Westminster Hall
Thursday 8 May 2008
[Mr. Roger Gale in the Chair]
National Institute for Health and Clinical Excellence
[Relevant Documents: First Report from the Health Committee, Session 2007-08, HC 27, and the Government’s response, Cm 7331.]
Motion made, and Question proposed, That the sitting be now adjourned.—[Liz Blackman.]
2.30 pm
Mr. Kevin Barron (Rother Valley) (Lab): To preface the debate, I thank the secretariat of the Select Committee on Health, whose seven members have worked hard for us. I also thank our three advisers on the report—Professor Joe Collier, Professor Alan Maynard and Dr. Hilary Pickles—who gave us excellent advice.
The report took some time to gather. We had some 124 memorandums and 31 witnesses, and we visited Scotland, France and Canada—I am not sure whether it was in that order. On our visit to Canada to see similar organisations, their representatives spoke in glowing terms about the National Institute for Health and Clinical Excellence, saying not only that NICE co-operates well with Canada but that it is leading large areas of the world in assessment and the use of drugs in the health care system. I ought to put on record that NICE’s international co-operation does it and the United Kingdom proud.
I will make some general comments about the report—what we were considering, and what we found—and the Government’s response, and then I will probably pose a few questions that my right hon. Friend the Minister may wish to reply to, either during this debate or later. We examined the work of NICE. Members will know that NICE was established in 1999. We found that in the eight years since it was established, in response to internal and external review, NICE has shown itself ready to change. Initially, it appraised technologies, mainly medicines, and produced clinical guidelines. Its remit was soon expanded to cover interventional procedures. Subsequently, technology appraisals were made mandatory and the single technology appraisal was established to speed up the evaluation process. Since 2004, it has also examined public health issues. It is in no way an organisation that has been static since it was set up. Indeed, it has responded positively to many issues.
During our inquiry, we received a good deal of evidence that NICE is carrying out many of its functions effectively. However, NICE also has its critics, which is one of the reasons why we undertook the inquiry. We examined three main areas of relevant concern—the evaluation process, the affordability of guidance and implementation. In addition, after the Office of Fair Trading report on the pharmaceutical price regulation scheme, we decided to consider NICE’s potential role in such a new system, although I must say that at the time, I believed that if the PPRS were to be renegotiated and not removed, we would not necessarily have to spend much time on that. I will say something about that later.
We identified several problems with the evaluation process. The first is topic selection. Only a few selected medical technologies are chosen as suitable for assessment as technology appraisals. There is also far too little emphasis on disinvestment. I think that we trod on one or two toes when we commented on that in our report, but the Health Committee has previously considered NICE and commented on disinvestment. A few older treatments do no good at all, and many of them are not cost-effective. Because NICE selects what it assesses, we might be able to disinvest more than we do.
The wider benefits of treatment to society—for example, issues involving the cost of carers—are not included in NICE’s cost-benefit analyses. I could go on from there. We used the specific example of carers, but in taking evidence, we often asked questions about employment, and whether that would be taken into account in determining the cost-effectiveness of keeping somebody, maybe a family member, in work. It was a bit difficult, but we did not draw up a shopping list. There are probably wider issues that could also be taken into account.
NICE often does not have all the information that it needs to make a full assessment. It does not have access to all the information used by the Medicines and Healthcare products Regulatory Agency, and clinical trials are usually designed without NICE’s work on cost-effectiveness in mind. We made some specific recommendations on that point that have not gone down particularly well, and I may return to that later.
Experts are not used well. That is not a criticism of the experts involved in NICE. Members will remember that in challenges in the courts, clinicians who advise NICE have often been criticised by other clinicians. We thought that that was unfair, because it is a trap for someone advising NICE on a particular issue. We heard that criticism, which also came out in the media. Some of us have been to lobbies in this place and heard people say that the right people had not given NICE evidence during its assessment procedures. I have mentioned the names of three people who advised us on the report. They were with us all the time, and they helped us to gather witnesses and put the report together, but in the end, they took no part in the final decision. However, our advisers were constant. We wondered whether NICE ought to consider using experts in that way, instead of asking them to give an opinion as well.
Publication of guidance is slow. Licensed medicines are often not prescribed while primary care trusts and clinicians wait for NICE to make a decision. Again, some of the challenges involve that issue. The industry calls that NICE blight, because it takes so long for decisions to be made.
We made a number of recommendations to address the problems. Key among them was that a system is needed under which all medicines are assessed at launch. A shorter, less in-depth evaluation should be made between licensing authorisation and marketing, so that clinicians can prescribe useful and cost-effective drugs as soon as they are launched. A lower cost per quality adjusted life year threshold should be employed during early assessment to ensure that only the most cost-effective and clinically effective products are available straight away. A full appraisal should be made thereafter, so that the threshold can be increased, if that is warranted.
