What is quality of life?

The challenge of deciding how we should decide who deserves treatment from an NHS of finite resource

It cannot be an easy or pleasant job to inform terminally ill cancer patients they will be denied access to effective drugs that have the capacity to extend their lives by months or years.

Moreover, in a society with a publicly funded health service, it is particularly difficult to justify the denial of effective treatment to patients who have paid their taxes, over their working lifetimes, in expectation that they will have access to high quality medical treatment if they fall ill.

Just such an unpleasant, difficult and controversial task has just been carried out by Professor Peter Littlejohns, the clinical director of the National Institute for Health and Clinical Excellence (NICE).

Littlejohns has released a preliminary ruling, denying access to the drugs Sutent, Avastin, Nexavar and Torisel to patients with advanced metastatic kidney cancer. These patients will, on average, die months earlier than those with the same condition in other countries in Europe where such drugs are available.

How can NICE justify its refusal to allow these patients a few extra months of life? Its methodology looks at the cost-effectiveness of medical treatments in terms of cost per extra 'quality-adjusted life year' (QALY).

If a drug or other treatment delivers an extra QALY at roughly £20,000 or less, then the treatment is judged to be cost-effective, and hence recommended. If the sums come out less favourably, then NICE decides against making that drug or treatment available on the NHS.

Although the system has some room for other considerations and can be responsive to special cases, this procedure strikes many as frighteningly cold-hearted and mechanistic. In matters of life and death, these sorts of accountants' calculations can seem cruel and out-of-place.

But what could the alternatives be? The alternative of leaving decisions to the judgement of individual hospital trusts or medical teams has little to recommend it. Firstly, it is difficult to justify a policy that depends on subjective individual judgements. Unless there are explicit public guidelines, like those followed by NICE, it is impossible to see how decisions over health-rationing could possibly be justified to those affected.

Secondly, if such decisions are made locally rather than nationally, we are thrown into the familiar problems of the 'post-code lottery'. A patient in Nottingham may find herself denied treatment that is provided to someone in Newcastle. Allowing matters of life and death to depend on the good or bad luck of geographical location seems like the very opposite of finding justifiable policies.

Another alternative might simply be to fund all medically effective treatments. But this aim would be impossible to realise. One could, after all, always produce some small marginal gain in expected QALYs with a limitlessly expandable healthcare budget.

It may be that, even with the massive increases in the NHS budget over the last eleven years of Labour government, we still do not spend enough on health care. In the UK, we spend somewhere between nine to 10 per cent of our GDP, as against other advanced countries (for example, France and
Germany) which spend nearer to 11 per cent. (Whereas before 1997, Britain spent under seven per cent of its GDP on healthcare.) But no matter how large a proportion of GDP we spend, we would still face budgetary constraints.

Hard choices have to be made: funding certain treatments will always mean not funding others.

Perhaps NICE has found the least objectionable way of performing an unenviable task. But there are potential problems with its QALY-based methodology. First of all, there is the very idea of 'quality-adjusting' a year of life. The intuitive idea is that a year of pain-free, high-functioning life is better than a year of painful, highly limited living. This seems plausible enough, but it is notoriously difficult to make judgements of 'quality of life' in any kind of fine-grained way. Some patients may consider another year of life to be of enormous value, no matter what its pains or indignities.

The calculus of QALYs can also lead to some strange decisions. For example, giving an extra 10 years of healthy life to a 15 year old would be weighed identically to giving 10 years of life to a 65 year old. But, looking beyond QALYs, most people would think it right to favour the younger patient over the older. The QALY approach had no room for these ideas of a 'fair innings'.

It can also find no room for favouring those already suffering from other forms of disadvantage over those who are otherwise advantaged.

Indeed, the QALY-approach will favour a treatment that gives X additional years of life to a 30 year-old able-bodied person, rather than X additional years to a 30 year-old disabled person, which seems quite unjust. A more just system might also give more emphasis to the diseases of the poor over the diseases of the wealthy.

We should also bear in mind that the costs of various drug treatments are not entirely fixed. Instead, those costs often depend on the price levels that profit-maximising pharmaceutical companies think they can get away with. Many pharmaceutical companies spend vast sums on the questionable practice of direct marketing to doctors, as well as funding partisan or self-serving forms of research, all of which push up the prices paid by the NHS.

Bob Essner, the CEO of Wyeth (which makes Torisel) took home $24.1 million in pay in 2007, while Jeff Kindler of Pfizer (makers of Sutent) made $12.6 million. The cost per-QALY of these drugs could no doubt be reduced if they didn't have to generate the obscene salaries of corporate fat cats like these.

NICE's QALY-based approach is a useful tool, creating the possibility of publicly justifiable decisions over healthcare rationing. But we should not lose sight of the broader regulatory context when considering how the NHS should apportion its spending on drugs. There is little doubt that a more responsible and better regulated pharmaceutical industry would mean NICE had fewer tough choices to make.

Perhaps the most interesting aspect of a QALY-based approach, though, is what it can tell us about broader issues of government policy and health outcomes. For, it turns out, what really makes a difference to the number of QALYs that individuals can look forward to depends more on factors like diet, exercise and early detection of disease, rather than the availability of expensive pharmaceuticals.

Following NICE's procedures to their full conclusion would suggest a massive move towards a pro-active rather than a reactive NHS, with more resources devoted to screening and public health measures, rather than to the treatment of those who are already nearing the end of their lives.

Moreover, as public health researchers like Sir Michael Marmot, Richard Wilkinson and Ichiro Kawachi have discovered, social inequalities have a massive impact on life-expectancy (and hence on QALYs).

More egalitarian societies, like Sweden, Denmark and Iceland, have higher average life-expectancies, even when controlling for all other factors, than do less just societies like the UK.

Indeed, as inequalities go on rising in the US, average life-expectancy is actually falling there for the very first time.

So, if NICE's approach has much to recommend it, it leads us to the conclusion that a concern with the health of our society leads us beyond thinking only about the NHS, but encompasses much broader policies for securing social justice.