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The Committee also recommended that NICE develop a shorter, less in-depth evaluation of medicines at an early stage. That would obviously have benefits, but I suspect that there are also drawbacks, which must be highlighted. It is widely accepted that a faster process will just result in a faster yes decision for drugs. That seems unlikely. The NICE appraisal that I observed ended in refusal because there was no clinical evidence to support approval. If NICE simply goes through the process faster without other things being put in place, there are likely to be more judicial reviews of decisions. There will also be a potential public backlash if the initial assessment of a drug or technology says yes, but a later more rigorous one changes the guidance and
deems a drug not to be cost-effective. That would lead to the drug being withdrawn from patients already using it, so there would be serious problems in relation to that.
We welcome the pilot of the national public health commissioning network, which has the potential to offer quicker assessments of newly licensed drugs while also taking account of the wider benefits to the community. I certainly urge primary care trusts to engage with that pilot. I look forward to hearing whether that is effective. The Committee criticised NICE for its topic selection, which tends to focus on a small number of new and often expensive products. However, the majority of medicines in routine use in the NHS have never been assessed by NICE. I certainly would not suggest that all drugs and technologies should be assessed by NICE, as that would be a bureaucratic nightmare. However, there must be a system whereby drugs and technologies historically prevalent in the NHS that have been overtaken by other drugs and technologies can be looked at through the eyes of the QALY threshold. I have had numerous conversations with the executive and others at NICE and I understand that it would be difficult to do that without massive bureaucracy and a significant increase in the burden on NICE. However, that still needs to be borne in mind.
I would like to say a few words about the QALY. I do not want to repeat what other hon. Members have said, but criticism of the QALY is not new. Most people recognise that the system has flaws. For example, QALY does not take into account that a change in quality of life fromif I may use fractions0.2 to 0.4 may be more valuable for a patient than a change from 0.8 to 1. Those things are difficult to assess consistently over a range of clinical requirements. A comparable system of measurement is needed. The Committee was concerned that the QALY threshold had never been debated or approved by Parliament. There is no reason why it should not be debated in Parliamentindeed, we have had such a debate todaybut Parliament is not the right place to set the QALY threshold. That should be done by an independent NHS board in consultation with clinicians, Parliament and NICE itself. The QALY threshold needs to be continuously reviewed.
On socio-economic costs and benefits, when NICE was first established, the Department made it clear that it should not take into account economic benefits, the treatment of carers, savings related to benefits, tax allowances, or productivity, as the right hon. Member for Rother Valley rightly said. However, we must make sure that we do not create perverse incentives to focus on treatments that would be beneficial to adults of working age as that would be to the detriment of drugs to treat diseases more commonly found in older people. Of course, we recognise that any change would have to be made through Parliament via a statutory instrument, but that issue still needs to be looked at. In our policy papers, we have said that we should allow NICE to take account of wider societal costs where it is appropriate for it to do so.
I made a point about the pharmaceutical industry and experts, which was mentioned by the hon. Member for Wyre Forest. There are issues that need to be considered in relation to that. I do not agree with the hon. Member for Romsey (Sandra Gidley), who seemed to suggest that the appraisal committees were primarily full of
people who only had financial considerations in mind. That certainly was not my experience when I went to watch the process. Detailed presentations were made and there were debates about the clinical effectiveness of drugs. It is inevitable that if there is a financial threshold, which the QALY ultimately is, there must be financial input into the decisions.
Sandra Gidley: I apologise to the hon. Gentleman for giving the impression that the appraisal committee was dominated by financial people. In response to the remarks made by the hon. Member for Basingstoke (Mrs. Miller), who said that decisions should be made by clinicians, I felt it was only right to put on record that the decision is made by a much wider range of people than some people suspect.
Mark Simmonds: I am grateful to the hon. Lady for clarifying that. The final point I shall make is about the implementation, to which other hon. Members have referred. It is widely acknowledged that primary care trusts often struggle to finance NICE appraisals and guidance. It has been estimated that the cost of funding NICE technology appraisals is up to £1.2 billion a year. In our capacity as Members of Parliament, we regularly hear reports of patchy implementation of NICE appraisals, and about the disparity of speed in the uptake of NICE appraisals. The best example is the one that my hon. Friend the Member for Basingstoke gave about IVF treatments. There is a risk that treatments that NICE has not examined or other areas of health care could be crowded out as primary care trusts are forced to prioritise NICE-evaluated appraisals. Patients with conditions not yet covered by NICE may therefore receive cheaper and less up to date therapies then patients who receive treatments that have been the subject of NICE appraisals.
In addition to the comments that I have made supporting some of the Committees recommendations, there are three or four other areas that we in the Conservative party think that NICE needs to consider to improve its current service provision. We want to use the NHS autonomy and accountability Bill to enshrine NICEs duties and responsibilities on a statutory basis, rather than as a special health authority, as is currently the case. Such a change would provide NICE with a transparent structure for its duties and responsibilities. We also want to give NICE the power to develop evidence-based commissioning guidelines, which would encourage best practice and the achievement of outcome objectives. That would be particularly beneficial in developing a gold standard in areas such as elderly care and long-term conditions.
