The nice way to let people know what is good for them

Whatever NICE’s track record in determining its guidance, it means nothing unless it is put into practice. But just how effective is it at getting its recommendations put to use in an NHS staffed by tens of thousands of independent and highly-trained professionals working in hundreds of autonomous and semi-autonomous organisations and communities across England and Wales, the countries for which NICE has responsibility?

Andrew Dillon recognises that it takes a long time to make an impact; health professionals have to be persuaded to change their practices by demonstrating through evidence that what is being recommended is the right approach in the majority of cases; managers have to resource the implementation of NICE guidance or put in place systems to enable the guidance to be used.

And, as importantly, they have to communicate with the public, the ultimate beneficiaries of the health-care system, to make sure they know the care they should be receiving — potentially a major driver of change in the system.

Despite the scale of the task, he is unfazed: ‘I think we have had quite a significant influence; we’ve got under the skin of the health-care system — which is essential if we are to have a lasting effect. Most health professionals would at the very least say that they respect NICE for the quality of its decisions, even if they don’t always agree with what we come up with.’

It would be surprising if there was immediate and slavish adherence to NICE recommendations; NHS organisations and communities are not consistent, either in terms of their ability and capacity to change and improve, or in their resource base; however, the key, as demonstrated by a number of surveys on barriers to implementation in the NHS, is clinical and managerial leadership.

Those NHS organisations with strong planning capacity are in a minority, with a majority coasting, and a small tail of organisations unable to implement guidance adequately. Addressing this tail is the priority, according to Andrew.

There are other barriers to implementation. At present the Quality Outcomes Framework (QOF), a UK-wide negotiated element of the GP contract that rewards GPs for their performance against a range of clinical indicators, is not consistent with NICE guidance.

‘Incentivising GPs to improve the quality of care for their patients in a way that may not be consistent with national standards, which NICE guidance determines, is illogical and surely untenable. It makes no sense for patients, professionals or the system. Working to put this right is a key aim for this year’, he says.

An area where NICE has already expanded its role is in public health. It took over the responsibilities of the Health Development Agency, successor to the Health Education Authority responsible for the AIDS adverts of the 1980s, in 2005.

NICE published its guidance on obesity in November last year, its first combined prevention and treatment guidance, and, according to Andrew, ‘very much a steer for the future’. For the first time a comprehensive statement of what can be done, and done effectively, has been published and is a reference point for anyone, whether in the NHS or local government, thinking about what their role is in helping reduce the incidence and level of obesity.

‘We have a real problem with obesity; ten years down the line it won’t just be an interesting story in the media: it’ll be a huge community-wide problem for all of us. Now nobody can say they don’t know what works or what they should do’, he says. It is up to others to take this forward now.

Some comparisons have been made between the operation and effectiveness of NICE and the Scottish Medicines Consortium, which looks at the effectiveness of medicines and treatment for the health system in Scotland.

Could NICE learn a thing or two from North of the Border? Andrew first points out the differences: ‘NICE doesn’t look at all new drugs automatically; it selects topics, and so needs to have a transparent selection process to determine what it will evaluate. Subjects picked might be novel treatments for a condition, or around which there may be significant controversy about the benefits, or a treatment that is very expensive.’

Not only does the selection process take time but, also unlike Scotland, NICE has to get sign-off from ministers post-selection process but before the evaluation starts. It is an improvement on pre-November 2006, when ministers and civil servants decided on the selection process too. The new Single Appraisal Process has changed that, cutting the timeline considerably; however, for drugs and medical devices ministers will consult with companies about whether NICE evaluation is appropriate; this can take up to ten months.

If NICE was asked by ministers to examine every new drug and technology that is licensed it would not need ministerial approval for evaluating new drugs. That would make NICE a national drugs and therapeutic committee, doing what the Scottish Medicines Consortium does.

There are different views on whether this would be a good idea — after all, a lot of new drugs, like antibiotics, are relatively routine so why bother with a NICE evaluation? Whether giving up ministerial sign-off is worthwhile is a question that needs to be considered.

Independence of NICE is a major issue. ‘Nobody has ever presented anywhere, to anybody, as far as I’m aware, any evidence whatsoever to suggest that NICE has been influenced by anybody other than through reasoned argument. The Department of Health, patient groups and pharmaceutical companies are entitled to put a view about how the evidence that NICE looks at should be interpreted. But only one set of people will make the decision, and that is our independent advisory body’, he says.

The recent case of herceptin is seen by many as an example of political interference. It starts with a cancer conference in the US in the spring of 2005 at which the academics working on behalf of the manufacturer, Roche, present data on the early-stage treatment of cancer which is enormously encouraging; the news gets flashed around the world.

Organisations, professional and patient, interested in improving outcomes for women with breast cancer, become very excited about it and want to use this drug, already licensed for late-stage treatment of cancer, for early-stage treatment. Pressure builds in every health-care system, including the UK, and that pressure goes right to the top of the system straight away.

‘There’s no license for the drug to be used in early treatment — NICE operates exclusively on the basis of providing advice on licensed treatments — so I can’t do a thing about it. There has been a lot of confusion about what the Secretary of State said at the time. What she said to the NHS was that NICE will look at herceptin and give advice within weeks of the drug getting its license, which we did, but in the meantime you have to make your own local decisions.

‘NICE could have found herceptin to be neither clinically or cost-effective, had that been the view of the independent advisory committee. But that’s not what they said; they recommended we should use it. Our approval of herceptin following the Secretary of State’s encouragement to the NHS to take decisions about it in advance of NICE guidance, led many to assume that one followed the other; that simply wasn’t the case. Our independence was never compromised.’

Eisai and Pfizer have just taken NICE to judicial review for its guidance on the use of three drugs for the treatment of Alzheimers, following the rejection of its appeal by NICE’s appeals panel. Is this part of a greater trend for NICE decisions to be challenged?

‘The rate of appeals hasn’t changed significantly’, Andrew says. He is satisfied with the working of the appeals process: ‘It is not an independent judicial review of NICE’s approach to making recommendations; it’s the end stage of the internal arrangement to make sure that our guidance is a quality product that’s fit for purpose. What it ensures is that nobody who sits on the appeal panel has had any involvement in the development of the recommendations: no member of staff sits on it, no member of NICE’s independent advisory committee sits on it; it’s made up of non-executive directors of NICE and independent members.

‘It’s incumbent on those who feel that the appeals panel has produced the wrong decisions to show that’s the case. I’m not aware of any evidence at all that suggests that’s happened. It’s certainly the case that appeals are upheld, and NICE’s processes are better as a result. I think it works.’

Andrew believes that NICE has brought out in public, for the first time at national level, the complexity and the consequences of making decisions about what a health-care system should do. The measure of its success shouldn’t be the headlines, but whether or not what it’s doing produces a better health service.

‘It is a far better way of making decisions than we’ve had in the past. And for the first time people who contribute to and pay for the NHS can find out what they can expect the NHS to do for them if they get a particular problem. If you get Type 2 diabetes you can read a NICE publication on what you can expect the NHS to do for you. You can take that guidance to a primary care trust, your GP, a hospital, and say, this is the deal that I understand I can expect to get. That is quite a development for patient empowerment and accountability.’

Across the world health-care systems are having to square the circle between unlimited demand and finite supply. There is no choice but to apply resources as efficiently as possible. The US, which has the most complex health system in the world, is presently having an active debate about establishing an equivalent of NICE for the US health-care system. A better tribute may be hard to find.