NICE gives evidence on the Health and Social Care Bill

Sir Andrew DillonThe health and social care system in England is being significantly reformed to put patients at the heart of the health and care service, giving them greater control over their health.

The Bill is currently going through the House of Commons in order to finalise the policies, set out in the White Paper Equity and Excellence: Liberating the NHS, that require primary legislation.

Last week, Sir Andrew Dillon, Chief Executive of NICE, gave evidence to the Public Bill Committee, as part of the Committee stage of the Bill's progress through the House of Commons.

First up to question Mr Dillon was Kevin Barron MP, former chairman of the Health Select Committee.

Kevin Barron MP: “NICE will no longer make a judgment on the cost of new drugs and whether the NHS can afford them. Instead, the Government want to move to a value-based pricing system where they take a central role in deciding on price and, GP commissioning aside, if the local NHS can afford it.

“Given your organisation's involvement in new drugs particularly over the past few years, will you retain responsibility to advise Government? What change will it have on the provision of drugs to patients? Do you think it will result in major changes?”

A: Sir Andrew Dillon: “The ambitions set out in the consultation document, and we are still in a consultation phase, are entirely laudable: to fix a price of a drug that reflects accurately the additional benefits it brings over current standard practice; and the plan calls for more transparency and more clarity in what the NHS regards as value for new treatments, so that there is greater predictability in the process for everybody.

“The consultation document indicates that NICE will continue to undertake an evaluation of the clinical and cost-effectiveness of the treatment and will set that out in a context that allows anybody to see the optimal use of the treatment in clinical practice, so we are still going to make our contribution to the process.

“It will still be possible for prescribers and the public to see just where a new treatment really scores in terms of additional benefit compared with what is available at the moment. We need to wait and see what the outcome of the consultation is to see the final arrangements and then to make an assessment of their ultimate impact.”

Q: “For many years now, there has been an argument that the pharmaceutical price regulation scheme has helped to sustain a large part of manufacturing in this country-drugs manufacturing exports total about £9 billion a year.

“Do you think that changing the way the NHS purchases from the pharmaceutical companies will change that? Do you think it will have an effect on our potential to keep a healthy part of the economy running?”

A: “The answer is that it is likely to be on a range of neutral to positive. It can be positive if it achieves the aim of the Government's proposals-achieves our ambition of providing a clearer signal to the pharmaceutical industry about the sorts of products and the sorts of disease areas that we really want the industry to concentrate on.

“We have to recognise that the UK is a small component of any global pharmaceutical company's market, but we are not unimportant. We are significant in lots of different ways, not least because of the status of the NHS and British medicine internationally, and to some extent the work of NICE, so we should not underestimate the impact.

“There is a real potential for having a positive impact on what the industry innovates in. If we are clearer with the industry about what we want, and we carry on paying a fair price for the products that it brings to market, it is a win-win.”

Margot James MP: “Sir Andrew, can I ask how you envisage care pathways, which are going to be the next big thing, being taken up by GP commissioners?

“Do you see it as being almost as ubiquitous as the clinical and cost-effectiveness guidance has been in the past? What are you expecting from Monitor and the commissioning board by way of enforcement?”

A: “The great thing about care pathways is that they display the evidence and recommendations based on the evidence for different forms of practice and lay out the options.

“Although that is actually what happens in most cases-there is rarely a single solution that fits every patient-they do that not just in a way that GPs and other health professionals understand, because it is how they go about their work, but in a way that we all understand, as we experience the evolution of the diseases and conditions that we are going to live with through our lives. It is a great way of doing the job.

“From May, NICE is going to reorient everything that it produces along disease and condition care pathways. Everything that we produce for the NHS-the quality standards, which are a very important component of the new architecture that is being put in place; our work on indicators for the quality and outcomes framework and for the new commissioning outcomes framework; and our contribution to the commissioning guides-will all be laid out along those disease and condition care pathways.

“GPs, both as health professionals and in their commissioning role, can get very easy access to and can reach straightaway for the things that they need to inform the decisions that they take.

“The relationship that we have with the Care Quality Commission is very good. We have worked very closely with it to make sure that there is a clear understanding about the distinction between its registration standards and the more stretching NICE quality standards that are coming out.

“We can work with the CQC in circumstances where there is a particular need to look at the performance of individual institutions or of the NHS generally, in relation to individual aspects of the service that is being provided, by giving it the opportunity to reach for the standard, the evidence or the guidance that it needs to reference its judgments on. There is a good relationship there.

“The role of Monitor is, of course, changing fundamentally. Quality is going to become a much more important component of its work. Again, NICE can provide that evidence-based reference for the judgments that it needs to make, and we have a very good working relationship in place at the moment.”

