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Sandra Gidley (Romsey) (LD): It is fair to point out in my opening remarks that the Committee has looked at the National Institute for Health and Clinical Excellence in the past. We first looked at it in 2001-02, and the atmosphere of this inquiry was very different. Going back six or seven years, Mr. David Hinchliffe, the then Chairman of the Select Committee, commented that there had never been so much positive interest in an inquiry, or so many stakeholders writing to say how wonderful an organisation was. To be fair, many of the recommendations that we made then have been acted on, so this inquiry was set against a much more positive background.
The simple truth is that any organisation that is perceived as denying treatment to patients will be controversial. The other general simple truth, which has been alluded to, is that there is not an unlimited pot of money. Politicians need a trusted body to make decisions on cost-effectiveness.
The hon. Member for Basingstoke (Mrs. Miller) said that it was right that such decisions were made by clinicians. I would not want to rearrange her diary, but she might find it interesting to sit in on a NICE appraisal. When I didI am not allowed to say too much about itone thing that surprised me was that many of the people sitting around the committee were not clinicians. They were finance people from primary care trusts and chief executives of strategic health authoritiesthat sort of person. The balance is more heavily weighted than many people think towards financial considerations. There are, of course, clinical considerations, and experts give evidence, but the background of the speakers was obvious because of the nature of the questions that were asked. The exercise was fascinating. I understand that NICE might open up to the public even more, and that would be only to the greater benefit.
The Committees inquiry was prompted by issues surrounding Herceptin, and Alzheimers drugs had received a great deal of public and political attention. The only unfortunate aspect of our inquiry was that we were not allowed to raise any issues relating to the Alzheimers drugs, which were involved in an ongoing court case.
The Chairman highlighted the fact that social care costs are perceived as not being fully factored in. That was very much the argument that was raised at length when beta interferon was making its somewhat rocky
passage through the process in the early days of NICE. The Committee made certain recommendations about quality adjusted life years, or QALYs, and suggested that perhaps the wider cost to society should be factored in. The Governments response to that was interesting. They stated:
The suggestion that NICE take into account wider costs and benefits has instinctive appeal, but closer examination reveals a number of complexities and potential perverse effects which warrant further exploration.
For example, attaching a greater weight to impacts on economic productivity would have the effect of prioritising interventions for adults of working age, effectively deprioritising interventions for older people or for people who are too ill to return to work even with treatment. The impact on the consistency, manageability and timeliness of NICEs appraisal process also needs to be considered.
Deprioritising interventions for older people was precisely what those who were lobbying for the take-up of the Alzheimers drugs were suggesting was happening. One problem was that there was not complete clarity about the model. It is good that there will be discussions to explore the matter further, but the fundamental problem appears to be the lack of complete clarity.
NICE could complain that it is transparent, and that the information that it provides would give a company, or whoever was looking into the costings, the ability to work out how it arrived at its figures, but many people have commented that they do not have access to the precise financial model. Conspiracy theories abound as to why that could be the case. The most popular seems to be that if drug companies understood the system completely, they would learn how to manipulate it.
That might be a little unfair, but many patient groups feel that they are treated unfairly and that wider benefits are not fully taken into account. It would help the public accept some of the decisions more readily if they were reassured that such factors had been taken into account. The then Minister of State, Department of Health, who is now Secretary of State for Culture, Media and Sport, came before us at the time and said that he was satisfied with the situation. Sadly, such is the reputation of politicians that the public do not regard that as quite enough evidence.
That aspect came up again yesterday when I was at a reception that was hosted partly by the Royal National Institute for Deaf People. NICE is looking into cochlear implants. One of the concerns raisedit might be a false concernwas that while there would be savings for the education system because children with cochlear implants could engage in mainstream schooling, that might not be fully factored into the equation. It is clear that a one-size-fits-all solution is difficult to arrive at when examining wider impacts.