Other matters to which hon. Members have alluded also need to be considered. The hon. Member for Norwich, North (Dr. Gibson) quite correctly mentioned orphan drugs, which need to be considered in more detail. There is also the matter of post-approval appraisal effectiveness and analysis, and of ensuring that once a drug has been improved, it meets the quality threshold, as was originally envisaged. Again, with the exception of some pharmaceutical companies who analyse the impact and effect of their own drugs, there is little done in that area at the moment.
There is also the problem of NICE blightthe inconsistency of primary care trust decisions and take-up.
There needs to be greater transparency and greater consistency in decision-making criteria issued by primary care trusts and a larger role for NICE in the evaluation of public health services around the country. Such services are not fulfilling their role or functioning as well as they should. Finally, the public perception of NICE is that it hinders rather than enables access to treatments, and all hon. Members need to work together alongside NICE and everyone in the national health service to turn around that perception.
From 1998 to 1999, NICE has done a good job and it is here to stay. However, we must ensure that it is as effective as possible. The Committee report is a significant contribution to that debate and aims to improve the effectiveness of NICE for the benefit of patients.
The Minister of State, Department of Health (Dawn Primarolo): This has been an interesting and thoughtful debate, and I congratulate my right hon. Friend the Member for Rother Valley (Mr. Barron) on opening it. I want to make it clear that I welcome the Committees broad support for NICE and the important work that it undertakes, and I certainly want to add to the compliments about the excellent work that NICE does.
I want to take us back to the time before NICE, when there was a lack of transparency and accountability and a variable local health service. For most of the time, patients were lucky if they could find anything out in the first place. NICE is about providing guidance to the national health service and clinicians on the clinical and cost-effectiveness of new treatments. It helps to minimise inequity in access to health care by addressing variations in practice, and it is a source of robust clinical guidance. As NICE develops its critical mass of expertise and is more widely known about and appreciated in the health service and beyond, many of the points that have been made can be addressedI am thinking in particular about the role of PCTs.
I am sure that the hon. Member for Boston and Skegness (Mark Simmonds) would not want people to run away with the thought that, before NICE, everything was fine in the health service. The important points that he has identified as needing to be grappled with applied then, but they were not transparent and many people did not know about them.
Of course, a number of the Select Committees recommendations were discussed very fully today, and I welcome this opportunity to provide an update on progress, but before I touch on those points, it is important to recognise the caveat that the Government set out in the response to the Committees report, which remains pertinent to certain of the Committees recommendations. I am referring to the current renegotiations with regard to an agreement on the PPRS. A number of the recommendations are relevant to those ongoing negotiations. I am sure that all hon. Members taking part in the debate will understand, therefore, that it would not be appropriate for me to comment on those issues at this point. However, I will give a reminder of the background to the negotiations. In 2006, the OFT produced a report specifically with regard to the PPRS. It made a number of recommendations, to which the Government partially responded. That relates to the process of renegotiation of the PPRS.
As the agreement involves not only the Government, through the Department of Health, but the Association of the British Pharmaceutical Industry, both parties want to clarifyI shall read my words preciselythat although negotiations on a potential new PPRS agreement have begun, neither party is commencing on any speculation on the content of those negotiations. With regard to the six months notice that has been given as part of the negotiations, part of the agreement that has to be renegotiated is the provision of six months notice. The industry is fully aware of that. My right hon. Friend the Member for Rother Valley touched on it and said that it may be a negotiating ploy. It is a requirement of the agreement as we progress that that notice is given.
Several hon. Members discussed risk-sharing schemes and the importance of obtaining maximum value for money in the NHS. The Government will continue to consider specific schemes proposed. We note the recommendations on that in the OFT report and we will respond fully at the appropriate time after concluding negotiations on the PPRS.
Dawn Primarolo: If the hon. Lady will let me reassure her on one further point, I will happily give way. The basis for the negotiations agreed by both the industry and the Government is that the new agreement must deliver value for money, encourage and reward innovation, assist the uptake of new medicines and provide stability, sustainability and predictability for both the NHS and the industry.
Mrs. Miller: I completely endorse the Ministers remarks about value for money. Does she share my concern that the actions taken may not have been interpreted in the way in which she believes that they should have been in the industry in terms of breaking the important agreements on the PPRS? Now, almost three quarters of the pharmaceutical industry feels that there is a level of uncertainty in the pharmaceutical market that is not helping their business. That industry contributes £7 billion a year net to our economy, and it employs 70,000 people, so it is important that we have a good relationship with it.
