This week: Sir Andrew Dillon, chief executive of the National Institute for Health and Care Excellence
Why he matters: NICE is 20 years old and for its entire life it has had the same chief executive. The regulator’s globally recognised success is in large part down to Sir Andrew’s skill at managing NICE’s often controversial remit.
“We do something that’s recognised to be useful by a significantly wide constituency.”
That – in a nutshell – is the secret to NICE’s success according to its chief executive, adding it helps that no-one else can or would want to do what NICE does.
But Sir Andrew acknowledges that it is good relationships with its stakeholders – the NHS, patient groups, the life sciences sector and, most importantly, government – that has stopped NICE suffering the fate of the scores of agencies that have come and gone in its lifetime.
“Most of our money comes from the Department of Health and Social Care, so it’s not as if we can pretend somehow that we have no accountability other than to the truth”.
The response, he says, has been “to recognise the sensitivity and the challenge of what NICE does”, and while never seeking “permission” from ministers or civil servants for its decisions, making sure its paymasters are always “informed” about what is happening.
“We can explain the nature of what we’re doing and help them prepare for the challenge that might be presented to them”, he explains.
Sir Andrew says that he gets letters “every day” from MPs wanting to know more about decisions that NICE has taken or is taking.
He claims that politicians find it “very powerful” to have an organisation which “subjectively and transparently goes about reaching conclusions [and] which they can trust to call in a way that is consistent with the job that they’ve been asked to do [by government].
“The outcome of [a NICE decision] may not be very comfortable and in individual cases, [politicians] may very much have wanted us to reach some other conclusion, but in explaining the consequences to their constituents, [NICE] is very helpful.”
Sir Andrew describes NICE as being “in the middle” of the constant debate about the funding of the NHS, subject to the often-misaligned ambitions of the NHS of government, the public, and the life sciences sector.
He describes NICE as “constantly having to triangulate a position which is the best fix that reconciles all of that at any point in time. Sometimes [that means] microscopic movements, sometimes big changes that affect the way we go about making decisions.
“As we make those adjustments, an observer might well say ‘there you go. Clearly NICE has been rolled over. The department have not allowed it to do this or they’ve asked it to do that, or the industry has placed pressure on it’. And clearly from that observer’s perspective it might look like that, but it’s not.”
The scrupulously polite Sir Andrew apologies to The Bedpan that he cannot think of a “juicy” incident in which a politician or senior civil servant has directly tried to influence a NICE decision in an inappropriate way – largely because its role is so well understood and appreciated in Whitehall.
When The Bedpan suggests it strains credibility to suggest NICE had never come under any sort of political pressure, its chief executive does admit the possibility of indirect influence.
Patricia Hewitt [health secretary 2005-2007] “is widely regarded as having told NICE to say ‘yes’” to the use of Herceptin for the treatment of metastatic breast cancer, remembers Sir Andrew.
That is “not true”, he claims. But she did tell primary care trusts they could authorise use of the drug if they wanted to while they waited for the NICE guidance.
“We were aware of that and you could regard that as a kind of pressure,” he notes.
The over-riding characteristic of Sir Andrew’s time at the helm has been NICE’s sure-footed handling of sensitive tasks, but surely the institute has made mistakes? Asked what NICE’s “biggest misjudgement” has been, Sir Andrew chooses to discuss its work on safe staffing – without suggesting it was the Institute’s greatest or only misstep.
The second Francis report recommended that NICE make evidence-based recommendations for safe staffing levels. The institute was asked by DHSC and NHS England to take on the work – producing guidance initially for acute wards and separately maternity units. However, before it published the next major piece of guidance – on the staffing for emergency departments – NHS England intervened to ask DHSC to stop the work.
There was considerable speculation that this intervention had been made because NHSE was concerned the A&E recommendations would have required the NHS to significantly increase staffing levels. This was confirmed when HSJ secured a leaked copy of the completed guidance that showed NICE would have recommended minimum ratios of nurses to certain settings within A&E departments.
Safe staffing work transferred to NHS Improvement, whose recommendations, while considering the available evidence, did not follow the methodology used by NICE. Sir Robert Francis told HSJ the guidance by NHSI did not satisfy his recommendations.
Sir Andrew says the NICE safe staffing guidance was “as good as anything else that we’ve done” and was produced using the Institute’s tried and tested method of “finding the right people” to examine the available evidence base.
But he now says that NICE and its commissioners should have “spent more time thinking about the nature of the customer for the guidance and the potential impact of that guidance on the system.”
This “impact”, he notes, “was different in many respects from the impacts that we were [normally] looking at, whether you could acquire and afford [pharmaceutical] products, for example.”
Staffing is a “a massive cost for the health and care system”, he continues, “so small adjustments at the margins about how to staff a hospital, for example, when multiplied across the system has, potentially, a significant impact”.
Given the NHS was struggling at the time – as it is today – with recruitment and retention, Sir Andrew wonders how the service would have reacted to the unmediated publication of guidance which required it to employ more people.
He says the decision to examine safe staffing “would have been well served by a longer conversation” examining how the system and individual organisations would be expected to respond if and when NICE produced guidance.
He also feels more attention should have given to “what arrangements needed to be put in place to ensure the guidance was seem to be a positive contribution to managing a very difficult situation”.
