Good vintage

NICE, the National Institute for Health and Clinical Excellence, is ten years old this month. It was established as a Special Health Authority (SHA) in 1999 to give advice to the NHS on the clinical and cost effectiveness of drugs and treatments. In April 2005, NICE took over the functions of the former Health Development Agency, and in so doing took on a critical role in public health issues.

NICE formulates three types of clinical guidance: clinical guidelines relating to the management of particular conditions, technology appraisal guidance, including pharmaceuticals, and guidance on the safety and efficacy of interventionist procedures, eg ECT. In addition, NICE develops two forms of public health guidance for the promotion of good health and the prevention of ill health. Public health intervention guidance aims to reduce the risk of illness by promoting healthy lifestyles, and public health programmes aim to improve health and reduce health inequalities. Under the Darzi review of the NHS, the work of NICE is likely to expand over the next four years.

Impartiality
As a SHA NICE is structured like most NHS Boards with a part-time non-executive chair who is supported by a group of part-time non-executive directors. As a SHA, the board is accountable to the Secretary of State for its work programme, and is part of the NHS. Here perhaps lies a problem in the structure and functions of NICE, which proclaims to be completely independent. While the chairman and part-time board members are all vetted by the Appointments Commission, the appointments are ultimately made by the Secretary of State.

Other independent public bodies, like the former Healthcare Commission, have commissioners appointed by the Privy Council and are accountable ultimately to Parliament and not the Secretary of State. In short, their jobs are not under the patronage of a cabinet minister and they can truly claim to be independent of ministers and officials in the department of health. Critics question whether NICE can be truly independent as a SHA in the structure of the NHS.

Some of the more controversial decisions by NICE over the past ten years have led certain parties to believe there was a degree of political influence in these decisions. On other occasions, however, NICE has displayed a welcome independence and come out against the established wisdom of professional interests. A good example of this can be seen in NICE's guidance on the use of atypical anti-psychotic medicines for the treatment of schizophrenia. When considering this issue NICE received very conflicting evidence. The Royal College of Psychiatrists seemed to suggest that use of the older medications was quite acceptable in many cases, however people living with schizophrenia and their carers came out with a very different view, urging NICE to allow wider access to the newer drugs, which seemed to offer more effective outcomes with fewer detrimental side effects. On this occasion NICE came down on the side of the patients and carers and these drugs are now far more commonly used across the country in first onset schizophrenia and in patients with longer term resistance to older style medications.

Strong leadership
The consistency of its leadership has been a clear strength for NICE over its first ten years.

Since its inception, NICE has been led by Andrew Dillon as CEO, a very experienced NHS manager, and chaired by Sir Michael Rawlins, who carries significant clinical credibility. As a NHS body NICE is probably unique in keeping a chair and CEO in place for so long. Most NHS boards have a very high turnover of CEOs and chairs. The Dillon/Rawlins partnership has allowed good corporate memory to be built within the culture of NICE – rare indeed in the NHS today.

Wider role
While the entry of new drugs and products is what catches the headlines, NICE works in a far wider field and has five key work programmes:
•    The Centre for Health Technology Evaluation
•    The Centre for Public Health Excellence
•    The Centre for Clinical Practice
•    The Communications Directorate
•    The Implementation Directorate.

Aside from looking at new products, NICE also examines a whole range of health interventions – many of which are not glamorous or as exciting as new products, but crucial to the care of patients. Two examples are the guidance from NICE on the management of clinical depression in primary care and the guidance on the prevention and care of pressure sores. These are very basic issues of care that directly influence clinical practice and impact on the experience of millions of patients.

One objective of NICE in the early years was to reduce "postcode rationing" and bring about greater equality in access to treatments. This has not always worked; NICE guidance can be fudged or ignored by local PCTs and checking the implementation of NICE guidance within health settings is not entirely in the hands of NICE. The former Healthcare Commission and its successor has a key role in checking compliance with NICE guidance, and SHAs in England and their equivalents in Wales also have a role in keeping an eye on compliance. NICE has no direct influence in Scotland and Northern Ireland. It is important that stakeholders in the health sector, like pharma companies and patient groups can – and do – read NICE guidance in depth, and can – and do – lobby for the guidance to stick. In that respect the communications and implementation arms of NICE are pretty crucial to making sure NICE guidance is respected.

