NICE stands firm, but the public must learn to respect rationing

At the start of the month the National Institute for Health and Clinical Excellence won what some saw as a crucial victory. Despite a high-profile campaign, the body that decides which treatments should be funded by the NHS won a High Court battle over the prescription of drugs to treat Alzheimer's disease.

The High Court ruled that Aricept, Reminyl, and Exelon should only be prescribed free by the NHS to people in moderate stages of the disease, as recommended by NICE's appraisal committee. People in the early or late stages of the disease should not be given the drugs.

It has been a long battle and the ruling seems to have upheld the integrity of the organisation. But is it likely to dampen the growing debate on what patients should expect for free on the NHS?

In May the British Medical Association took the historic step of admitting for the first time that many health treatments will have to be rationed in future because the NHS cannot cope with spiralling patient demand. In A Rational Way Forward for the NHSin England, it argued that some procedures are already in jeopardy.

These include fertility treatment, plastic surgery and operations for varicose veins and minor childhood ailments. The then BMA chairman James Johnson urged the NHS to be more explicit about what it can reasonably afford to do. The terms of the debate would also need to be clarified, he argued.

'It might, for example, address whether current inequities in care caused by pressures to balance the books are preferable to one alternative, which is to set a limit on the availability of some procedures,' he said. He called on politicians to engage in an 'open, honest debate about rationing'.

But it is the public that has furthest to go in understanding the ability of the NHS to provide a fully comprehensive service, argues NICE chair Sir Michael Rawlins. Speaking at a King's Fund debate in May he said MPs were finally starting to be honest about the limitations of the system.

'Twenty years ago politicians were not honest with people about it. They pretended it was possible for everything to be done. It wasn't then and it isn't now.'

Sir Michael said he hoped this awareness would start to filter through to the media and the public. The NHS does not, he pointed out, have a 'bottomless pit of cash'.

Such a debate would be welcomed, says Imperial College London professor of health policy Nick Bosanquet, but must not just focus on the work of NICE.

'This debate and the extension of rationing really needs to be done on a whole-system basis,' he says.

'People have to start accepting that the NHS has finite resources and is not going to be able to pay for everything.'

This would assess the future role of NICE he says: 'Because of initial pressure from the NHS which claimed that NICE appeared to be approving every drug, the organisation seems to have gone the other way and extended its role into rationing.'

And he feels there is a role for private finance to fund certain services where taxpayers' money and the NHS cannot.

More often than not it is NHS managers caught in the middle of the argument. Some primary care trusts have been bitterly criticised for refusing to pay for expensive new cancer drugs, or for treatment to prevent older people from going blind through age-related macular eye degeneration. Not paying for stomach-stapling operations to help obese patients lose weight has also been controversial.

But many of these issues arise because the treatments have not been considered by NICE, leaving PCTs to make decisions individually - and opening them up to accusations of the dreaded 'postcode lottery'.

But such decisions are not made ad hoc. Most PCTs benefit from local committees of health professionals to decide whether to fund medication for complaints not covered in their basic contract with the Department of Health.

These include treatments such as growth hormones for adults, breast reduction and enlargement and incontinence treatments.

Yet Ealing PCT chief executive Robert Creighton says direction from NICE is far more satisfactory than local decision-making, no matter how much effort has gone into it.

The body has brought equity to the system - in other words, either everybody gets a treatment or nobody does, he says.

'There has to be a nationwide process for guiding clinical decisions, and this needs to be rational and objective and judge if particular drugs are cost effective,' Mr Creighton says.

'The NHS needs to do everything it can to educate the public about the nature of finite resources and the need to balance what is reasonably available within the system against the expectation of perfect treatment for all individuals.'

There is a long way to go to win over the public on the issue of rationing, says GP and Commons health select committee member Dr Howard Stoate. He tells of a woman at his constituency surgery demanding the NHS repaid her after going to Germany to have a hip operation that she would have had to wait three months for on the NHS.

A lot of patients do seem to 'want it all and want it now', he says, but the NHS simply cannot fund it all.

The NHS is a collective agreement to spend a set amount of money as efficiently and fairly as possible. It is not open-ended and it relies on a measure of understanding by citizens - but that is lacking in today's society. 'Now they want an MRI scanner in every street,' Dr Stoate says.

NHS Alliance chair Dr Michael Dixon takes a more positive view. He thinks 'the public is ready to have this discussion', despite politicians being eager to avoid the word rationing when talking about the NHS.

He argues there is a role both for practice-based commissioners and PCTs in helping to engage the public in that debate.

'Patient groups, at practice level for example, could be used to great effect to explore the arguments for rationing,' he says.

NICE was set up to bring transparency and systematic thinking to the process of drug rationing by using economic models to weigh up the cost effectiveness of every new drug. This was its first legal challenge and it was vindicated by the outcome.

But it looks likely that unless there is a full and frank debate about rationing, attacks on the principle of using a sophisticated number-crunching system to come to sensitive and individual decisions will continue.

The truth is that in a cash-limited health service, which delivers so much to so many, one person's drug treatment might mean another going without.

Choice may lie at the heart of government policy. But in the case of increasingly expensive technologies and life-saving drugs, the interplay between funding and patient voice looks set to become ever more complex and painful.

Alzheimer's drug ruling: how the argument unfolded

• 1 March 2005: NICE publishes draft guidance recommending Aricept, Reminyl and Exelon, available to alleviate the symptoms of Alzheimer's disease, should no longer be available to patients on the NHS.

• 22 March 2005: NICE gets more than 8,000 letters and e-mails against the draft guidance in an unprecedented response to its public consultation.

• 19 July 2005: The institute publishes a summary of responses to its public consultation.

• 28 November 2005: More than 120 MPs sign an early day motion calling for the NHS to continue funding the drugs.

• 23 January 2006: NICE proposes more restrictions on prescribing the drugs for early and late stages of dementia.

• May 2006: NICE publishes its final appraisal and recommends the drugs are not prescribed on the NHS.

• July 2006: The Alzheimer's Society claims NICE had not followed processes correctly and the decision was 'perverse'.

• October 2006: NICE rejects appeals and restates original appraisal committee guidance that the drugs should be prescribed only for moderate stages.

• January 2007: Campaigners announce their intention to take NICE to the High Court.

• August 2007: The High Court rules in NICE's favour on five counts but upholds a complaint on one count, that NICE breached duties under the Disability Discrimination and Race Relations acts.

Health and happiness: quality-adjusted life years

There is a finite amount of money available and each treatment has to be judged on price. NICE uses a system known as the quality adjusted life-year (QALY), which gives each treatment a score for the benefit it gives in the quality and length of life, which is then compared with cost. QALY judges a year of perfect health as 1, while death represents 0. To judge quality of life, factors like mobility, pain, depression, and the ability for self-care are taken into account.

So a treatment that results in four years of life with a health state of 0.75 gets three QALYs, where as four years with health state of 0.5 is two QALYs.

The QALY is combined with cost to give cost utility ratios which are then used to judge treatment.

The way NICE makes its judgements

NICE's health technology evaluation centre develops guidance on the use of new and existing medicines, treatments, and procedures in the NHS.

NICE bases its recommendations on a review of clinical and economic evidence. Clinical evidence measures how well the medicine or treatment works. Economic evidence examines how well a medicine or treatment works in relation to how much it costs the NHS and whether it represents value for money. NICE technology appraisals are prepared by an independent appraisal committee which includes health professionals working in the NHS and people who are familiar with the issues affecting patients and carers.