A lot can happen in 20 years. In the two decades since the millennium we’ve seen the introduction of the smartphone, broadband internet, and the growth of social media from start-up to perhaps the most powerful industry on Earth.
In medicine, too, the change has been dramatic. Twenty years ago, the Human Genome Project unveiled the first rough sketch of our complete genetic code – today this fundamental science has helped to usher in gene therapies which have transformed the way patients are treated across a wide range of disease areas.
The arrival of increasingly personalised therapies, together with the development of new manufacturing and quality control processes, has made it possible for the first time to tackle some of the greatest healthcare challenges that face society. In certain conditions that were untreatable two decades ago, the clinical focus has shifted from caring to curing. As all these developments became a reality, regulators started to change their processes to keep pace and consider new and different types of evidence as part of their appraisals.
Yet in the past 20 years, the systems that determine how new treatments are assessed for reimbursement, and whether they should be provided to patients or not, have remained exactly the same in England. Innovation in healthcare is accelerating year on year, but the system does not seem to be keeping pace. Just earlier this month, the Institute of Cancer Research highlighted in a report that the higher the level of innovation of a cancer medicine, the longer it takes to receive a successful appraisal and availability on the NHS.
The current National Institute for Health and Care Excellence (NICE) Methodologies review represents a unique opportunity to address this.
NICE is a world-class institution, which has a role to play in prioritising truly innovative technologies. A meaningful change is necessary to keep the UK life sciences industry focused on the areas of unmet need. As well as just ensuring that therapies can reach patients, by emphasising innovation and increases in quality of life, NICE can help drive global research and development investment towards areas of high unmet need. At the same time, change can enable the system to cope with changing trends in innovation, and be more open, transparent and predictable when it comes to its decision-making, particularly when it rejects medicines.
From a global perspective, the pharma industry is watching for signs of real progress, to be able to make the case internally for continued and increased investment and the prioritisation of the UK as a market. What do we mean by meaningful change? There are several examples across the world of how countries are pulling ahead in the race to improve their cost-effectiveness processes. In the Netherlands, for instance, a formal scale has been introduced to ensure that the more severe a condition is, the greater the incentive for companies to invest in treating it. In Sweden, the principles of cost-effectiveness for new medicines are driven not by a blanket rule, but by recognising the impact of a disease, and the availability and efficacy of previously available treatments.
That’s why I was delighted to represent Gilead at a recent Westminster Health Forum conference on the future of NICE in health and social care. For me, the most important part of medicines regulation is getting new treatments through to the patients who need them as soon as possible, but at present, around 60% of therapies are rejected by NICE at the first time of asking. At the conference, it was encouraging to hear from Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE, acknowledging the new era of medicine and NICE’s aim to reverse the trend of higher rejection rates to ensure more treatments are approved in a timely manner – indeed, he specified a target of 80% at first point.
As an industry, we need to find a way of working with regulators like NICE to make that ambition a reality. The NICE Methods Review is one part of that process, but trust, openness, flexibility and a willingness to compromise on both sides will also go a long way towards delivering the changes that industry, healthcare professionals and, most important, patients need.
For this transformation in treatment and care to take place, partnerships are key. Industry and health technology assessment bodies like NICE, as well as the NHS, are going to have to review their wider engagement when assessing new treatments.
We must address the way that we currently engage with the charity community in the HTA to ensure the lived experience of the patient is also considered alongside the clinical and economic case for medicines. We must learn from our colleagues in Scotland who take a different approach with the PACE process, whereby charities and patients feel supported, valued and included in the final decisions.
Only by doing that can we continue to bring innovative medicines to those in need, and thus gain public trust and confidence that providing access to the best medicines is our common priority.
The life sciences industry is worth around £70 billion to the UK, but the reality is we are in a global competition for innovation. If the UK is to cement its position as a hub for the industry, we must work together to make the UK the most attractive place in the world to bring new treatments to patients and a place in which companies can invest and operate. New modifiers that recognise the severity of diseases in the HTA process could help position England as a leader in this area and ensure patients can access the medicines they need quickly.
I also recognise the work that industry needs to do. Gilead has the unique experience of how partnerships can change the treatment landscape, having worked with NICE and NHS England to introduce the first CAR-T therapy for adults to patients across the UK over the last two years. To tackle the challenges around access that this exciting decade of pharmaceutical innovation can and must hold, we will need to work together more collaboratively and flexibly than we have before.
But all too often, the narrative around the pharmaceutical industry is not a positive one, meaning we also need to do something quite radically different to change the way in which people think about pharmaceutical companies. Every day, I see and hear the amazing work that my teams are doing to fight disease, and some of the stories that patients have, their lives transformed by innovative new treatments. We don’t do nearly enough to communicate that value to the public and make our role in the system clear.
The future of medicine is immensely exciting. But to maximise its potential we will need to be unashamedly bold, to be unafraid to make difficult decisions now, and to never take our eyes off the thing that really matters – improving the lives of patients in the UK and across the world.
Hilary Hutton-Squire is Gilead Sciences’ UK general manager
