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Leela Barham is a freelance health economist and policy expert. She has published in peer-reviewed journals and presented at national and international conferences. She has provided advice to the Department of Health and Social Care on policy on pricing of branded medicines to inform the negotiation of a successor to the UK’s Pharmaceutical Price Regulation Scheme (PPRS), the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), as well as worked with patient groups, the NHS, pharmaceutical companies and many others internationally on the economics of healthcare and pharmaceuticals. Contact Leela on firstname.lastname@example.org
Leela Barham talks to Sir David Haslam, the outgoing Chair of UK’s National Institute for Health and Care Excellence (NICE), about the highs and lows of his six-year tenure at the organization.
In 2013, Professor Sir David Haslam (he was knighted last year), a general practitioner by background, became Chair of UK’s National Institute for Health and Care Excellence (NICE), following the departure of the organization’s first Chair, Mike Rawlins. With Professor Haslam now coming to the end of his six-year tenure, Leela Barham caught up with him to hear from the top about the highlights, the lowlights, and what’s to come for NICE in the future.
Haslam is well aware that it might sound like a cliché, but when asked about the best parts of the job as Chair of an agency that is never far from the spotlight, he points to the experience of working with some truly great people. He says that he has “never come across such extraordinarily bright, talented and focused people.” They have to be-it’s a tough job to weather the frequent storms that surround NICE’s work. Those storms are not just about taking decisions about access to new drugs as part of NICE’s Technology Appraisal (TA) programmed (NICE has been referred to in the US as a ‘death panel’ in the past), but also include whether their clinical guidelines result in too many patients being treated.
Haslam is quick to point out that there are, of course, a great many talented people working in the NHS and across the agencies that support the service, but the particular challenge that is working at NICE is something he recognizes. It is surely not be for the faint hearted.
Haslam is expansive in his definition of who works at NICE; it’s not just the staffers. He is “struck by the caliber of people who apply to work with us, such as those who chair the Appraisal Committees. Some of them are world experts in their field, yet they still want to work with NICE.” He thinks the attraction is in how NICE “makes a difference.” Of course, that difference is much like beauty; it’s in the eye of the beholder.
Haslam is eager to point to the wide range of work that NICE does. “There’s an awful lot more to NICE than HTA,” he says. He points to specific examples, such as NICE’s work on shared decision making. NICE, along with others, has played a role in revitalizing the clinician-patient relationship. This “quite a shift” and something that Haslam is “really pleased with.”
In many ways, the work of NICE is about wider trends that the pharmaceutical industry is engaging with, under the banner of patent centricity. The industry should look beyond the most obvious work on drugs that NICE does and consider how the organization shapes the wider environment, and will continue to do so in the future.
Haslam has experienced what it’s like to be a patient; in 2018 he was diagnosed with cancer of the tonsil. That was his low point during his time at NICE. The diagnosis and resulting treatment “put me out of action for several months,” he says. That must have been particularly frustrating, given a career that has always seen Haslam juggling a lot of balls, be that as a trainee doctor, jobbing General Practitioner, Chairman of the Royal College of General Practitioners or a National Clinical Advisor at the English quality regulator, the Care Quality Commission (CQC).
For Haslam, the experience of being a cancer patient in the NHS has reinforced his appreciation for the great strides made in treating diseases, enabled in large part by research and development (R&D) in the pharmaceutical industry. “One of the things that struck me, being on the receiving end of care, is the impact of the pharmaceutical industry.” He reflects on his time as a medical student, when his brother was diagnosed with leukemia and died shortly afterwards. “I haven’t died from my cancer, and these days, most people don’t die from cancer of the tonsil,” he says. It’s really not possible for those who have not experienced a disease and its treatment to fully appreciate what it feels on the receiving end, he says. “Despite seeing a quarter of a million of patients over my career, I don’t think I had really understood what chemotherapy and radiotherapy are really like. Patients told me, but I only fully understood when I experienced it,” he says.
The logical inference is that NICE must listen to those patients who have taken new drugs when coming to their view. Patients and their representative organizations can and do influence NICE’s work, but some still ask the question, does NICE really listen? Then, of course, there is the rumbling debate about just how independent patients and their representative organizations are when they receive cash from the pharma industry. For Haslam, that means that there is an issue to declare, but not that they should not be there. “It’s terribly important that industry does work with patients and patient organizations to understand their views. We can’t be critical that industry wants to relate to patients and patient groups. But we do want this to be openly declared.”
Of course, being a patient was not easy; Haslam describes his treatment with radiotherapy and chemotherapy as “brutal and unpleasant.” While he was out of action, he could rely on the Vice Chair, as well as the broader NICE team, to make sure his job was being done. That perhaps bodes well for when Haslam leaves, and will provide some continuity as the new Chair – whoever that may be – gets settled in. Of course, NICE’s Chief Executive also remains the same; Andrew Dillon has held that job since NICE was established back in 1999.
There was no shortage of controversy during Haslam’s tenure as Chair of NICE. The controversies surrounded individual pieces of work on drugs and treatment pathways, as well as cross-cutting themes. An issue that comes up often – and in many guises – is simply that NICE hasn’t got the formula right for looking at the clinical and cost effectiveness of new drugs. In fairness, NICE doesn’t claim to always have it right; instead, as Haslam points out, it is “open to evolution.”