The calculation of QALYs appears, to some eyes at least, to be an art rather than a science. A practical example is that when we visited the Scottish Medicines Consortium, we were presented with a list of recently approved drugs, each of which had a cost per QALY at the side. At that time, I was interested in Lucentis, which is used to treat age-related macular degeneration. The cost per QALY that the SMC had arrived at was considerably less than the figure that NICE was bandying around in its appraisals at that time. The good news is
that many of the costings have been reviewed and the drug has now been approved, but why was the SMC able to come up with a figure that was about a third of the price that NICE arrived at? Unfortunately, when such examples get into the public domain, they undermine confidence in what is generally a good process.
Scotland has been mentioned a few times. It is worth saying that although we always read stories about drugs being available in Scotland but not here in England, the SMC told us that it had occasionally turned down drugs that were available in England. Surprisingly, we do not read about such cases the Daily Mail. Perhaps it would help to have more clarity on that issue, but I am not sure whose job it is to provide such clarity.
There seems to be a slightly more collaborative approach in Scotland. If there is disagreement about a companys figures, the parties get together to discuss it. NICEs procedures seem to be rather more formal and a little distant. If NICE disagrees with a company, it is up to the company to come back to it, so there does not seem to be such an active dialogue. There is a place for such discussions in the process of reaching understanding and agreement.
I agree with the hon. Member for Dartford (Dr. Stoate) that baseline QALYs have not changed much in eight years, as they have not been inflation-proofed. Seven years ago, we were talking about a threshold of about £30,000, and we are still talking about the same amount.
We made strong recommendations on the thorny issue of implementation in our report. Some improvements have been made, but there is still a problem. Let me give a local example. I received letters from a number of patients at the same time about a drug that benefits arthritis sufferers. They had been put up to writing the letters by their consultant, and they told me that they could not get the drug, which had been approved by NICE and should have been available. I did what any MP would do and wrote to the PCT, which told me that it was funding the drug. However, it was funding only six of that consultants patients, and the consultant had a dozen patients who could benefit from it.
In despair, I wrote to the Department, which said, Its nothing to do with us. It is up to the PCT, but the SHA is supposed to be performance-managing them. It was only after I wrote to Sir Ian Carruthers, who was quite good at working out such matters, and pointed out that the PCT could not possibly be providing enough funding to meet full demands for the drug, and that it was disingenuous of it to say that it was, that more funding suddenly became available. Similar games are being played with patients lives all over the country. Not every patient will write to their MP, and not every consultant will encourage a number of their patients to write to their MP.
conduct more in-depth inspections.
I was disappointed that the Governments response kicked that recommendation into the long grass. It said that it would ask the Care Quality Commission to reflect on the Committees recommendation, but the commission is only just getting around to appointing its chair and will have other priorities. It is not set up yet.
In the first year of its operation it will have a hard job melding the Commission for Social Care Inspection, the Healthcare Commission and the Mental Health Act Commission together. The implementation of NICE guidance will not be foremost on its list of priorities. I am concerned that the recommendation will be kicked into the long grass and that it will be three or four years before there is any action. In the meantime, patients are being deprived of drugs.
Mr. Barron: When we took evidence from the would-be chair of the CQC in this mornings public session, we heard that people in the Healthcare Commission are likely to be doing the same jobs for years to come.
Sandra Gidley: Yes, but the matter is not being dealt with at the moment. The CQC will have enough problems trying to meld organisations together and to carry on with its day job without taking on any new responsibilities. The formation of the new body will effectively mean that the recommendation dies. That is a shame, because NICE supported the recommendation in its response to the Committee. It must be frustrating to work for an organisation that does the work and makes the recommendations but does not see patients benefiting from that. It then gets all the flak when it makes a recommendation that is a bit more controversial. We should help with that.
I completely support the comments of the hon. Member for Wyre Forest (Dr. Taylor) about disinvestment. However, we have heard evidence that the matter is not as straightforward as might be assumed and that not so many issues can be considered. He made a good point, but what he suggested would not be easy to achieve.
