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This coming Monday – 1 April 2019, or All Fools’ Day – is the sixth anniversary of the implementation of Andrew Lansley’s Health and Social Care Act, 2012. An Act that everyone from the Prime Minister down appears to agree now needs amending.
But it is also the twentieth anniversary of the arrival of the National Institute for Health and Care Excellence (NICE). And that has to be an occasion for a birthday cake and a few celebratory fireworks.
For NICE has clearly been a success, and a big one at that. For a start it is still there – of the many arm’s length bodies that the previous Labour government created, NICE is one of the few still in existence with its core remit and purposes intact, and in health just about the only one.
Set up in part to provide an authoritative source of guidelines on best practice, it has made sense of the wild west of different guidelines from different bodies of decidedly different weight and value that existed previously. While assessing accurately how far they have been adopted is no easy task, there can be little doubt that they have improved the quality of care for patients. And while that is not the part of its work which normally attracts the headlines, it is arguably at least as important as the part of its work that does: its assessment of whether costly new technologies in general, and pharmaceuticals in particular, are cost effective. And thus whether the NHS should be recommended and, in the case of drugs, required to adopt them.1
In the headline-grabbing area of its work, NICE has lived a life of semi-permanent controversy. Whether there is a definitive threshold of cost effectiveness; whether that threshold is set too high or too low; whether it says ‘yes’ too often or not often enough; whether its decision making is swift enough (it is acknowledged it used not to be: it has improved markedly); whether it has done enough to ensure the ‘de-commissioning’ of treatments of little or no value. In the UK it has been accused of ‘barbarism’ and of ‘condemning patients to an early grave’. In the US it has been characterised as a ‘death panel’. And while NICE has undoubtedly improved the take up of new and cost-effective treatments, it remains the case that, for reasons well beyond the control of NICE itself, uptake can still be too slow.
But it has survived. For a whole bunch of reasons. Its processes, while complex, are pretty transparent for those prepared to engage with them. In its early years in particular it used a Citizen’s Council, a method of establishing the public’s view, to inform its values and ethical judgements. It has been well led. And, crucially, the civil service has retained enough collective memory to remind successive health ministers (and there have been a lot of them) why NICE was set up in the first place. Namely that NICE shields them from decisions around cost-effectiveness and about what the NHS should and should not provide that they are ill-equipped to take. The one significant exception to that – the creation of the Cancer Drugs Fund – in the end simply reinforced the need for NICE.
And while any decision to say ‘no’ is terrible for the patients affected, there is, somewhere out there, an acknowledgement by the public that it is in taxpayers’ interests and, in the long run, of patients themselves, that the cost-ineffective does not drive out the cost-effective.
As for the pharmaceutical industry, it has never had a single view of NICE. There have been differences between the US, European and UK companies and differences within them. At times individual companies have gone to war with NICE before returning to the fold. And it is notable that back in 2010, when Andrew Lansley proposed that NICE should continue to assess cost-effectiveness but no longer make a recommendation on adoption – with individual clinicians making the decision on whether to prescribe – it was not just UK doctors who discovered that they rather liked NICE, but the pharmaceutical industry, too. The two views combined to see that proposal withdrawn. As Sir Michael Rawlins, NICE’s chair, at the time put it, ‘the industry wanted it because any negotiation about price involves a trade-off between price and volume, and without a recommendation from NICE the industry would not have a clear idea about volumes.’ Better the devil you know.
Furthermore, in terms of success, NICE is recognised globally as an exemplar. Its materials, both its guidelines and health technology assessments, are downloaded internationally, inspiring and contributing to similar approaches elsewhere.
Its big birthday, however, does not come without challenges. These are at least as large as those it has already faced. Some arguably of its own making. Others not.
