Oncology

As I took on my new oncology role with GSK in November 2021, and started to review and shape our business plans for the coming years, it struck me how much of a personal, as well as professional, interest I have in accelerating patient access to innovation. And from this I asked myself – where can I make the most positive difference day-to-day? Where can I work with others, to identify and solve some of the biggest challenges that currently result in UK patients often missing out on the widespread use of new treatments that we see elsewhere?

Not only do I work for a large UK-based global healthcare company, but I’m also a UK citizen with a UK-based family, with many of my closest friends and family here. We will all be impacted by medical advances in this country in our lifetimes. These advances rely on previous advances, and those on developments that came before, and so on. The faster we move today, the faster we will all see the benefits tomorrow. And from this, the widest possible health improvements will be felt by the widest possible number of people in the UK.

Of course, the UK is in a strong position to create fast access in the initial development and deployment phases of new treatments. The opportunities afforded by accelerated marketing authorisation initiatives, such as Project Orbis for oncology and the Innovative Licensing and Access Pathway (ILAP), are underpinned by strong commitments in the UK Government’s Life Sciences Vision. We have internationally renowned institutions, such as the MHRA, and in the NHS we have world-leading specialist centres and pioneering ambitious trials. The UK remains a key market for new approaches to the very concept of how we treat patients in the future, such as in immunology, or in potentially curative cell and gene therapies. In the early development phases of innovation, the UK is well-positioned to compete with investment against comparator economies. If the most positive difference for patients is in trialling and proving concepts here, then we can be confident that GSK and the wider industry are well-equipped to continue to play our part.

However, when bringing approved innovative medicines to NHS patients early, companies are increasingly working in a system driving towards ‘budget-neutrality’. There will always be the case for bespoke agreements in early access – be that due to unmet need or to improve clinical practice, where commercial return is minimal. The question is, will seeing this model become the norm create the biggest positive long-term difference for patients?

As a potential beneficiary of innovations in my personal life, I also look to the mechanisms that are set up to ‘bridge’ from concept to the patient, such as the Cancer Drugs Fund (CDF), the proposed Innovative Medicines Fund, and early access schemes that are in partnership with the NHS. The purpose of these is to try to make the most impactful, earliest, positive difference, in order to create a gateway from accelerated licensing routes, through managed or conditional access, and eventually into the NHS, and to provide hope for all patients; not just those in a trial or in the early access scheme itself. In this area, the biggest difference we can make to accelerated routine patient use is to do everything we can to ‘de-risk’ or share risk – risk that the treatment may not prove cost-effective, or risk that it may simply be unclear after a defined period of time (high-cost lifetimebenefit treatments, such as in cell therapy, could be cited here). Sharing risk could mean looking at new outcomes-based models, new funding vehicles, or expanding value assessment measures to encompass a wider range of data.

The CDF has been a success in terms of facilitating early access where evidence is not immediately clear, or data is incomplete. This relies on the Health Technology Appraisal (HTA) model accepting a level of uncertainty, but has perversely led to an increasing reliance on the CDF as a default access route for oncology innovation. Is the biggest positive difference we can make expanding the budget pot for CDF? I am sure that would be welcomed by many. Or could the biggest positive difference be creating the right environment to bring routine access through standard HTA processes, so that eventually we will not need a CDF?

Which leads me to think, are we actually missing the main goal? So much focus across the various strategies and system levers is on that initial early access, yet the real success measure here, and the biggest difference I feel we can make for patients, is in gearing every system lever towards the fastest and broadest eventual uptake. Whether a fast-track or more standard route to patient access is chosen, if all eligible patients are not benefitting from a technology as quickly as possible, then we have collectively failed.

I am acutely aware this is not a new insight. The 2019 Voluntary Scheme for Branded Medicines Pricing and Access makes improved patient uptake a key success measure. But three years on, we remain faced with the same challenge. We need to stress-test each and every system mechanism against how it is contributing towards rapid routine use and, if not delivering on that, then it needs to be reformed or replaced.

We must together support reforms to make the UK as good as, or better than, comparable global economies in uptake. We must learn from other markets, and not be too protective over our own approach. Indeed, the UK’s global leadership in so many areas of healthcare exists because we learn and grow from collaboration, and not because we feel our system and approach is always best. When we look at the better rates of innovation uptake in markets such as Germany or France, what are they doing differently that we can apply in the UK? In our access system, how can we improve the existing successful concept and early access models so that broad patient use is better prioritised? How can we move beyond default conditional access, whether that is fast-track appraisals, or reimbursement models that reward those that widen access and prove value in a real-world setting?

Faster use of innovation can deliver obvious population health benefits with all the knock-on positives in quality of life, and a reduced NHS burden – so there is a strong economic incentive. Faster use by patients also generates incredibly helpful data in the UK, which can subsequently be used to deliver more innovations, ahead of other markets. Real-world data will also help us see whether innovation is appropriately valued. In this, the industry has to accept that an initial assessment could be revised up or down. If trial data does not apply to the real-world setting, then that treatment is not making the difference that we believed it could.

But what else can I do? I will ensure that when relevant data is available, or when a treatment is reimbursed, our teams are out there on day one, ensuring that every possible clinician has the information they need to assess whether it is suitable for their patients. We need to ensure that our education and support materials are as clear and relevant as possible. We need to understand from colleagues in the NHS the system barriers that are preventing patients using approved treatments where they are suitable – and where possible, help to remove them by partnering on solutions.

Every day I see the amazing progress the UK makes in life sciences, and across the health system, for each and every patient. If we made the biggest difference tomorrow, then there would be another big difference to make the following day. It is not easy to meet the challenge when new obstacles will inevitably follow, but progress simply has to be made. There needs to be a willingness to disrupt our systems and processes, even if that means making hard decisions. There needs to be system investment, and a shared focus across all stakeholders that can help realise this positive difference for patients. To deliver this, we must centre all pathways towards a success measure of the highest possible patient uptake, and this is a challenge worth our time.