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There was considerable debate, both today and in the Committees report, on the use of the QALYthe quality adjusted life year. A number of recommendations were made in the Committees report relating to the NICE process, covering issues such as its use of the QALY and the economic perspective to which it works. It is widely acknowledged, as we heard today, that the QALY is the best available tool to assess cost-effectiveness.
However, there is little consensus on the threshold or range that should be adopted. It is precisely for that reason that NICE does not operate a fixed threshold for the approval of a treatment, but uses a range to enable its appraisal committees to consider the cost per QALY among a broad range of evidence. Indeed, the chair of NICE often refers to its use of the quality adjusted life year as a tool not a rule.
NICE and the Government agree that NICEs use of the QALY should be as robust as possible. NICE has commissioned research, through the National Institute for Health Research, to consider public opinion on the QALY, and the Government will consider the need for further research in the light of those findings. The chair of NICE said that he is prepared to hold a workshop with a range of stakeholders to discuss the threshold to allow us to move forward.
The Committee made the attractive recommendation that NICE should consider wider economic costs and benefits, such as those to carers and other public sectors, in its appraisals. I remember discussing the matter when appearing before the Committee. In our response to the Committees report, we agreed to look at this recommendation in more depth. Since then, we have held three focus groups with key stakeholders, including academics and industry and patient groups, to explore the matter further and to assess the range of opinion on the issue. Not surprisingly, the focus groups have generated a most interesting debate, and we will pull together the conclusions before considering how to proceed. Again, I will do my best to keep the Select Committee informed of our progress.
NICE recognises that its methods must continue to evolve to in order meet the needs of the NHS and other stakeholders. That is why it is carrying out a scheduled review of two of its key documents, which provide a framework for its technology appraisals. Those documents cover many of the important issues, and draft documents were recently the subject of full public consultation. NICE is considering all the comments that it has received.
Another key theme in the Committees report, which was rightly touched upon today, was the implementation of NICE guidance. When NICE issues guidance, it is vital that it should be implemented consistently across the country, and the Government have a role in facilitating that implementation. To that end, provision for NICE guidance is made in funding allocations to PCTs, and NICEs technology appraisal guidance is supported by a funding direction, which requires the national health service to make funding available for NICE-recommended drugs within three months of guidance being issued.
Compliance with NICEs technology appraisals is a core standard for the national health service. NHS organisations are required to demonstrate, through the annual health checks, that they are providing funding for NICE-recommended treatments within three months of the guidance being issued. The latest annual health checks, for 2006-07, show that 89 per cent. of NHS organisations are compliant with NICE technology appraisal guidance, which is a 5 per cent. increase on the previous year.
Of course, we still need to make progress. The hon. Member for Romsey (Sandra Gidley) mentioned going to the chief executive of an SHA. When an NHS organisation fails to comply with the technology appraisal
guidance, it is the responsibility of the SHA, in the first instance, to support any of its organisationsI put this politelyto achieve the necessary improvement.
There was an interesting discussion on terminology and the Governments response to the recommendation that we combat public confusion about the status of technology appraisals and other guidance, to which my right hon. Friend the Member for Rother Valley referred, and to consider further whether more helpful terminology could be used to describe the recommendations. The recommendations in NICE guidance are based on the best available evidence, and we expect clinicians to take them fully into account. I heard what the hon. Member for Wyre Forest (Dr. Taylor) said and reflected on the interesting debates that I have with clinicians who take contrary views to one another, let alone NICE or the Government, on how best to take decisions about treating their individual patients. I shall continue to consider that point and to take NICE advice. However, I am still of the view, as was borne out in exchanges in the debate, that a word such as directive might be taken to implyoften things are taken literally rather than interpretedthat it is intended to override clinical decision making. Everything that we do must be balanced by that.
I believe that the guidelines on IVF that said that the NHS should move to offering three cycles were issued by NICE in around 2003. The then Secretary of State for Health, my right hon. Friend the Member for Airdrie and Shotts (John Reid), made it clear that because a lot of areas did not offer one cycle, they must offer that as a minimum and move to offering three cycles over time. In my time as a Health Minister, I have argued for, and commissioned research on, both the availability of IVF treatment in primary care trusts and the criteria, which are decided locally, for who has access to IVF and who does not. I am mightily encouraged by the support from Members on both sides of the House on the issue. I hope that I will have the support of all political parties when I am able to bring forward suggestions on how to accelerate the achievement of the three-cycle offer.
Sandra Gidley: I welcome the Ministers sentiment, but one of the problems in Hampshire, which the hon. Member for Basingstoke (Mrs. Miller) will have noticed, is that as well as the rather strange age criteria, there are a number of social, value-based judgments that differ from area to area. Interestingly, there is a new consultation at SHA level that is supposed to involve people locally. However, one of the local experts in the field was not aware of it. Will the Minister assure us that the consultations will give stakeholders and MPs a real chance to contribute to the debate, because that is not happening?
