will not get a drug that may well help them, because they are on the wrong side of an arbitrary
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border? I know that the Government are examining the funding formula as a result of the Health Committee’s excellent report on the funding and deficits of the NHS. As the Minister knows, I am sceptical about how we have suddenly leaped into a wonderful period of surplus in the NHS.

Mr. Bone: My hon. Friend is laying out the arguments clearly. Before he moves away from formulae, I wish to say that the national capitation formula is worked out at great expense and is used to decide how much each PCT should get. Every year since that formula was introduced, my PCT has received less than 100 per cent. How can that possibly be fair? The Government cannot even fund their own formula.

Mike Penning: My hon. Friend has raised the core issue that the Select Committee, a Labour-dominated Committee, examined. We had grave concerns about how a formula that has cost huge amounts of money to decide could be so fundamentally flawed. My constituency is not a long way from his, and during the Committee’s proceedings I asked the then Secretary of State why her constituents would get some £400 a head more than mine each year, which was causing extensive rationing, cuts and closures in my constituency. She simply said, “Your constituents are more healthy than mine, which is why you get less money”. I think that the hon. Member for Wyre Forest was present at that evidence session.

I cannot say strongly enough that there is a dire need to address the anomalies in the funding formula. In my opinion and that of my party, many of the anomalies exist because there is not enough attention allocated to the age profiling of the particular area. Naturally enough, where there is social deprivation and there are early deaths because of that deprivation, we need to work on the public health side of matters. At the same time, however, if there is an ageing population in a constituency—the particular disease that my hon. Friend the Member for Wellingborough referred to is age-related—that constituency is penalised, because people are living longer, which is when that disease affects them; that is the situation in his constituency.

My right hon. Friend the Member for West Dorset (Mr. Letwin), who I am sure has gone to carry out very important duties elsewhere, talked about joined-up government and we would all like to see more of that. It is very difficult for NICE to make decisions without the knowledge of how those decisions will affect the community as a whole.

I would now like to look carefully at some ideas for NICE, and my party would be very happy if the Government took them up before the election, whenever that comes; I say all this completely in good faith. Often the problem with NICE is that, by the time it starts to look at a drug, that drug is a long way down the line. Perhaps lots of articles have already appeared in the press or consultants have talked about it, but NICE’s assessment has not taken place early enough. It is very important that NICE starts to assess new drugs and treatments during the drug licensing process, so that it communicates much earlier with the drug companies and it knows what drugs are coming down the line. Therefore, it can start its assessment while the licensing process takes place. At the present time, the assessment takes place after the licensing process. Obviously, that situation applies not just to drugs but to treatments.

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It is important that NICE is an independent body and that it is autonomous. However, it must also be set out as an autonomous body, and as one that is accountable. Perhaps we need a Bill before Parliament to give it that statutory role. At the moment, it has a special health authority role rather than a statutory role.

Earlier on, several colleagues alluded to the issue of the QALY, the quality adjusted life year. Colleagues, we must think of another title for this measurement; we are talking about people’s lives here. It is imperative that we not only look at the term “quality adjusted life”, but that we look at what it actually means and whether it will give quality of life. On the Health Committee, we always looked at the top figure; how much is a life worth? It is much more detailed than a QALY would suggest.

NICE must also look much more at producing evidence-based commissioning guidelines. It must be much more involved with the whole process whereby evidence is given to different PCTs around the country.

Finally, I return to where I started, which is that we must not get away from the fact that this issue is about people, lives, futures and relationships with loved ones. The system is struggling to cope. I think that we would all agree with that; it is why we are debating this issue today. All too often my constituents come to me and say, “I have been denied this”, or “My loved one has been denied that”. People expect an openness and a frankness about decisions that are made which sadly, in many PCTs around the country, are not there.

I say to the Minister that, if the Government want to pick up on anything that I have said today, particularly on NICE, we would support them on that. We would also very much support the Government on establishing a much better practice within the PCTs around the country as to how they deal with these exceptional circumstances. I do not think that it is acceptable for a PCT not to have an appeals procedure, but some PCTs still do not have one. I do not think that that is acceptable in society today and certainly people should be able to appeal after they have applied.