Owen Smith MP: “Given the complexity of introducing value-based pricing, and the extent to which it is very much understood to be a very difficult issue, are you confident that you will be able to get that resolved and agreed with the industry in time for your divesting your responsibility to provide cost-effectiveness advice to the NHS?”

A: “Yes, I think so. There is quite a long lead-in time. The existing pharmaceutical price regulation scheme does not run out until the end of 2013, and unless everybody thought that there was a great solution that could be put in place straightaway, which would obviously have to include the pharmaceutical industry, there is an opportunity to work this through, test it out and put it in place easily in enough time to convert or amend the current PPRS to take into account value-based pricing from the beginning of 2014.”

Q: “This is a very big change in your role, potentially giving you much more influence over pricing at the outset-at the beginning of the food chain, if you like-but giving you much less influence over prescribing practices. In some respects, NICE was set up to deal with irrationality in GP prescribing practices, but GPs will now be holding the ring and holding the money. Are you worried that you will see less rational prescribing when you have less influence over their activities?

A: “I am not sure that this change will diminish the potential we have to inform the decisions of GPs and, indeed, other prescribers. I am pretty confident that the value-based pricing arrangements will contain the opportunity for NICE to express the optimal use of a treatment in clinical practice.

“Clearly, there will be an associated mechanism in which someone else makes a judgment about whether the offer price is reasonable and whether it stacks up against the additional benefits that a new treatment brings, but the key thing for patients is that there is a national point of reference to go to-we will continue to do this-where you can quickly understand what the new treatment offers and where it fits in with the other options that are available for the treatment and the sequencing of care that patients need.”

Liz Kendall MP: “The long-term problem is how we get the best health and other value out of the NHS budget. You did the guidelines and PCTs often implemented them, but sometimes did not because, they said, they did not have enough money.

“What will be the difference now with GPs being responsible? They still have to decide whether to implement your guidelines, so in that way it is no different-it is just up to GPs now. Is that right?”

A: “That is a really good question. There has never been immediate and slavish adherence to anything that NICE produces. The NHS does not behave in that way in response to national guidance-apart from national pay awards, of course, which are implemented immediately.”

Dr Daniel Poulter MP: “Sir Andrew, you mentioned having an effective dialogue between primary and secondary care providers. How effective do you think that dialogue is currently? Could it be better, and how would the Bill help to improve it, in your view?”

A: “The easy but terribly unhelpful answer to the first question is that it is hugely variable, but of course it is. There are outstanding examples, sometimes across whole PCTs, sometimes in individual clinical areas, where the dialogue is really very good.

“Actually, what I think the GP consortia need to concentrate on is creating a dialogue at individual service level. Institutional mechanisms need to be put in place to allow GPs to do their business with their providers, but I think that a consortium would do well to concentrate on looking at how the clinical networks that have been put in place for different diseases and conditions in some parts of the country, and other networks such as the cancer networks that operate at national level, have worked.

“That is where you really can create a good dialogue, and it becomes much easier to introduce new technologies and new methods of working. It becomes easier to do things that are sometimes very difficult such as changing service configuration.”

Debbie Abrahams MP: “We know that not all treatments and medicines have NICE guidance currently and that some, but not all, areas have effective use of resources groups, for example. How do you think that that will change with the Bill?”

A: “I do not think that the Bill itself will have a direct or immediate impact on the coverage of NICE guidance across the range of diseases and conditions that for which we will be responsible.

“The Bill talks about a catalogue or library of 150 quality standards; that will certainly cover a broad swathe of both health and social care-NICE will extend its responsibilities into social care under the legislation.

“Assuming that NICE continues, and it looks as though it will, we will continue to produce original pieces of work, and over time there will be very little in the way of routine clinical practice-concentrating on the NHS-that will not at some point be covered by some form of NICE guidance. Not everything needs to be, and we need to concentrate on those questions where there is real uncertainty-where either the evidence is equivocal, or there is variation in how the evidence is being interpreted.

“That, I think, is where we have been most helpful, but I agree that there are areas that we have not looked at yet. Learning disabilities would be an example, which given our responsibilities in social care might be a useful area for us to look at. We have not touched on that area, and it would be very useful for us to extend our working to it.”

Dr Poulter: “What role do you envisage the royal colleges playing in that?”

A: “A direct and intimate one, just as they do at the moment, and will continue to do, in the development of NICE guidance. Those pathways, however they are created and whatever they cover, will need to be populated by evidence-based advice of one kind or another.

“I very much hope that NICE is the first port of call for that, but critically, for anything-whether it is generated out of NICE or any other part of the system-to have traction in the system and have its effect it needs to engage and enthuse both the NHS professionals who are delivering care and individual patients and the organisations that speak on their behalf, which are important advocates for designing services locally. The colleges are an enormously important input into anyone's work.”

14 February 2011

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.