Recently appointed as general manager & vice president of Gilead’s UK and Ireland operations, Hilary Hutton-Squire highlights the uniqueness of the UK’s healthcare system, its expertise in life sciences and global leadership in clinical trials. To her, the UK has to maintain its core differentiators, such as a health technology assessment system that truly appraises value when deciding upon reimbursement and investment.
Hilary, you have very recently been appointed as general manager of Gilead in the UK. What have been the priorities that were laid out for your tenure?
“It is Gilead’s mission to develop innovative treatments in areas of high unmet need. Nobody comes to work in a pharma company wanting to develop a ‘me too’ medicine – everyone wants to find a cure for cancer.”
My responsibilities include the UK and Ireland operations of Gilead, and I have joined at an exciting time. We are a company that started life with some incredibly important innovations in viral diseases (HIV and hepatitis) making a big impact for patients and healthcare professionals in those areas but we are relatively unknown elsewhere. We’re now moving into new therapy areas including cell therapy – one of the most cutting edge areas of oncology – as well as inflammation and non-alcoholic steatohepatitis (NASH). While we are diversifying in our therapy areas, our mission remains the same. It’s about bringing innovation in areas of high unmet patient need and ensuring access for patients in partnership with communities. We have launched 4 new products in HIV and a complete portfolio of cures in Hepatitis C over the last 4 years. We’re busy ensuring access in our current areas of focus, and intensively preparing for the areas we’ll be entering into in order to deliver fast for patients.
On top of this, we have a very dynamic environment in the UK. The NHS is constantly evolving and Brexit will have a big impact on the way we practically go about our business. So we need to stay one step ahead of this wave of change, to make sure that our treatments continue to get to the patients who need them, when they need them.
How is it an advantage for the UK affiliate to have the Europe, Middle East and Australia (EMEA) headquarters of Gilead so close?
Gilead has 3 sites in the UK. Our EMEA head offices are in West London. Our International Regulatory Operations are led out of Cambridge, and our UK & Ireland commercial office is in central London. It’s an advantage for us to have the regional office so close by as it helps create a richer range of career development opportunities for people. The UK and Ireland operation provides great experience for people, having a sophisticated range of market access scenarios to deal with (we have five separate healthcare systems to consider). It’s great for us to have people in our regional office who have worked in, or are able to network substantially with our stakeholders in the UK. Gilead is a company that focusses strongly on external stakeholder interaction – so our European leadership often support us with these interactions with key clinicians, policy makers and payers in the UK.
In this context, what is the significance of the UK operations for Gilead globally?
The UK is important for Gilead globally on a number of levels. Firstly, it represents a significant population and economy so it’s an important market for Gilead, and this is not likely to change in the near term. Furthermore, the UK is very much understood to be the leader for value assessment of medicines. Therefore, when we go through a NICE appraisal process, we know that this will have ramifications well beyond the UK as other countries will certainly look at the way that NICE has assessed the medicine.
Moreover, the UK is a leading scientific research hub, which means that our physicians and academics are often seen as being leaders beyond our national borders. I think it is a real advantage to work so closely with so many academic experts, and to be able to take them and others on the Gilead journey. Indeed, Gilead has always been committed to partnering with scientific communities, which also allows us to develop medicines which bring real value to their clinical practice.
Of course things are changing for the UK and it’s important that Brexit does not make it any harder to run trials or gain regulatory approvals for our medicines. It’s also important that the government and NHS continue to recognise and reward innovation – companies that are all about innovation and unmet need will naturally align themselves with governments and healthcare systems with the same values. The government has done a lot of work to understand how to position the UK as a hub for the life sciences industry, and the Life Sciences Industrial Strategy is a great output of this. It now needs to be implemented.
Currently we are running 78 clinical trials in the UK across a range of areas including HIV, cancer and liver disease, involving almost 2,000 patients. This is a reflection of the strong science base in the UK, and the good scientific and academic institutions – we hope to continue this strong relationship and investment.
Gilead is mainly known as being active in HIV and Hepatitis C. What are the specific needs and characteristics of those disease areas in the UK?
Both HIV and Hepatitis C are infectious diseases that often touch disadvantaged populations, probably even more so with Hepatitis than HIV. Therefore, we as a company have to consider not only how we make our medicines available to the NHS, but also how we partner and work with the NHS and other stakeholders to make sure that the patients in need of our medicines are actually getting access, and access in the right way.