Haslam explains how NICE has to“absolutely stick to the processes and methods manual because everything [it] does is open to legal challenge.” That doesn’t stop NICE revisiting these processes over time, just as it has started to do in looking at the methods for TAs and other types of guidance in 2019. This commitment was agreed as part of the 2019 Voluntary Scheme for Branded Medicines Access and Pricing (VPAS), yet as Haslam acknowledges, it’s also just business as usual - NICE has always routinely looked at its methods and actively sought to learn and improve over time. Of course, for some, change is too slow.
The aim of reviewing methods is to do “whatever it takes that gets us to the right answer,” says Haslam. That applies just as much to clinical guidelines as to TAs. “Why would we not want to get to the right answer?” he asks. He believes that NICE is – and will continue to be open “and our consultation [on the methods for TAs] when we carry it out will be genuine; we do listen.” This makes NICE stand out from some other agencies, Haslam believes. That said, he does acknowledge that “you can’t please all the people all the time.”
The Cancer Drugs Fund (CDF), for example, was established because some felt there was a need for a fund to pay for those drugs NICE said no to, or had not looked at, and thus overcome the limitations in how NICE looked at promising but expensive cancer drugs. Just as with NICE’s methods and processes, the CDF has itself gone through changes over time; no longer does it pay when NICE says no. The changes to the CDF – now more akin to coverage with evidence development, which allows more evidence to be gathered before final decisions on routine funding are made, and crucially, no longer sitting outside of NICE - is something that Haslam cites as “perhaps the biggest change” during his tenure as Chair when it comes to drugs. “I was never particularly happy with David Cameron’s original model; the current iteration has real promise,” says Haslam. “It’s no longer a simple yes or now; now we can have conditional yeses.” While Haslam doesn’t comment on the promise for such a conditional approach to funding outside of cancer, with breakthroughs in other therapy areas showing much promise, albeit with clinical uncertainties and high price tags, perhaps evolution at NICE will see the wider application of the interim funding model in the future.
Not really a controversy, but a recurring issue that NICE has to proactively manage, is conflict of interest. According to Haslam, this is something that takes up a great deal of time at the agency. He says: “The Board probably spent more time on the issue of conflicts of interest over the last few years than almost anything else.” This effort is because of the range of NICE’s work – conflicts can happen in all aspects of care – but also because getting decisions right requires experts. Those experts may well have developed their expertise by working for, and with, those who have vested interests. Haslam points out that “conflict of interest issues applies across all our work, and it is extraordinarily important. We have to strike a balance between expertise, which almost certainly means a link with all manner of stakeholders, and a lack of expertise, which means we don’t want to involve them.” He explains: “The easiest way to address conflict of interest is to have people who know nothing, which is, of course, ridiculous. It’s fine to have those involved receive funding from industry. What is critical is that those interests are openly declared so that we can appropriately manage them.” There isn’t an automatic response to this, he adds; rather, NICE will look at the detail and deal with the conflict as appropriate.
The job advertisement for a new Chair at NICE went out in June. The final date for submitted applications was this week: August 19, 2019. Whoever gets the role, Haslam recognizes that he or she will bring with their own experience and will make the job their own. This is what he himself had to do; he realized he could never fill the shoes of Mike Rawlins. But he has a suggestion for the new appointee: “Understand the ideas, concerns and expectations of whoever you are talking to.” Haslam has relied on this when working with people from patients through to ministers. Also vital is thehuman skill of “listening and not pre-judging,” he says. “You have to recognize that around the world there are some really good people who want to make a difference.”
At home, NICE is just beginning its work on the review of methods, including methods for TAs. Haslam points to the big changes in the science that are partly driving NICE to look again at how it reviews new drugs: personalized medicine, digital health technologies, and cell and gene therapies. He acknowledges that “keeping the methodology up to date is essential.” The review is just at the beginning stages, and Haslam describes how NICE has been working with stakeholders to develop a shortlist for topics that will be included in the review. There will be a formal public consultation in the summer of 2020 on the detail. A key area is dealing with uncertainty. “Uncertainty is a critical issue. We need to look at how we can use the available evidence including real world evidence and patient experience,” says Haslam. He gives away no clues about what the results of the review might be. But that aligns with his belief that NICE really does listen. The organization should not pre-judge what can and can’t be changed until it’s done its homework and engaged with stakeholders.
Abroad, NICE continues to work with those who are interested to find out more. Haslam says that “there certainly remains considerable international interest in our work.” In fact, international travel has been more of a feature of the role than Haslam expected. “I was recently in Beijing, and I was in Kyoto a couple of weeks before that. These are not necessarily official meetings with governments, but meeting industry and local HTA agencies.” It seems likely that NICE will see international interest in its work continue. Exactly what Brexit will mean for NICE isn’t clear, but Haslam points out that the agency has been working hard to make sure that it can continue to produce guidance quickly even if the regulatory regime is still up in the air.
On a personal level, for Haslam, the short-term future will involves going through the final tests to see if he has the all clear for cancer. If his health permits, he’ll continue working. While he won’t reveal what he might do, he explains that “one rule I’ve had as Chair is not to align myself with any companies or conditions, because of any perception of undue influence on NICE’s work that might relate to those companies or conditions.” He adds, “For now, I am keeping what I might do confidential.” But one thing is clear - he won’t be just playing golf!
Leela Barham is an independent health economist and policy expert who has worked with all stakeholders across the health care system, both in the UK and internationally, working on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).