Dawn Primarolo: There are two steps in the discussion and several processes are involved. The first is to assess what each PCT provides and to seek explanations of how they will move to three cycles. The second issue is the criteria that are used for access to the treatment. There is inconsistency, so we must ascertain exactly what types of criteria are used for accessing treatment. The consultation will also need to considerI am not sure that we are at this point, but I will let the hon. Lady know when we arewhat acceptable criteria are and ask what are the correct clinical criteria to guide those decisions.
That is a complex issue because, for instance, some PCTs take the view that if it is a second partnership and there are children from the husbands first, IVF could not be given. There needs to be a wider discussion of whether such a criterion should be used, which requires exactly the sort of debate on the transparency of such decisions and local choices that the hon. Lady and the hon. Member for Boston and Skegness say that we need to have.
Dawn Primarolo: The hon. Lady is, I believe, referring to the collection of information and to ensuring that PCTs tell us precisely what criteria they have been using and why. SHAs are being used to achieve that. The balance needs to be struck carefully. It is my recollection that all political parties in the House supported devolving decision making to local health communities and primary care trusts so that assessments of the health need in local areas could be made, with resources spent accordingly. We must balance that carefullyit needs finessingwith the full range of treatments and access to care that individuals have because of national requirements.
I assure the hon. Lady that local debates are necessary, and I would implore all Members of Parliament to conduct such debates in their constituencies. I will be interested to find out what her constituents think about the criteria for access to IVF in parallel with the independent research that the Department has commissionedit is being conducted by not the Department, but independent experts. I am sure that we will return to that subject because I sense that all Members share my concern about the future provision of those services.
The Committee was concerned about the implementation of NICEs clinical guidelines. They cover a pathway of care and make a number of recommendations that span all stages of care from the diagnosis of a condition to treatment and rehabilitation. They are more difficult to implement than NICEs technology appraisals and there are often different states of readiness in the NHS. In recognition of that, compliance with clinical guidance is incorporated into the developmental standards, as is compliance with public health guidance. That is where IVF sits in terms of recognising training, facilities, access and planning, and perhaps work force planning as well.
In 2006-07, NHS trusts were asked for the first time to assess themselves against the developmental standard on clinical and cost-effectiveness, which takes account of NICEs clinical guidelines. The results of the pilot assessment of clinical guidelines in health checks are encouraging. The self-assessments showed that 36 per cent. of trusts were making good or excellent progress towards implementing NICE clinical guidance, with a further 55 per cent. making fair progress. Of course, there is more to do and improvement must continue. We recognise that we have a role in supporting NHS organisations to plan for the guidance. The need to plan for NICE guidance is highlighted in the world-class commissioning competencies, which were developed by the Department with the NHS. The Department, in
close partnership with the NHS, is taking forward work to design a supportive and developmental framework to underpin the competencies.
NICE recognises its role in supporting the NHS to implement its guidance. In 2004, it established the implementation directorate. The directorate has improved the support available for the implementation of NICE guidance in a number of ways, such as by employing implementation consultants who work with NHS organisations to advise on and share best practice on implementing guidance. I am pleased to see that their work is welcomed in the Committees report. Implementation consultants have also been welcomed widely by NHS organisations.
In considering the important work of NICE and the Select Committee report, I take a great deal of encouragement from the clear view that NICE is an important institution that will continue to develop and meet the needs of the NHS, and that other stakeholders will be involved. I thank the Committee again for a helpful and stimulating report. I take absolutely the point made by the Chairman in his opening remarks that, having invested a great deal of time and thought in the inquiry, the Committee expects to be kept informed of developments on outstanding matters. I look forward to future discussions with the Committee on those matters.
Mr. Barron: I shall be brief. I congratulate the Minister on speaking for 35 minutes and not mentioning the R-word. I thought it magnificent that rationing did not come into her speech for one second.
The hon. Member for Basingstoke (Mrs. Miller) is quite right: NICEs original decision was three cycles of IVF. At the time, I was the chair of the all-party group on infertility, and I raised the matter on the day that it was announcedI think that it was in October 2004 or 2003at Prime Ministers Question Time. It was suggested that it would not be long before a policy of three cycles was in place, but two years later, in one part of the United Kingdom at least, not even a policy of one cycle was in place. Progress is now being made, and I thank the Minister for that. That said, the reason why the SHAs are considering the matter is that it has always been done by a specialised commissioner and not normally by individual PCTs. In my experience, where individual PCTs have had control, little has been done. My area, south Yorkshire, used specialised commissioning by NORCOM with north Derbyshire and north Nottinghamshire for that type of commission. That is probably why it is being done at that level, but I am pleased that it is being done.
I have three points to make. One relates to implementation, which the hon. Member for Wyre Forest (Dr. Taylor) mentioned. I did not like his saying that once NICE has come to a decision, it should limit clinical freedom. I think that the buzz words are that it should inform clinical decisions. I notice that my hon. Friend the Member for Dartford (Dr. Stoate) did not intervene and get involved, and that he missed it out in his speech a few minutes later. NICE should influence clinical decision making. That is what it is there for: to
improve best practice in the NHS, something that has been going on for 59 and a half years. NICE has a great hand in doing that.