The evaluation process
The way in which NICE goes about checking the value of new drugs and products has been the subject of complaint from some critics, who suggest that it is too protracted and bureaucratic. NICE commissions reviews from centres of excellence across the UK and elsewhere, and runs its findings through a fairly holistic network of stakeholders, including patient and carer networks. This all takes time and is all largely under public scrutiny. Pharma companies and other suppliers are invited to submit detailed evidence into the NICE evaluation process, and this can lead to a substantial amount of documentary evidence that NICE has to sift through and consider. NICE also has a transparent appeals process for any providers that feel a decision is fundamentally flawed.

It is important to remember that no health system in the world has a limitless budget and a means of articulating relative priorities is, therefore, an essential component of healthcare. Before NICE came along this was done in a far-from-transparent manner, usually led by the whim of local clinical teams or health boards. This, in turn, led to a varied level of service provision across the country. NICE may not always get it right, but at least its processes are led by expert opinion, are open and transparent and subject to challenge through a fair appeals system, or ultimately, legal challenge through the courts.

Crucial decisions
It is in the courts that NICE guidance is slowly influencing clinical practice in a fundamental way. Before NICE, courts facing charges of clinical negligence largely arrived at a view based on what a reasonable cross section of medical opinion considered appropriate in each case. This was not satisfactory as doctors would never agree across all specialties. As a result, the outcome of claims by patients was a bit of a lottery and depended on the quality of expert witnesses called before the courts. It is becoming increasingly common for expert witnesses to cite NICE guidance before the courts and the courts are increasingly taking NICE guidance into account when making crucial decisions in complex cases. This trend is likely to continue and all health professionals need to be aware that flouting NICE guidance consistently on a whim, with no evidence base to support actual practice, will be increasingly risky in the future.

Healthcare is not static, and in the modern world change is happening fast. We learn new things daily and the research community is truly global. The task facing NICE is huge. Attempting to ensure evidence-based, cost-effective practice across the whole spectrum of the NHS is daunting and challenging. NICE guidance can never be preserved in aspic, as new evidence can and does emerge constantly. NICE has to keep itself abreast of such changes and keep its guidance under constant review. In such circumstances one is tempted to ask: can NICE ever get it right?

After ten years NICE has a track record that is credible and it has proved its worth to the NHS. In a service working with finite resources, which will become more stretched in the short- and medium-term, someone has to make decisions that ensure the tax payer is getting the best bang for their bucks, with reasonable outcomes in a publicly funded health system. Who is best placed to make such vital decisions? Ministers, who face political pressures and have a short term of office? Public opinion through populist media and the tabloid press? Doctors and other health professions, who can have a myopic view of their own importance on occasions?

On balance, we are probably better served by having a specialist public body looking at these matters as objectively as possible, as transparently as possible and in a manner that allows all relevant stakeholders to have their say in an imperfect world. NICE has its critics, but I suspect that if we did not have NICE somebody would recognise the need to go out and invent it.

The Author
Dr Ray Rowden is an independent health policy analyst and regular contributor to Pharmaceutical Marketing.
To comment on this article, email pm@pmlive.com

 NICE guidance produced since inception

Key opinions on NICE

Sir Michael Rawlins, NICE chairman: "When NICE was established back in 1999, few people held out much hope for our long-term survival. Even the then-Secretary of State for Health, Frank Dobson, when asked whether he thought NICE would be a success, remarked: 'Probably not, but it's worth a bloody good try.' In saying this, he neatly encapsulated the prevailing mood of the time, which was that there was a recognition something had to be done about unacceptable variations in clinical practice, poor uptake of effective treatments, too great a use of inappropriate treatments and continued use of ineffective treatments – and that such an undertaking was probably beyond the capabilities of a single organisation.

That NICE is still here 10 years later, with a greatly expanded remit, says less about Frank Dobson's inability to foresee the future, but rather more about our success in earning and retaining the confidence of patients and the public, health professionals and managers, and the healthcare industry.

The next ten years will see a number of exciting developments within the NHS, including the arrival of NHS Evidence, which will provide even easier access to the guidance NICE and other NHS advisory groups produce each year, and the further expansion of NICE's work programme to embrace devices and diagnostics, as well as quality standards across clinical and public health.
We now hope to build on the achievements of the past, but with recognition of the lessons learnt along the way."

