PharmaTimes talks to Hilary Hutton-Squire, vice president and general manager of Gilead Sciences in the UK and Ireland, about the importance of valuing medicines in the right way

What do you think are the key challenges and opportunities for the pharma industry in the UK?

While Brexit is seen as a key challenge to all sectors, it has focused minds on the importance of the life sciences industry to the UK economy, and the need to ensure that UK patients continue to access the most innovative new treatments without delay. Alongside this, we are entering a new era for innovation in healthcare and NHS patients were among the first in the Europe to access CAR T treatment, which was approved in record time.

With the current review of NICE’s methods there is the opportunity for a more flexible approach to assessing medicines and fast-tracking the most innovative ones. As innovation in health gathers pace and more personalised, targeted treatments become available, ensuring the UK healthcare system is equipped to deal with them post Brexit is crucial.

Is there potential for a closer working relationship with healthcare services?

The advent of personalised medicines means that close collaboration between the pharmaceutical industry, NHS England and services is vital. The sheer complexity of these innovative treatments has put the entire healthcare system to the test – from how we assess and reimburse them to how we make them available to patients.

What we’re now seeing is parties coming together with a shared goal of making certain new medicines available in the UK as quickly as possible, but we need to ensure that the system has the flexibility to handle innovative medicines in the future. The inevitable challenge will only be met by keeping the emphasis on how all parts of the system can work together to achieve this.

What are your thoughts on new plans to fast track ‘game- changing’ new cancer drugs in the UK?

The plans to fast-track these new treatments indicate just how much of a priority they are for NHS England and the need for a new approach to making them available.

When NHS England and NICE approved CAR T therapies for use on the NHS last year in record time, it signalled the potential for a new approach to engagement between government, industry and the NHS. But as more personalised treatments start to become available for different indications and bigger patient populations, they will inevitably raise new questions about how we can sustainably deliver them and without causing delays to patients. So, it’s very encouraging to see NHS England recognising the challenges they pose and considering how to work with the pharmaceutical industry to overcome them.

What are the practicalities of implementing this ambition?

The key considerations for fast-tracking new, highly innovative treatments are: how do we appropriately assess their value? How do we ensure the system is equipped to deliver them? And how do we achieve this in a way that encourages future innovation?

For me, collaboration and flexibility lie at the heart of this. CAR T is only available now because the NHS, industry and healthcare leaders came together to make it happen, and this partnership approach will be essential to building on that initial success.

Personalised treatments are highly complex to manufacture and deliver, but have the potential benefit of being a one-off treatment. As such, current assessment processes run the risk of either overplaying the downsides to the treatment or not fully recognising the potential benefits. Additionally, because these treatments are so new, assessing their long-term impact can be difficult. When there are currently so few patients receiving the newest treatments, capturing their lived experience is as crucial as it is challenging.

When valuing personalised treatments, we need to strike a balance that considers the initial cost of getting the system set up to deliver it alongside the costs of manufacturing a treatment tailored to each patient. This means that manufacturers are very limited in how far they are able to go to meet the NHS’ affordability threshold. If the price is too high, the NHS just won’t be able to afford it but if it’s too low then it will disincentivise future investment in innovation.

What are the greatest limitations of NICE’s current appraisal process for NHS funded medicines?

One of the most significant challenges we currently face is flexibility. The current appraisal process was set up more than 20 years ago, at a time when mass-produced treatments for large patient populations were the norm, so having a fixed threshold for cost calculations made more sense. Over the years, NICE has introduced certain modifiers to these approval thresholds, such as end of life criteria. Now, with the advent of personalised medicines, there needs to be a way to consider how this threshold can flex in order to better reflect the individualised nature of these treatments and the value they represent to patients and society.

The other major limitation is how to fully capture the value these treatments hold for patients and society and ensure this is factored into appraisals. In many cases, personalised medicines will initially be for patients who have run out of options and may only have months to live. The current framework is skewed towards calculating the cost based on clinical trial data and the overall benefits to the total number of eligible patients. So, the question is: how do you capture the true impact of a treatment on a patient who may not have otherwise survived?

Personalised therapies may be seen as expensive, but consideration needs to be given to their potential to transform the patients’ lives. Ensuring that patients and clinicians have a greater voice in the assessment process is essential if we are to truly reflect the impact of personalised therapies and ensure patient access.

How can the system be modified to ensure equitable and affordable access to new medicines on the NHS?

Fair patient access to medicines is always the highest priority and the current review of NICE’s methods represents a great opportunity to ensure that this is achieved affordably. Personalised therapies are a gamechanger – one-off interventions, usually in areas of high unmet need, which hold the potential to cure patients. It is likely, therefore, that the public will expect access to these and the system needs to address how it can affordably meet this demand.

By next year, it’s estimated that 75% of new cancer treatments will show effectiveness for more than one tumour type. Yet inflexibilities in the current system mean only one price may be offered per treatment, so the risk is that some treatments may not be deemed affordable for the NHS for certain indications.

As an industry we must do better to explain the value we bring to patients and society, our investments in innovation and our pricing regimes.

What do you feel has been your greatest professional achievement in your role?

My focus has been to make Gilead an organisation which enables its employees to address high unmet need. From launching cures for Hepatitis C to making HIV a chronic condition that’s managed with a daily pill, I am incredibly proud that our work is having a real impact on people and communities.

What has been your greatest frustration?

For anyone working in pharma, one of the biggest frustrations will be how the industry is perceived by society. We know how much of a difference we can make to the lives of patients, but all too often it can feel like our role is misunderstood.

The UK has a fantastically strong life sciences industry, worth around £70 billion to the economy each year, employing nearly a quarter of a million people across the UK. Almost everyone will have used a medicine that has been developed, tested and brought to patients by a pharma company.

Despite this I am often surprised when talking to a wide range of people how few are aware of industry’s investment and the major breakthroughs in treatment.

To begin to address this, we as an industry need to do much better in explaining the value we bring to patients and the R&D investment required to bring new drugs to market. Without investment, innovation will stall. Getting this right also means the industry and the NHS need to work together in new ways – to partner in the cause of human health.

Does pharma need to change how it measures and demonstrates the value of innovation?

Yes. We are an industry that improves healthcare through a ‘for- profit’ model – and that’s a tremendous responsibility for us to hold.

However, we need to do a much better job of explaining the value innovative medicines bring to patients: how a medicine actually comes to market, the science, the research and development, the clinical trials, the regulations that are in place to ensure that all medicines are safe for patient use; the list goes on.

Medicines must be valued in the right way. Too high and health systems can’t justify the investment in the here and now. Too low and we risk stifling development in areas of unmet need for the future.

I’m incredibly proud to work in an industry that continues to play a key role in improving patients’ lives - let’s all remember we need to share that story.