Richard Erwin, general manager of Roche Products Ltd in the UK, speaks out about the challenges facing the company, from market access to uptake of innovation, to collaborating with diverse stakeholder groups, improving outcomes for UK patients.
What is the scope of operations of Roche in the UK?
On our site in Hertfordshire, Roche hosts four key functions. Our Early Research and Development function is responsible for Roche compounds in very early translational research. A small group of people from Genentech Early Research, as well as our Pharma Development business, deal with later stage development for compounds from both Roche Genentech and our Japanese partner Chugai. Finally, we have business units dealing with clinical trials, access and uptake of our medicines.
Roche has been investing in the UK for 110 years and will continue to do so. It’s one of our global Roche centres where we have early research and development activity. Our most recent figures from 2016 showed that we contributed £1.1bn to UK GDP, supporting more than 18,000 jobs, and registered more industry-sponsored clinical trials than any other company.
Why did Roche choose to invest in the UK?
I think there are two reasons why Roche has been committed to the UK. Firstly, there’s great talent here, we are able to attract and retain the best staff. Our people are ultimately what make us a great company. Secondly, the UK has some of the world’s greatest institutions across science and clinical medicine and it’s great to be able to access that expertise.
The UK is known to be a challenging market. How has that impacted your role of general manager?
For many, the UK market is seen as one of the most challenging in healthcare. Not in terms of sheer size, such as the US or China, but in terms of market access and uptake of innovative new products. In Germany, for example, access is often rapidly granted, and uptake of innovative breakthrough products guaranteed; however the UK ranks low in international comparisons for access to new medicines. Sometimes, even when access is granted, uptake can be slow.
My mission is to therefore to drive patient access and uptake. Roche measures its success according to the proportion of UK patients our drugs are reaching and improving health outcomes.
What is the role of a company like Roche when it comes to communicating with stakeholders to improve access and uptake?
Whilst it is easy to criticise failings in the system, and some criticisms are valid, I am passionate that we work within it to ensure patients are able to access the best treatments available. Therefore I do whatever I can to come to the table with solutions, looking for all stakeholders to do the same, so we collaborate to achieve what’s best for UK healthcare.
Consequently, as a company, we have to prove our commitment to patients. Usually, this is only feasible through compromise. Recently we have come together with NICE and NHS England and been able to find solutions that suit everyone. So I am more confident today than ever when it comes to access to medicines in the UK.
Having said that, things are far from perfect. We do ask how a country like the UK can justify having some of the lowest thresholds for ICER (incremental cost-effectiveness ratio) amongst developed nations. As a British citizen, I find this unacceptable; the value the UK places on a year of life gained is one of the lowest in the developed world.
Despite all this, NICE is a world leader, and I believe that by collaborating we can find solutions. From an industry point of view, some topics like more flexible ICER thresholds need to be addressed. Especially for those companies like Roche that bring in real innovations, first-in-class medicines, where the standard of care is ineffective and no real comparator treatments exist. The current ICER thresholds are challenging to navigate. In some cases we have offered free access to our medicines, but this just isn’t a sustainable business model.
Roche is an experienced negotiator, prepared to consider our medicines’ prices, but we expect the same flexibility from the system. I think we need to hear more from all stakeholders in health, to get more serious about health in the UK. Industry, therapy area experts, healthcare professionals and the general public need to let politicians know they want a truly world-class healthcare system, fit for all.
Do you have any examples of success, where the UK has shown it can find solutions?
There are few areas, perhaps in generic and biosimilar uptake, where the UK excels when compared internationally. But I think we have to ask ourselves: are those the only areas we want the UK to succeed in? Do we not care about the areas of medical breakthrough and real innovation?
Slow access can often lead to poor uptake. Therefore, when we collectively try to improve access, especially early access, we will start to see uptake and outcomes improving for patients.
Nevertheless, I think we should take the time to recognise success when things have worked well. The Cancer Drug Fund is one such example, and NICE now often assesses oncology drugs in parallel with the regulatory approval process, which speeds up the whole procedure. One focus of industry should now be to push for such models to be considered for other therapy areas.