In any communicable disease, we have found that real benefits are reached when we engage the patients in the care process but also when we take an epidemic approach to the disease and thinking about it in terms of elimination. Particularly in Hepatitis C, where you can treat to cure, you truly have the potential to eliminate the disease. That is a huge benefit to the healthcare system in the longer term. But in order to do that, you have to be able to engage patients who may not be engaging with healthcare at all. These patients often have a broad range of health and social issues and see this disease as something relatively low in terms of priorities. Thus, to raise awareness, we need to partner effectively with the NHS and find new ways to make medicines available, and this is when we will see most success on the path to elimination.
Access to medicine for all populations is extremely important. Where do you see the UK stand in terms of collaboration with the industry and providing access for patients in need?
It is a general truth that countries have to—and should—manage carefully their medicine spend. Each country has its own way of doing so, but I think the best approach is to look at this from both a short-term and a long-term perspective A short-term perspective in terms of how you make medicines available to patients as fast as possible, and a long-term perspective in terms of how you effectively support the industry to continue to invest in the areas of highest need.
If medicines are priced at the value that they represent to the healthcare system, this enables industry and its investors to funnel investment towards the areas that represent high unmet need. In the end, I believe this is the right way to price medicines. There is no perfect price, but there are systems in place to get as close as possible to that goal and reach an agreement.
It is Gilead’s mission to develop innovative treatments in areas of high unmet need. Nobody comes to work in a pharma company wanting to develop a ‘me too’ medicine – everyone wants to find a cure for cancer. However, we need this innovation to be rewarded in order to be able to continue to invest in tomorrow’s innovation and deliver to patients in the longer term. We hence see it as imperative that countries have value assessment and procurement approaches that utilise medicine spend to support investment into innovation and reward innovation.
The issue we sometimes see in the UK is that different stakeholders within a complex framework add new processes to the overall chain of medicines value assessment and procurement. Each individual believes that they are adding value by making savings to NHS budgets. But when you layer up these processes from the various different silos, you can find that they start to have negative impacts – not only for innovation and for patient access, but also for overall budget control. So the health system overall spends more and gets less in terms of benefit. All stakeholders need to remain focused on what really matters to patients, clinicians and society. The UK has an excellent process through NICE to assess the value of a medicine to the healthcare system. It’s not perfect, but it’s a good way of aligning pricing and spend to bring value. It helps us to appropriately value incremental innovation as well as transformational innovation. Both of these are important!
By contrast with a more procurement-driven approach, it is always easier to target more highly specialised innovations. Ultimately this is an issue because it drives the industry in the wrong direction in terms of investment. The industry may want to innovate, but will not have the means to do so anymore.
Have Gilead’s past experiences with Sovaldi® better prepared the company in terms of communications and building relations with the system?
I think that the economics of cure is a complex and poorly understood topic. Healthcare systems are used to dealing with annual treatment costs associated with chronic treatments. The cost is divided into chunks and multiplied over the life-cycle of the patient for the duration of that drugs’ patent.
With our treatments in Hepatitis C, the logic changed completely: suddenly, the treatment was a cure. If you looked at the price over the course of a patient’s life it was very low, and even as a one-off it was similar to the existing options for those patients. But healthcare systems struggled with the potential for a high number of patients all looking for treatment at once. It was a unique situation and required a unique approach. In some countries we managed this very quickly, following constructive two-way discussions with the system to find solutions that worked for patients and the healthcare systems.
What can we expect from Gilead’s pipeline in the future?
The nearest innovation is in the area of cell-therapy for oncology. This is the ultimate of personalised therapy, taking the patient’s own immune cells and re-engineering them to fight their disease. This is the beginning of a journey that has the potential to transform the way we treat and think about cancer in the future. We are also currently heavily investing in inflammation, an area that many perceive as being well understood and covered, when in fact it still represents huge unmet needs. We are working in NASH for which awareness in the UK is very low. Many see liver diseases as a result of alcohol consumption when obesity is actually just as important a cause. Indeed, the three main causes for liver disease are alcohol consumption, obesity and viral diseases. As we are already extensively covering the viral diseases part, we are now increasingly considering obesity, as it is responsible for just as many cases as viral factors and alcohol consumption.
We have seen a measurable decrease in the number of liver transplants resulting from viral hepatitis, both Hepatitis B and Hepatitis C. Gilead has been able to truly change the landscape of the disease and now target another factor to achieve the same. In HIV, we consider there is still a long way to go as well, especially when it comes to patients ageing with the disease. Medicines have to be better suited for people with the co-morbidities that an aging HIV population has. Gilead still pursues and will continue to pursue the goal of elimination or a cure for HIV.
Is there a message that you would like to send our global audience on the UK and Gilead in this country?
The UK is an important country for Gilead, not just because of its size as an attractive pharmaceutical market, but because of the power of the UK to shape and influence trends across the world. The UK has a tremendous science base and a thorough understanding of how to value healthcare innovation. This makes us uniquely positioned from a global perspective.