Jessamy Baird, HTA and health outcomes manager, Lilly UK: "Ultimately, NICE and the pharmaceutical industry want the same thing, which is access for patients to the right medicine at the right time. We need, as an industry, to continue working with NICE to ensure that NICE gets the evidence it needs to make the right decisions, but also to ensure that the voices of all stakeholders (manufacturers, clinicians, patients) are genuinely heard within the process. Our key concern is the lack of transparency in the decision criteria used currently and the over-emphasis on cost-effectiveness (the cost per quality adjusted life year or QALY) as part of that decision. There are challenges to be faced in adapting the cost per QALY measure to reflect the differing needs of our patients within society and incorporate the true innovation provided by medicines. Only once this has been resolved, can the way the decision is made nationally by NICE reflect the difficult decisions that are made at a local NHS Trust level about the allocation of scarce NHS resources."

Steve Poulton, commercial operations director, Pfizer UK/Ireland: "While NICE has made significant progress in developing its processes and methods for assessing new medicines over the last ten years, fundamental problems remain. Undue reliance is still being placed on health economic assessments, despite widespread acceptance that the current methods of valuing health gain remain crude. There is still a clear lack of consensus about how to evaluate and model the costs and benefits of many treatments, and concerns remain over the quality of the economic models developed by NICE. Furthermore, the application of a common value-for-money threshold treats all quality adjusted life years (QALYs) as equivalent, which is contrary to NICE's own Citizen Council's recommendation that factors such as severity, rarity, need, and the desirability of innovation should all be reasons to breach the threshold. The introduction of the end-of-life criteria is welcome in that it recognises, for the first time, that the standard NICE assessment approach does not work well in these conditions. However, this issue is not just confined to end of life care settings and further work to develop a more sophisticated decision-making process remains a priority."

Chris Mockler, senior policy consultant at Fleishman-Hillard: "NICE is here to stay. Whatever the feelings that it generated in 1999, when a number of people wanted it to be strangled at birth (and some may still do), the reality is that NICE has established itself as a permanent institution within the NHS and more widely. There is no question of abolishing it and there has not been for some years. Its chairman has played an astute political hand in his dealings with government ministers and officials, and with the opposition parties and parliament.
He can point to NICE's work in appraising large numbers of drugs and devices, as well as issuing guidelines, which has generally achieved a good degree of acceptance.

NICE is reasonably independent and open, and has a high level of international recognition.

Yet genuine concerns remain. Most seriously, the validity of the research-based appraisals carried out by NICE is being increasingly questioned, which goes to the heart of NICE's credibility. The greater reliance on rapid Single Technology Appraisals will not help. The need for other NICE reforms is understood by most interested people, if not by its chairman.  

At the same time NICE is being wrenched into new areas. It will take full responsibility for standards setting in 2010, working with the Quality Care Commission, and for developing and prioritising quality and outcomes framework (QOFs). Reportedly, NICE wants a tripling of its budget to accommodate these and other changes. A very different NICE is emerging. It is anyone's guess how it will look in another decade's time and it will be the challenge of industry to ensure that additional market access barriers are not sewn into the seams of the next incarnation."

Angela McFarlane, director market access, HGS Consultancy: "NICE, with its original political mandate of 'ending the postcode lottery', was almost doomed to fail to deliver the end-game, for several reasons. Firstly, it was a pioneering organisation whose remit had to change from clinical effectiveness to cost effectiveness and, like many pioneers, it got arrows in its back, as everyone underestimated the enormity and complexity of the challenge. Recent changes in respect of STAs and QALY thresholds will improve stakeholder confidence, but there is still a long way to go in respect of transparency – the dementia saga is testament to that. NICE needs to either stop wasting taxpayers' money on issuing guidelines, or change them to national clinical standards, underpinned by statute to implement them fully. The Care Quality Commission, which took over from the Healthcare Commission on April 1, needs to impose financial penalties for non-systematic implementation (there will be winners and losers here - patients, industry and NHS, but either NICE counts or it doesn't), and there are still Primary Care Trusts who use NICE blight strategies explicitly. From a value-for-money perspective, NICE should take heed of the Scottish Medical Council, which seems to arrive at the same results as NICE, on most occasions in a third of the time and, presumably, at a third of the cost."