One can see vast differences between disease areas. If you consider lung or colorectal cancer, outcomes are below where they should be, but the UK has improved outcomes in breast cancer from a below-average level to one in the top quartile. Of course, this is not down to medicines alone but also the result of co-ordination and commitment across institutions, from screening to surgery. We do see a will and an intent from stakeholders, from the government to physician groups, for the UK to be a global leader in life sciences. This recognition is the first step in the right direction for the UK’s incredible potential to unfold.
Within Roche’s portfolio, three of its major cancer drugs will be coming off patent soon and are about to face biosimilar competition. At the same time, Roche boasts a very rich pipeline with about 15 molecules in late stage development. What will be next in your UK portfolio strategy?
The patent cliff we are facing did not take us by surprise and we have thought carefully about it. We took the decision not to compete in the biosimilar space, as we’re a company focused on innovation.
In the UK, we will be extremely busy over the next two years launching seven to eight new products. We are innovating in multiple therapy areas including multiple sclerosis lung cancer and haemophilia, hoping patients in the UK will be able to benefit from new treatments this year. In oncology, we recently obtained an additional license in HER2-positive early breast cancer and hope to navigate it through reimbursement later this year. One of our new cancer immunotherapies is also looking at approval across several indications.
Therefore, while a significant part of our revenues is at risk through biosimilar competition, we are in an incredible position to meet this challenge. Thanks to our pipeline, no company is better placed than Roche to adapt to the changing environment. It’s worth stating that so far in 2018, all eight of the submissions we made to NICE and NHS England were successful, so we have had a fantastic start.
Roche is a pioneer in personalised healthcare. How do you see this new approach to patient treatment evolve in the future?
Roche is the first company to start on the journey towards targeted medicines. We remained committed to identifying new solutions for patient treatment and positive outcomes. Our vision for the future is that every cancer patient will have their tumour genetically profiled. This will allow for more accurately-tailored treatment and clinical decision-making. For example, if it can be predicted a patient will show no response to chemotherapy, we can avoid exposing them to unnecessary toxicity.
Through our acquisition of Foundation Medicine Inc. (FMI), we are in a leading position when it comes to building up the next generation of personalised medicines. FMI is really the world leader in its field, an FDA-approved and endorsed system. It all boils down to helping physicians make better decisions. Within the next five years, there will probably be a recommendation based on genetic sequencing for every tumour. Through FMI, our focus is on paediatric and rare cancers, as well as CUP (cancer with unknown precedent), especially in lung cancer. CUP is extremely difficult to treat as the origin of the tumour is unknown. However, if the makeup of the tumour can be profiled, it can be treated, by Roche products or those of our competitors.
The next step in personalised medicine is big data management. What we need is regulatory-quality real-world data. The only company in the world able to deliver such data today is Flatiron, which is why Roche acquired it earlier this year. Roche has a dream for the future, linking all cancer centres globally through data. We strongly believe this will be the key to achieving the best patient outcomes. It will be revolutionary; even the need for clinical trials could diminish, as physicians will have tools that will allow them to know precisely which treatments patients will respond to.
Does Brexit go beyond being a major challenge for the UK?
From a business point of view, we have to accept the Brexit decision and work to make the most of it.
The impact on Roche is likely to be limited. We manufacture in Switzerland and the US exclusively, so we are already importing our products from a third country with very high-quality standards. Our role in the UK consists in ensuring we have continuous supply and we are confident that, by working closely with the government, this can be achieved.
I do however have to fight for investment at headquarter level. The UK will never be the first on the map of any CEO, as it accounts for just two or three percent of global revenues. Nevertheless, if we are able to demonstrate that the UK is a country committed to the health of its people, then we are in a different position altogether. We’re moving in the right direction. I am convinced it is hugely important that government listens when British business points out what has to be improved. We are in need of a committed plan, and the Life Sciences Industrial Strategy was a start, but it is just a start.
Roche has been committed to the UK for many years and will continue to be committed to the country, enabling us to ensure that patients get the best access to medicines.