Risk sharing has not been mentioned and the issue is fairly opaque. We took evidence from Professor Nicholl, from the University of Sheffield, who was involved in writing a report on assessing the multiple sclerosis risk-sharing scheme. The Sheffield researchers wrote the report over three years, and it was submitted last year. Interestingly, the next seven years of the contract then went to tender, and Sheffield decided not to bid. More worryingly, details of the scheme have not been publicised. The report is still not in the public domain and there are indications that the study will not yield reliable information about the beneficial effects of the drugs involved. Will the Minister tell us when the report will be available and how the Government intend to move forward on various risk-sharing schemes?
In conclusion, we all signed up in the report to the idea that NICE does a good job in difficult circumstances, but what we have heard today indicates that it could probably do so quicker and that implementation could be better. Those problems are not necessarily with NICE, however, and might be with the systems that surround it.
Mark Simmonds (Boston and Skegness) (Con):
First, may I say what a pleasure it is to have you in the Chair, Mr. Gale? I thank hon. Members, the Clerk and the advisers to the Select Committee who were involved in this extremely good and detailed report. I congratulate the right hon. Member for Rother Valley (Mr. Barron) on his detailed and eloquent introduction to the debate and summary of the issues. Every time I hear him discuss the NHS, I am more impressed by his detailed
knowledge of the topics that he is elucidating and by the articulate way in which he states his forthright and frank views.
The right hon. Gentleman was right to highlight the three key areas of the reportthe evaluation process, affordability and the pharmaceutical price regulation scheme. I shall return to the first two areas later. I was interested by the Ministers intervention on the right hon. Gentleman. I am sure that she will acknowledge that the pharmaceutical industry plays a significant role in the UK economy. It should be the view of every Member of the House, irrespective of party political persuasion, that it should continue to play that role. The right hon. Lady will be aware of the industrys concern about the way in which the Government have handled the renegotiation of the PPRSalthough I use the word negotiation loosely. The industry is nervous about a future in which the Government can be seen to break what industry believes was an initial five-year contract. The Conservatives support the move to value-based pricing, but believe that it should be done over a period of time and in consultation with the pharmaceutical industry. In the discussions that I have had, the industry has supported that approach. Page 3 of the Governments response to recommendations 15 and 16 of the report states:
The Government is currently seeking to renegotiate the PPRS and those discussions may have relevance to NICEs appraisal process.
The right hon. Member for Rother Valley was absolutely right to highlight NICEs significant international reputation. I was interested to hear that NICE representatives visited Scotland, France and CanadaI am not sure whether it was in that order. He may be awareif he is not, I am sure that he will be interested to hear itthat both main Democrat candidates in the United States are examining NICE with a view to introducing a similar structure if either of them is elected President in November.
We then heard from the hon. Member for Wyre Forest (Dr. Taylor), who made another engaging and informed contribution. He rightly highlighted the key element in the use of experts. We agree with the Government that that is a matter for NICE rather than central Government, but there is a great deal of concern among patient groups, clinicians and the pharmaceutical industry that the appropriate and necessary expert advice is not available when the appraisal committees are under way.
The hon. Gentleman was right to highlight the confusion between the various guidance categories. There is confusion, not only in the public domain, although that is important, but sometimes in the clinical domain, and there is a job for NICE to ensure that everyone concerned with the process understands the different guidance categories. I am, however, not sure about his assertion that NICE should override clinical decisions on the ground and clinical freedom. He was also right to highlight the optimal practice reviews and to tackle inappropriate prescribing, which is a debate in itself.
The hon. Member for Dartford (Dr. Stoate) rightly stated that we must strive to improve the national health service, particularly and most importantly patient care. He was right to highlight the complexity of resource allocation, which I think can be done only through a much more transparent and accountable structure and system that we have now. I was fascinated to hear his detailed analysis of the mechanisms behind QALYs, which I am sure he and all other hon. Members acknowledge are extremely complicated. They work well in some circumstances but, unfortunately, they do not work well in too many instances at present.