On QALYs, I am happy that my right hon. Friend the Minister is holding workshops and discussions. I hope that she will keep not only the Health Committee but Parliament informed about what happens. As my hon. Friend the Member for Dartford said, clinicians say openly that QALYs are a mechanism to base decisions on made-up stuff. We need to combat the idea that it is made up and that all that needs to be done is to re-jig the formula here and there. It makes no sense to clinicians or to patients. It is important that it should be brought out into the open. The more that is done and the more we understand exactly how the decisions are made, the more we can criticise whatever lack of base those decisions have, but at least it will be with some knowledge and not the idea that it is made up.
My other point concerns the cost of the QALY. The hon. Member for Romsey (Sandra Gidley) said that the threshold is still what it was four years ago: about £30,000. NICE does not admit that it is £30,000, but we know that it is between £20,000 and £30,000. Nobody admits it, but that is the case. That figure has not changed in relation to inflation in the past four years, nor has it changed in relation to the NHS budget, which has increased dramatically in that time. That is the issue: has it had such an influence, given that this Government have made such large increases to the national health service budget? We need to consider that, and I hope that my right hon. Friend will. It should be recognised.
My last point concerns the issue of a faster process for NICE. The hon. Member for Boston and Skegness (Mark Simmonds) said that a faster process could lead to a yes, but later a no. That is absolutely true. In the present situation, after something is licensed, a clinician can prescribe it whether NICE has assessed it or not, and the decision can turn out to be a no at some stage.
The hon. Member for Basingstoke said that NICE could slow down or stop the use of newer drugs as well. Potentially, it could. Our visit to the Scottish Medicines Consortium was interesting. We saw a presentation that I wish I had kept. Two things came up. One was a graph showing the rate of prescribing of licensed drugs that had not yet been assessed by the SMC. The SMC uses a much faster system than ours. Before it takes a decision, the prescribing of drugs increases. If the SMC says no, it tails off very slowly. That is very much like what happens in England, as I understand it. Drugs can be prescribed after they are licensed. If the decision is a no, the rate tails off, because clinicians will still say that that is their drug of choice for the individual patient. I had a similar debate recently about wet age-related macular degeneration, as the decision on it will be made next month. That is the type of debate that we are having in the health service at the moment. It is true that it is an issue.
We also looked at the SMCs output. It is true to say that there could be a yes in England and a no in Scotland, and vice versa, but the output of the two organisations in terms of the decisions that they make is very similar. However, NICE takes a great deal of time to come to its decisions. I remember seeing another graph at the SMC. I will have to choose my words carefully. The graph showed that 85 per cent. of the
worth of a drug is known quicklyI think within four or five weeks. It then takes another couple of months for that figure to rise by between 5 and 10 per cent. of that, so within its period of consideration, the SMC can see as much as 90 per cent. of the worth of a drug. I am not a clinician or a chemist, so I do not understand the matter completely, but it was shown to be an issue. It is very important to keep those things in mind. I have reread what the Government said, which was that because of the current renegotiations on the PPRS, they cannot say in any detail exactly how they will respond. Let us wait and see and hope that they will give it some consideration.
Some pharmaceutical companies are not against the ideacertainly not in principle. I have before me a brief from the pharmaceutical company, Lilly, dealing with the recommendation for a brief evaluation of all medicines. It is unhappy with what we said about having a lower QALY threshold, although more than anything else we had in mind the protection of the public purse. Some new drugs are expensive and could consume large amounts of a PCTs budgeteven increased budgets. When the decision was made on the use of Herceptin at early stages, my PCT said that it could cost it £1 million, which is a lot for any organisation to lose every year. We must recognise that.
I understand why the industry takes the view that it does, and we realise that QALYs are complex. Lilly went on to say that NICE would need to demonstrate flexibility along the same lines as the SMC in the timing of the initial assessmentthat is trueand that there is no right of appeal, as there is with the SMC, where
there is a right to re-submit. We actually met some peopleI do not know whether they sat on the board of the trade organisation, the Association of the British Pharmaceutical Industry, or were from individual pharmaceutical companieswho actually sit in with the SMC. If they think that the evidence in front of them could be betterI am saying this, not themthey would ask for it, as opposed to simply saying, This does not go ahead.
No matter what the pharmaceutical companies or we think about it, the SMC model is worth considering. I was told anecdotally that drugs can be obtained through the SMC quickly, but that it takes a long time to get to prescription, so any delays in the system would need to be looked at as well. If a long time elapses before people start prescribing a drug, that is a delay in itself. However, we need to do the comparison. We are constantly being told in our mail bags and the media that people get new drugs quicker in Scotland.
I thank everyone involved in our report and my right hon. Friend the Minister for responding to the debate. She said that she would keep us informed about the workshop on QALYs and respond further when the renegotiations on the PPRS are out of the way. I thank all Members who have taken part in this debate. Reference has been made to reports in years gone by; this report too will be around for many years. This is not the end for many of the points in the report, and for some of them, it might be just the beginning.