Dawn Primarolo: I agree that a constructive, productive working relationship with the pharmaceutical industry is vital. I will be happy to send the hon. Lady a copy of the speech that I made at the annual dinner last week, which detailed at some length the co-operation that is already going on and which continues across a much broader field. That co-operation concerns innovation, science and research and developmentthe present Government introduced the R and D tax credit to assist developments in the pharmaceutical industry. I am somewhat hampered in relation to the propositions that the hon. Lady is making from one side of the argument when I have agreed, as part of the negotiations, not to comment while the negotiations are going on. I ask her to reflect on this question: is her party saying that it rejects out of hand the OFT report on the operation of the PPRS? If it does reject that, which is not what it said at the time, it is difficult to see how it could take forward the propositions advanced by the hon. Member for Boston and Skegness.
Sandra Gidley: I have two quick questions. First, with the PPRS, am I correct in thinking that either side can ask for a break after six months? The contract is not weighted on the side of the Government. If the industry was unhappy, it could have made exactly the same move. Secondly, will the Minister clarify when the Sheffield report will be published?
Dawn Primarolo: On the first point, the agreement was between the Government and the industry. The points with regard to renegotiating or issues relating to the agreement are equally accessible by both partners in the agreement. On the second point, I do not have an answer at this stageI did not have it when the hon. Lady first raised the point, but I will ensure that I get the response to her. I realise that this issue is not part of the debate, but with your agreement, Mr. Gale, I will give way to take the last few questions on the PPRS.
Mark Simmonds: I am grateful to the Minister for giving way. I just want to clarify a point that she has raised. Of course we are not against the potential recommendations in the OFT report, and, as I said in my speech, of course we want to move to a value-based pricing structure. However, she will be aware that the concern of the pharmaceutical industry is not that the negotiation or a move to value-based pricing is taking place, but the way in which the Government are doing that and the fact that they have seemingly broken a five-year contract right in the middle.
Dawn Primarolo: I do not agree with the one-sided view that the hon. Gentleman is giving with regard to the negotiations, but I am not in a position at this stage fully to engage him in discussion about the breadth of the negotiations and the possible outcomes. If I can do that at a later stage, I will be more than happy to do so. The matter that we are discussing is an important part of establishing an agreement with the industry that delivers innovation and investment, rewards developments, assists and speeds up the uptake of new medicines and provides stability. Perhaps I should end my remarks at that point.
Mr. Roger Gale (in the Chair): Order. I have allowed the debate to continue because the future of the PPRS is clearly an important subject that Members want to consider. Strictly speaking, however, it is not included in the Select Committee report that we are debating. If she wishes, the Minister may return to the subject in another debate.
Dawn Primarolo: Thank you, Mr. Gale. The Select Committee has raised these issues with me, and some of its recommendations are pertinent to the outcomes of the negotiations. Although I strayed a little, I thought it only right to be as direct as possible with members of the Committee, because they put great store by the matter.
The Committees main recommendation is that NICE should adopt a shorter and faster provisional appraisal process to enable it to publish guidance on all new treatments at the time of launch, proceeding to a more detailed appraisal once more evidence is available. As hon. Members have said, NICE has established an international reputation for the thoroughness of its appraisal process and for the consultative approach that it takes in the development of guidance, which includes an opportunity for anyone registered as a stakeholder to appeal against the appraisal committees decisions.
A slight difference of view was reflected in some contributions to todays debate on the difficulty of achieving that recommendation. I have told the Committee that I want to reflect further on those specific recommendations, following the renegotiation of the PPRS. However, it is important to highlight the fact that the provisional appraisal process recommended by the Committee would reduce NICEs consultation and remove stakeholder rights of appeal. We must carefully consider whether that would be an acceptable sacrifice. Although I accept what my right hon. Friend the Member for Rother Valley said about the thoroughness of the Committees report and about the opportunities to return to the matter, I need to ensure that we can respond on outstanding matters more clearly once the negotiations allow it. I hope that my right hon. Friend, as Chairman of the Committee, will be prepared to assist us in finding ways to do that.
The Government have already taken a number of steps to ensure the timely availability of NICE guidance, as we heard during the debate. In 2005, the Department of Health and NICE introduced the single technology appraisal process to appraise a single drug for a single indication against the standard treatment. That allows NICE to appraise drugs to a faster timetable without reducing the quality of the appraisal. It is important that we continue to reflect on how effective that is.
We also introduced new topic selection arrangements in 2006, which give NICE a greater role in the early stages of topic selection. They are intended to ensure that important new drugs and other technologies are more consistently identified at an early stage. Every Member who has spoken today pressed me on the importance of achieving that.
Even more recently, as we heard from my right hon. Friend the Member for Rother Valley, the cancer reform strategy, published in December 2007, proposed the default position that all new cancer drugs should be referred to NICE for appraisal, if there is sufficient evidence and a large enough patient population. Although the principal aim of that measure is to improve equity of access to cancer treatments, I have recently agreed a change to the topic selection process for cancer topics, which should have the additional benefit of speeding up the referral process.
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