12.13 pm

The Minister of State, Department of Health (Mr. Ben Bradshaw): I start by congratulating my hon. Friend the Member for Norwich, North (Dr. Gibson) on securing this debate; Norwich is my home city. I also apologise that the Under-Secretary of State for Health, my hon. Friend the Member for Brentford and Isleworth (Ann Keen), who is the Minister responsible for this policy area, cannot be here to respond. She is away on departmental business.

My hon. Friend the Member for Norwich, North and other hon. Members have raised a number of specific points about how the local health service across England manages and considers exceptional cases for cancer drugs. I hope to respond to as many of those issues as possible today.

Let me start by trying to define “exceptional cases”. They are cases where a primary care trust considers whether or not to fund a treatment where NICE has either not issued an appraisal or not recommended the treatment in its appraisal. It is worth remembering that, before the establishment of the National Institute for Health and Clinical Excellence, guidance on new drugs
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and treatments was being issued by numerous bodies at national, regional and local levels. Those bodies had very different ways of appraising evidence and developing recommendations. The status and implications of the guidance produced were not clear. That was confusing for doctors, who wanted to know what care they should be expected to give, and for patients, who wanted to know what care to expect.

That lack of coherent guidance led to big variations in prescribing practices across the country. It is precisely because of the complexities of modern treatment opportunities and also the need to ensure equity, clinical effectiveness and value for money for NHS patients that this Government established NICE as an independent body in 1999.

NICE is responsible for producing guidance for the NHS on the clinical effectiveness and cost-effectiveness of new and existing treatments, and it has become widely recognised as a world leader in its field. As I think my hon. Friend the Member for Norwich, North acknowledged in his speech, any taxation-based health care system will sometimes need to take difficult decisions on what to fund.

NICE’s guidance is based on a thorough assessment of the best available evidence and is developed through wide consultation with interested parties, including the drug manufacturers, patient groups and the NHS itself. Its appraisal and clinical guideline programmes have been both assessed and commended by the World Health Organisation.

As part of its technology appraisal process, NICE calculates the cost per quality-adjusted life year—if the hon. Member for Hemel Hempstead (Mike Penning) has any suggestions for a better name for that measurement, or a better means of assessing appraisals, I am sure that NICE would be very pleased to hear from him—to assess both the health gain arising from a particular treatment and the cost of that treatment.

Mike Penning: I was not talking about how NICE comes to its conclusions; I was talking instead about the need to perhaps have more sensitive language, rather than language such as “QALY”.

Mr. Bradshaw: Again, I am sure that NICE would be grateful for any constructive suggestions in that regard.

NICE does not operate a fixed threshold for the approval of a treatment but uses a broad range, to enable it to consider a broad range of evidence. The chair of NICE often refers to NICE’s use of the quality-adjusted life year as a “tool not a rule”.

NICE is currently carrying out a scheduled review of two of its key documents that provide a framework for its technology appraisals. These are the “Guide to the Methods of Technology Appraisal” and “Social Value Judgements: principles for the development of NICE guidance”. These documents cover a range of important issues, such as NICE’s use of QALYs and its consideration of orphan drugs, which I will come on to in a moment and which my hon. Friend mainly concentrated on in his speech. Draft documents have recently been subject to a full public consultation and NICE is considering all the comments that it has received.

Clearly, as hon. Members have said, it is vital that when NICE issues guidance, it is implemented consistently across the country and the Government have a role in facilitating that implementation. Provision for NICE
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guidance is made in funding allocations to PCTs, and NICE’s technology appraisal guidance is supported by a funding direction that requires NHS commissioners to make funding available for NICE-recommended drugs within three months of guidance being issued. These measures ensure that NHS clinicians across the country should be able to prescribe any treatment recommended by NICE. NICE guidance does not override the clinician’s responsibility for individual patients, but we expect NHS doctors to take NICE guidance fully into account in their decision making.

Compliance with NICE’s technology appraisals is now a core standard against which NHS organisations are judged. NHS organisations are required to demonstrate for the annual health checks that they are providing funding for NICE-recommended treatments within three months of guidance being issued.