As the House knows, my hon. Friend the Member for Basingstoke (Mrs. Miller) is an assiduous constituency Member of Parliament. She rightly highlighted the importance of evaluation, the non-statutory guidelines, and the future of the pharmaceutical industry, which has particular pertinence to employment in her constituency.
My hon. Friends points about slow take-up by primary care trusts in her constituency resonate with my experience in my constituency, not only in comparison with other primary care trusts, but in the disparities and inconsistencies within primary care trusts. The matter is difficult to explain to patients and constituents who clearly do not understand why one patient should have access to a particular drug or technology when another does not. There must be much closer examination of consistency of criteria in primary care trusts. There is little transparency in the decision-making process, and that creates enormous angst, particularly in sensitive areas such as IVF treatment.
Sandra Gidley: I agree wholeheartedly with the hon. Gentleman, but does he agree that one aspect of the inconsistency is that the small committees on the PCT that deal with each case on a case-by-case basis often comprise different people, so there is not the consistency that, after I intervened, he claimed was needed? I would be interested to know whether he has any solutions for providing more transparency and consistency. The subject hits every hon. Members postbag.
Mark Simmonds: I agree with the first part of the hon. Ladys intervention that this is an extremely important matter which should be examined, but I am afraid that today I do not have a simplistic solution to improve the situation. There is tension for all main political parties in wanting to provide consistent provision of healthcare while ensuring that decisions are made locally if they are relevant to the local communities which the primary care trusts and clinicians serve. That tension is difficult to resolve.
The hon. Lady was right to highlight in her speech the QALY threshold and constituency concerns. She made a good point about the new social care body that will be set up. I suspect that the Government are using that as a way of kicking into the very long grass the other complex issues that she eloquently articulated.
Conservative Members support NICE and believe that it plays a vital role in assessing the cost-effectiveness and clinical effectiveness of treatments, as well as producing clinical and public health guidance. Rising patient expectations, an ageing population, and the development of more costly procedures, drugs and technologies will make the context in which the NHS and NICE must operate far more challenging in future. It is absolutely right, as other hon. Members have said, that the body
that analyses the cost-effectiveness of treatment is made up of clinicians, rather than politicians. We agree with the Committee that it was unwise of the previous Secretary of State to become involved in the debate about Herceptin.
The Committee was right to highlight and praise NICEs work nationally and its international reputation. It was also right to shine a light into those areas where there are problems in NICEs existing structures and procedures. I know from discussions with executives and people working at NICE that they are the first to acknowledge that the situation is not perfect.
The Committee made a large number of recommendations. I do not want to go through all of themthere is not the time to do sobut I want to highlight three or four key areas that deserve further discussion, including topic selection, QALYs, disinvestment, clinical trials, societal costs, the membership of the appraisal committee, consultation and implementation.
The Committee was correct to highlight public concern about the speed of assessment, which can take up to two years. That results in enormous uncertainty and a period of variation that is often euphemistically called NICE blight, during which primary care trusts set their own prescribing criteria almost at will, without transparency or consistency. All hon. Members know from their postbags that that leads to anger among patients and their families, and reinforces concern about postcode lottery and the publics view that NICE is a hinderer and not an enabler of access to drugs and technologies. Somehow, we must turn that perception round. Hon. Members rightly highlighted the swifter procedures in Scotland and France, but it is clear that the processes there are less rigorous as there is no scoping phase, and public consultation is limited, which would create issues if we tried to replicate that in England through the NICE procedure. I will come to that in a moment. We welcome single technology appraisals, which are obviously quicker, but we also believe that there is a role for multiple technology appraisals, particularly when there is more than one drug or technology in a particular area of health care.
The Committee recommended that drugs should begin their NICE assessment concurrently with the Medicines and Healthcare products Regulatory Agencys licensing procedure. The Chairman and members of the Committee know that Conservative Members have been saying that for a considerable time, so I was pleased to read that the Committee agrees with the our recommendations. I was also pleased to see that in the cancer reform strategy, the Government, too, now agree with that policy in that all new cancer drugs will begin NICE and MRHA assessments simultaneously.
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