In order to ensure that NICE has the information that it needs, it should have access to the same material used by the licensing body, clinical trials should be registered and NICE and the pharmaceutical industry should work together more closely. That is particularly important to the effective assessment of drugs in time for launch. I recognise that that could involve major problems. Pharmaceutical companies are not all based here, and their way of doing research and development might not be easily read over, but discussions could be held with them to see whether some international consensus is possible, so that assessors—not only NICE but people doing the same job in other parts of the world—could use a measurable framework.
We recommended that more be done to encourage disinvestment. No evaluation of older, possibly cost-ineffective therapies has taken place to date, although two are under way. As I have mentioned, our predecessors on the Committee made the same recommendation. We would like to be convinced that NICE is moving a bit quicker.
In our last report on NICE, we also recommended that the legislation be changed to accommodate the need to ensure that assessments of products take account of the wider benefits to society. We have made that recommendation again. The affordability of NICE guidance and the threshold that NICE uses to decide whether a treatment is cost-effective are of serious concern. It has been in the headlines practically throughout NICE’s life. The threshold is not based on empirical research and is not directly related to the national health service budget. It seems to be higher than the threshold used by PCTs for treatment not assessed by NICE.
We heard from witnesses, including those from patients’ organisations and pharmaceutical companies, who thought that NICE should be more generous with its cost per quality threshold and approve more products. On the other hand, some PCTs struggle to implement NICE guidance at the current threshold, and other witnesses argued that a lower one should be used. We recommend that the threshold used by NICE in its full assessment should be reviewed. Further research comparing PCT thresholds with those used by NICE should also be undertaken. That is denied in the response, but we believe that we have found enough evidence—although perhaps not concrete evidence—that NICE uses levels that are different from some PCTs. We also believe that an independent body should determine the threshold used when making judgments on the value of technologies to the NHS. I shall return to that subject at the end of my opening remarks.
The implementation of non-mandatory guidance is variable, owing to a variety of causes, including the threshold used by NICE for determining cost-effectiveness, a lack of clarity about the status of guidance, a lack of involvement by PCTs in the development of guidance and disagreements between clinicians about the worth of some of NICE’s guidelines. I have no doubt that that has been the case for the eight years that NICE has existed. However, there is a glimmer of hope that people will start to concentrate on implementation a little more. NICE is not the only body that needs to act, and the entire health care community should take part as well. I do not know whether the Darzi review of the
NHS will consider that, but some of the Committees that Lord Darzi is using are obviously made up of clinicians. Lessons should be learned from that about ensuring that PCTs are engaged and have ownership of some of NICE’s procedures.
To improve the implementation of NICE guidance, we have recommended more help for PCTs, better assessment of the level of uptake, a larger role for PCTs in development, the better use of experts in development and a change in the terminology used by NICE to clarify to patients what they can expect by right from their local NHS organisation. We also recommend that elements of clinical guidelines be made mandatory. A suitable example is risk assessment for all patients at risk of developing venous thromboembolism.
Some of the problems with affordability and the implementation of NICE guidance relate to the price of medicines. As I have mentioned, the OFT recently recommended that a new system of value-based medicine prices replace the PPRS. We found support for that, but there were concerns about how it would work in practice. We understand that discussions between the Government and the pharmaceutical industry are under way, so our report makes no large-scale recommendations for the new scheme. However, we agree with the Government that better mechanisms are needed to ensure that the NHS pays a fair and affordable price for medicines. We also recommend that NICE should be involved in any new system and that any change to its remit should be adequately resourced. I shall ask a few questions about that at the end of my remarks, but I want to say now that although we did not consider that in great detail, we believe that NICE ought to assist in any major changes, if there are to be any.
We concluded that NICE does a vital job in difficult circumstances. The development of more and more health technologies and procedures, alongside rising patient expectations and the ageing population, will make it even more difficult in the future. Health care budgets in England, as in other countries, are limited. Patients cannot expect to receive every possible treatment, and demand outstrips resources and priorities have to be determined. In other words, rationing is essential, and NICE has a key role to play. In the past, NICE has changed in response to new challenges, and we are sure that it can do so again. Given the difficult environment, NICE requires the backing of the Government. It also needs Ministers to support it—not to seek to undermine it. It must not be left to fight a lone battle to support cost-effectiveness and clinical effectiveness in the NHS.
The Government’s response was generally supportive, certainly in tone, but it was non-committal about some of the details. Of course, much depends on the Government’s decision about the PPRS. The response to our recommendation about quality adjusted life years is not untypical:
“The government will consider with NICE the need for further research”.
That is fine, but we are unlikely to look again at the pharmaceutical industry or NICE in the near future. Furthermore, the Care Quality Commission will consider inspection of the implementation of NICE guidance. This morning, we actually interviewed the Government’s nominee to take over the chair of the CQC.
The Government rejected a number of our recommendations, such as the recommendation that a separate mechanism be put in place to advise on the
cost per quality adjusted life year range and that NICE be given the right to see all the evidence used by the Medicines and Healthcare products Regulatory Agency. The Government pointed out that several of the Committee’s recommendations are matters for NICE, including the use of experts, information for consultees and the use of implementation consultants. We accept that.