The latter include the arrival of gene and cell therapies and the potential for more ‘personalised’ medicine. These involve some of today’s most exciting science. Some offer the prospect of a one-off cure for the previously incurable. But they come, even by the standards of previous new pharmaceuticals, with eye-wateringly high prices – a step change in the amounts involved – and, sometimes, small populations, or relatively small populations, within which to judge cost-effectiveness. This poses a twin challenge. First, not just to NICE but to similar health technology programmes around the world, of how to adapt what might be dubbed the standard (though always evolving) health technology assessment to these new products in order to reach a sensible judgement about cost effectiveness. And second to health systems, whether they are funded publicly or privately. For them the question is how on earth to afford treatments that can run into the many hundreds of thousands of dollars or pounds per patient, or potentially into the millions, even if they are cost effective.
To tackle the first part of that NICE is co-operating with the US-based Institute for Clinical and Economic Review and the Canadian Agency for Drugs and Technologies in Health to work on the best methods for evaluating these new treatments.
The second is clearly going to require much more imaginative approaches to pricing, an issue with which that at least some parts of the pharmaceutical industry are tangling.
The first evidence of that lies with the recently introduced budget impact test in the UK. Under that, since 2017, if any new technology that NICE has recommended is forecast to cost the NHS more than £20 million in any of its first 3 years, and NHS England fails to negotiate a lower price, then NHS England can propose a slower roll-out for NICE to agree.
To some, at least, this is a major change in the role of NICE. Some will see what follows as semantics. But to date NICE has not been a ‘rationing’ body – despite the Daily Mail describing it as ‘the government’s rationing body’ in virtually every piece of its coverage. It has been there to judge cost effectiveness. Government imposed the funding mandate – that the NHS is expected to fund positive recommendations within 90 days – with NICE itself occasionally extending that but on purely practical grounds. For example the need to put new infrastructure in place or train staff.
Decisions on whether treatment was affordable, once NICE had pronounced it to be cost-effective, were initially – and deliberately – reserved for ministers. And quite right too. Deciding whether something that is cost-effective cannot be afforded is essentially a political decision – not a technical commissioning decision, where it is in a different league to the sorts of decision that commissioners have always taken. For example, on whether to fund non-painful varicose veins, or grommets, or to insist that for some procedures patients must stop smoking or lose weight – decisions that have involved clinical (if sometimes disputed) issues as well as financial ones.
During the 2000s, when the NHS budget was growing fast, the affordability of NICE decisions never became a problem. It is fast becoming one – both because of the sheer cost of some of these new treatments, and because spending growth is, and will remain, much lower.
Since the 2012 Act, this affordability question has, de facto, moved across to NHS England – when, in the view of this author at least, it should remain a ministerial one. Deciding the NHS budget is a political decision. Deciding then that something cannot be afforded even though it is cost effective is also – or should be – a political decision: ‘This is cost effective, but we can’t afford it’, or ‘we can’t afford all of it yet’. And asking NICE to agree to a slower roll-out, on the grounds that something cannot be afforded, turns it into something it has not been to date – a rationing body. It undermines the purity of the model, muddling two important questions that should be kept separate, and risking damage to its standing.
This has yet to happen. Since 2017, some 30 new treatments have been affected by the initial budget impact test – costing more than £20 million in any of the first 3 years. In all but one case, NHS England has been able to negotiate a lower price, so NICE’s potential rationing role has not been invoked. In the one case where the £20 million threshold has continued to be exceeded – the result of NICE changing its guidance on how many patients could benefit from cochlear implants – NHS England decided to fund that. So, again, NICE’s new rationing role has not come into play.
On that measure, the budget impact test has to date been a success – leading to companies negotiating lower prices with NHS England, and presumably involving at least some innovative pricing structures, although the commercial in confidence nature of these settlements means we know not what. With the industry, NICE and NHS England all seeking to engage with these issues as early as possible, it is a tentative sign that there may yet be a way through the fresh thicket of challenges that all three (and all health systems) face.
It won’t be easy for anyone. The challenges for NICE over the next few years are at least as big as they have ever been. But on Monday a modest glass of champagne is most definitely in order.