Richard Norris Pic_thumbThe NHS spent £1.68 billion on medicines in Scotland in 2015/16, nearly 14% of its total budget. Is this too much? Well it’s a large figure, but difficult to say whether it is too much, or not enough. Partly it depends on how well we think the drugs work. If they help people recover from illnesses, or can alleviate pain and suffering, then they may be worth it, and indeed, save money if it means people get back to work quicker or other expensive treatments are not needed.

Comparisons with other healthcare systems are difficult, but according to the OECD (Organisation for Economic Co-operation and Development) spending in the UK as a whole on medicines, as a percentage of healthcare spending, is lower than most other developed countries, but all systems are facing the same problem of rising cost pressures as a result of expensive new medicines coming onto the market. In Scotland this means that as costs of medicines continue to increase ‘they will absorb an increasing proportion of health boards budgets , which means in turn that tough decisions will need to be made about reducing spend in other areas of provision.

And despite the existence of standards and measures for testing the effectiveness of new medicines, there continue to be doubts about just how good some of the new drugs are.

A recent report in the British Medical Journal argues that “Most cancer drugs recently entering the European market do so without clear evidence of extending or improving quality of life” and the research suggests that the majority of cancer drugs approved from 2009 to 2013 were “without evidence of a survival or quality of life benefit. Even when drugs did show survival gains over available treatment options, most of these were not clinically meaningful.”

There are, naturally, high public and political expectations of regulators, and there is difficulty in saying ‘no’ when a drug could be of potential benefit. In many ways, regulatory organisations are in a ‘no win’ situation. If they say no to a new, and potentially life saving drug, they will be seen as denying treatment to people who need it. However saying yes may mean that drugs which deliver toxic side effects as well as costing significant money are prescribed to patients who derive no benefit, but whose hopes have been needlessly raised. Quite often in practice, the ‘evidence’ for whether a new drug works can be less than straightforward, and waiting until full definitive evidence is available may also result in needless suffering as well as strong pressure from patient groups and politicians.

Even if expensive drugs are of benefit, it may be that there is an ‘opportunity cost’ and that more benefit could have come from spending that money on something else. Inequity in spending on healthcare has long been a potent issue, as Dr Brian Montgomery recognised in his recent review on access to new medicines where he notes concerns that “medicines were not being treated equitably when compared with other healthcare treatments and technologies.” And recently, a member of the Scottish Parliament Health and Sport Committee called for “a national conversation about some of the very expensive drugs that are coming along that deliver marginal benefits…”

There are many complex ethical issues involved in this. Is it right that one patient can get access to expensive drugs when others who require other interventions have to go without? In trying to make comparisons, is it right to purely look at ‘health benefit’ (even assuming this comparison can be done fairly and accurately) without also understanding other societal values, like the ‘rule of rescue’, which refers to a widespread view that we should prioritise resources on ‘saving’ people at risk. A strict utilitarian ‘outcomes’ approach for example, is not applied to whether we should spend money rescuing people from natural disasters, or people who are lost on mountains, even though we could probably spend this money more effectively on achieving other outcomes. People expect the NHS to come to our aid when we are severely ill, and its ability to do that forms an important part of our societal expectations when paying taxes to support it.

The issue is much wider than medicines, and all healthcare resources are finite and have to be managed and delivered effectively and in a way that is seen to be fair. In practice, many prioritisation decisions will be taken at the ‘micro’ level i.e. where patients/users meet on an individual basis with professionals and service providers. For example GPs act as ‘gatekeepers’ in terms of referring people onward to services, and waiting lists are one way of restricting services in practice.

Most prioritisation decisions are made ‘implicitly’ rather than ‘explicitly’. The requirement for flexible, person-centred care, and the need to take into account emotions, aspirations and preferences means that decisions about the most effective treatments for particular patients/users should be shared decisions between those receiving and providing treatment, rather than being made by formal committees meeting in public.

Explicit decision making is best restricted to setting frameworks, establishing limits to resources, and producing formulas for fairly distributing healthcare, as the academic David Mechanic argues in his paper ‘Muddling through elegantly’. However, this leaves a vast area for deliberation and dispute.

In Scotland there is guidance on prioritisation for the NHS at local level but at both local and national level ‘cost effectiveness’ can often serve as a proxy for prioritisation decisions.

Organisations such as the Scottish Medicines Consortium, the Scottish Health Technologies Group, and SIGN (the Scottish Intercollegiate Guidelines Network) make evidence based decisions on what treatments and approaches should be used by the NHS. However, this doesn’t necessarily mean that these organisations find it easy to make difficult decisions. Attempts around the world in having transparent and explicit prioritisation seem to demonstrate that in fact the more public and transparent the process is, the less easy it becomes to prioritise particular treatments or to say ‘no’. This is because public and political awareness is raised and focused on the areas where someone may be denied treatment, rather than on the more complex ‘trade off’ or opportunity cost issues which have system wide consequences. One study looking at approaches in eight countries found little evidence that having explicit processes had led to changes in practice or savings, and that in fact “the more that rationing decisions are made public and explicit, the less likely that a public insurance system is able to ration services.” This is known as ‘the political paradox of rationing’.

On the one hand it is clearly in everyone’s interest to have a transparent, open and fair system for allocating healthcare resources, and indeed natural justice and democratic principles of accountability seem to demand it. But in practice this can lead to conflict and an avoidance of, rather than engagement with, difficult decisions. Those with the loudest or most influential voices, or the most easily measured ‘need’ may prevail regardless of whether that is fair. There is currently no settled view about how we get the right balance, but with developments in personal medicine, genomics and artificial intelligence likely to bring new challenges, not just in terms of cost but also in how we define healthcare, we have to continue questioning what the best system for making choices looks like. We will need to develop new and innovative ways of involving the public and understanding societal views if the NHS is to continue to maintain public confidence and distribute healthcare resources fairly. In a future blog I will explore what some of these methods may be.

 

What do you think? I would be interested to hear your views. Please email me at Richard.Norris@ed.ac.uk