Mr. Bone: There is an important point to be made here. I think that the Minister is saying that, once NICE has reached a decision, it is three months until implementation of that decision. However, there is of course the whole procedure where NICE gathers evidence, then the matter goes out to consultation and there is a three-month period. What does he think that PCTs should be doing in that period?

Mr. Bradshaw: I will come on to that subject in a moment, if I may.

Where an NHS organisation fails to comply with NICE’s technology appraisal guidance, it is the responsibility of the strategic health authority in the first instance to support any of its organisations to achieve the necessary improvement. My Department has made it absolutely clear that if evidence comes to light that a particular body is failing to comply with the statutory funding direction to put in place funding for NICE technology appraisals within three months, it would expect the relevant strategic health authority to ensure that action is taken. If any hon. Member in this Chamber or elsewhere in the House has examples of where that is happening, I would be happy to draw them to the attention of the relevant SHA.

Dr. Pugh: Will the Minister give way?

Mr. Bradshaw: No, I must make progress. I have to get through many responses.

Trusts are monitored against the core standards by the independent Healthcare Commission in its annual health checks, and each NHS organisation’s rating is published. In 2006-07, 89 per cent. of NHS organisations were compliant with the standard relating to the implementation of NICE’S technology appraisals. That was a 5 per cent. improvement over the previous year.

A report issued in 2006 by the national cancer director, Mike Richards, showed a continued increase in the uptake of new cancer drugs by the NHS following positive NICE appraisal. It also confirmed a reduction in the variation around the country of the use of such drugs. That was partly due to the big increase in spending on cancer drugs—£729 million in 2006—which is expected to grow by between £60 million and £80 million a year for the next few years.

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The improvement in implementation shown by Mike Richards’s reports can be attributed to several factors. In addition to the comparative data presented in the reports themselves, the period also saw the establishment of NICE’s implementation directorate and the introduction of the Healthcare Commission’s independent assessment. Professor Richards will repeat his evaluation of NICE-approved cancer drugs during 2008 to ensure that patients across the country continue to have access to such treatments. The evaluation will assess the period July to December 2007 and is expected to be published by the end of the year.

Where NICE guidance does not exist, either because it has not yet been developed, as in the case of the renal cancer drug referred to by the hon. Member for Wyre Forest (Dr. Taylor)—incidentally, the letter that he read out is a good example of why a plain English campaign is needed in the health service—or because it is not part of NICE’s work programme, it is for PCTs to make decisions based on the evidence that is available on whether to fund the drugs locally.

Such decisions are not new to PCTs. The principle of some local autonomy in decision making is supported by all parties in the House. It is important, as the PCTs are usually best placed to determine and meet the health needs of their population and to know more about the exceptional needs of individual patients.

Concerns have been raised about the speed between drugs being licensed and NICE appraisals being finalised, and the different decisions that might be made by PCTs around the country during that time. Four actions have been taken to try to address that. First, NICE introduced a new fast-track process so that for certain treatments it can provide guidance within weeks of a drug’s being licensed. That process was used for the appraisal of Herceptin.

Secondly, we issued management guidance to NHS organisations in December 2006 reiterating the message that decisions on funding for individual treatments should be made on the basis of the available evidence. The guidance makes it clear that it is not acceptable to refuse to fund a treatment solely because NICE guidance does not exist. It also pointed PCTs to useful sources of information to help them in reaching their decisions.

Thirdly, the cancer reform strategy, which was published in December 2007, set out several sources of information that PCTs should consider as a minimum when making decisions on treatments not yet appraised by NICE. Finally, the strategy also proposed a default position that all new cancer drugs will be referred to NICE for appraisal if there is sufficient evidence and a large enough patient population to justify doing so.

My hon. Friend the Member for Norwich, North raised a couple of specific issues. He discussed the problem that he had encountered in respect of transparency and the democratic deficit in decision making by PCTs. He has a point. It is general good practice for PCTs to be open and transparent about their processes. Indeed, my noble Friend Lord Darzi will address the whole issue of democratic accountability of PCTs when he publishes the final report on his review of the health service later this summer.

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