Sir Andrew’s denies the lack of this “longer conversation” means that any of the main players, including NICE, were “negligent” or that they could be accused of making some “fundamental error that it was easily possible for us to avoid.”
The arrival of NHS England
The history of NICE can be very roughly divided into two chapters. The first, running from its birth until 2012, was characterised by NHS funding trending well above the average and NICE being the main influencer on which medicines the NHS had access to.
The second chapter, beginning in 2012, saw funding growth slump towards a historic low and the birth of a ‘national commissioner’ which took the lead on “affordability” of medicines alongside NICE’s “value for money” judgements.
The creation of NHS England did not lead to any changes to the way NICE calculates value for money, says Sir Andrew, but it has affected how they apply that methodology.
“[The existence of NHS England] makes it easier [for NICE] because we now have a proxy voice for the system [which can express] both its requirements of NICE and its views about what NICE is doing. They are a place we can go to and say, ‘what are the priorities of the system, how do we sift and sort the order of what we do, where is the budget challenge, how can we work with you to better manage the introduction of new approaches to practice and new technologies?’”
However, Sir Andrew admits NICE has had to think hard about how to accommodate NHS England’s desire to control the cost of expensive new drugs by holding direct talks with the manufacturer before and during the VFM judgement made by the Institute, and then – potentially – to phase in their implementation over a much longer period than the standard 90 days.
He says NICE has asked itself two questions: “How do we incorporate [NHS England’s wishes] into our processes without our independence, our objectivity being compromised; and how do we make sure that NHS England can speak to a company without that message being perceived as some pressure [being put] on NICE to steer the ultimate guidance in one way or the other?”
Answering these questions has been easier, says Sir Andrew, because NHSE has no “hidden agenda… to take over what NICE does”. Like the MPs under pressure from the constituents “they do not want to compromise the relationship between NICE and companies that comes up with a defensible judgment, whatever that judgment turns out to be”.
The NICE chief executive claims that the “process designed to facilitate NHSE’s involvement” has been successful enough to avoid the national commissioner asking NICE to extend the introduction phase of a new technology.
“It hasn’t needed to do that”, claims Sir Andrew, because they believe “enough has been done by [NICE and the manufacturer to mitigate the drug’s impact], and it is their responsibility to find the resources to enable the drug to be used.”
The future, and the life sciences sector
Sir Andrew says he is in no doubt that many pharmaceutical companies would claim the UK is a very difficult market for them, and that they are offering the lowest possible price for their products. But he nevertheless hopes they would say their “engagement with NICE is constructive and professional.”
He rejects the idea that the UK is a difficult place to introduce innovative medicines.
“I don’t see how that can be so when NICE looks at pretty much all of the innovative medicines that get introduced to the NHS and are able to produce positive guidance on 85 per cent of them.”
He also gives short shrift to the idea that introduction takes too long.
“I think that was a legitimate criticism in the early years, and to some extent, middle years of NICE. But the world’s changed radically since then. Our aim is now to produce final guidance within 90 days of a product getting its marketing authorisation. So, our target is now the tightest in Europe, [in countries] where there is a proactive decision being made. You can’t do it faster if you’re going to take an upfront decision”.
The NICE boss says the Institute has “pretty good intelligence about what’s coming down the tracks” in terms of new clinical technologies and that it is working on ensuring it has robust methods in place to deal with products which are “a cure or a near cure for an illness with lifetime benefits”.
However, he adds, that should – as likely – this become a more regular event “it’s even more important it isn’t just seen as a methodological challenge for NICE. It’s actually a challenge for everybody who’s involved. It’s a challenge for the health system, particularly in circumstances where they might have to make a very significant amount of money available.
“It’s a challenge for companies who say ‘it’s a fabulous product and we’ve had to spend [a lot] money developing it. Okay, so there’s only 300 patients in the UK, but we still going to want…a significant return for this.’
“They’ve got to recognise that if they want a sustainable relationship with their market, they’re going to have to think about how they would react to that if they were responsible for managing the health system’s resources. They’ve got to think themselves into our shoes, just as we have to work hard to make sure we understand the value proposition [of a new product], including the innovation that goes on with it.
“I think the conventional dynamic that connects the life sciences as a supplier with health systems as a market is going to have to shift to recognise that. It isn’t just simply a question of, ‘these are fantastic new products, uh, sorry, there’s a really big price tag associated with them’. [Suppliers will have to work with healthcare systems to] resolve as much of the uncertainty about the real long-term impacts [of a new technology] as possible and help find a sustainable solution”.
There has been talk of NICE being part of the UK’s post-Brexit trading push.
Sir Andrew says: “We’re very happy to play into any kind of post-Brexit pitch to the world, but the challenge is getting people to pay”.
He explains that those countries which need NICE’s help are unlikely to be able to pay up front.
“It would be fantastic if the government was to say, ‘here’s £1m, we want you to go and be the front-facing evidence-based part of the UK is export drive to the world’. But it’s very difficult to do that on a pay as you go basis. We do some of it, but it’s a pretty challenging process to do from a public sector platform.”
The Bedpan concludes by asking Sir Andrew – who has now turned 65 – how long he will continue to helm NICE.
“I’m too busy celebrating my 20th birthday with NICE to think about it,” he replies.
Next week: Labour MP and cancer patient Chris Bryant
Coming up: Trans child activist Susie Green
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