It was unusual and pleasing that NICE itself submitted a response to our report, for which I thank those responsible—I see that at least one of them is within earshot. We decided this morning that we will publish its response, in the same way that the Government publish their response—although, probably not with a crown on it. The NICE response accepts some of our recommendations, but stresses that it is already doing much that the Committee urged it to do. For example, on topic selection, it does not focus excessively on expensive drugs. Furthermore, it is looking at disinvestment, the issue of experts and information about processes to consultees. Like the Government, however, it also rejects a number of what we believe to be key recommendations, notably on early “rough and ready”—I think that that is what it called it—appraisal of all drugs at launch.
As I said, we visited Scotland and the Scottish Medicines Consortium—this is probably more a matter for the Department than for NICE. People often tell those of us who represent English constituencies about how quickly drugs are available in Scotland, as opposed to those appraised by NICE. We effectively, without mirroring it exactly, made recommendations that would introduce in England something not dissimilar to the system in Scotland. That recommendation was knocked back not only by those who responded statutorily to our report, but by the pharmaceutical industry itself. If the latter is listening, I say to it that we cannot have NICE blight here when everything is better in Scotland.
When we make recommendations that are not too dissimilar from what is happening in Scotland, we do not want the kind of response that we got from its trade body, which opposed the recommendation on the grounds that it looked “quick and dirty”—I think that those were the words that it used. Quite frankly, however, we can only do the assessments that we did, and the matter will probably need to be looked at further by the Government, the pharmaceutical industry and NICE, because something needs to be done. There is a constant clamour, not necessarily from the pharmaceutical industry, but from patient groups and constituents asking, “Why are we waiting so long for a drug that is available in Glasgow or Edinburgh?”
NICE also rejected our recommendation on the threshold. It suggests that its threshold is not out of line with those used by PCTs. I said earlier, “some PCTs”, but I still believe that we saw evidence for that in our inquiry. Recommendations 2 and 25 refer to NICE’s role and use the R-word—rationing. They deal with rationing arrangements and essentially ask the Government to work with NICE to make those arrangements clear to the public. In neither of her responses, does the Minister use the word “rationing”. Effectively, she has dodged the issue in this very big public debate. The Government’s response avoids using the word, and one or two members of the Committee—I will not look round—found it difficult to accept that we should use that word in the report and in the conclusion, but rationing is what NICE does.
Rationing has been around inside the national health service for nearly 60 years, and we all recognise that fact. It would be better if we were to have an open debate about rationing inside the national health service, instead of talking about “postcode prescribing.” Some people think, “If I moved across the road or down the way, I would be able to get this drug.” We should have an open and honest debate about why people contact us and say, “Why can I not have a drug in this particular PCT, but I can have one next door?” If we take on the issue, we will better serve the public. The Minister may ration her response when she speaks later, but I personally think that we should have such a debate.
In the response to recommendations 15 and 16, in which we asked for a more rapid and non-selective appraisal of all known drugs and for guidance on each drug to be made available at its launch, the Government said:
“The Government continues to work with NICE to ensure that the STA process works as it should.”
That is fine. I am very happy with that, but will the Minister tell us exactly what she means when she says that the Government will work with NICE in considering this area? Has she any specific ideas about what they will be looking at?
The Government’s position on NICE’s work on disinvestment is not too clear, but the Minister said that she was keen for NICE to give a high priority to that activity. In view of the history, I wonder whether there is a mechanism by which the Government can consider the question of disinvestment.
In recommendation 36, we asked for a separate independent body to review the threshold that NICE uses when it decides whether to make a medicine available to the NHS. Effectively, we wanted a one-off review of thresholds. We wanted to know how those thresholds fit with the NHS budget as a whole and with non-NICE-related purchasing decisions made by trusts, and to assess on what grounds the thresholds might vary. We believe very strongly in that proposal, but the Government dismissed it:
“The Government is not convinced that any potential benefits of establishing a separate mechanism of the kind envisaged by the committee outweigh the likely disadvantages.”
The recommendation may have been badly worded. It was not our intention to have a separate body for ever, but we wanted some independent tests of the thresholds. The question whether our constituents are being treated fairly by the national health service goes round and round in the media. If the Government do not think that there is a need for a standing mechanism to consider thresholds, could we assess them and get them independently tested, so that there is another voice in the debate?
In recommendation 30, we argued that there is public confusion about the status of the various types of advice published by NICE. The Government’s response says that they will
“consider further whether there is more appropriate terminology.”
The Government do not say that they disagree with us about the public confusion. If they do not disagree, then there must be some better terminology that we can use—that sounds a bit taut, so perhaps I will revisit that later. I say to my right hon. Friend the Minister that unless the Government say that there is no public confusion, there must be something there. We think that the public would be better served by better terminology.
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