Pharmaceutical Market Access in the UK: A Changing Landscape

What market access changes have taken place in the UK recently and what are the implications for pharmaceutical companies?

One positive change for pharmaceutical and biotech companies took place in 2021 when the UK government announced its Life Science Vision, whilst not a new development it signals the significant opportunity available in the UK. The vision has four strong pillars that demonstrate the importance the UK government place on the growth and success of the life sciences sector to the overall economy. Two of these pillars are of particular interest to pharmaceutical industry operating or hoping to operate in the UK 1) Make the NHS the countries most powerful driver of innovation 2) Create an outstanding business environment for life science firms, which support growth, innovation and investment. This signals an opportunity for life sciences in the UK to grow and thrive, of course its not that simple but the government intent is clear, making this an exciting time to operate in the UK. A second change took place last year when the NHS enacted a major restructuring, introducing 42 integrated care systems (ICSs) across the UK to replace the over 200 clinical commissioning groups that were responsible for buying healthcare services for their local communities. Health and social care will now be managed together (rather than social care managed by local authorities), which should mean that decision-making is coordinated and the patient experience is seamless. The ICSs will also promote self-care and disease prevention. The introduction of the ICSs shows that the NHS’ thinking about how healthcare is delivered is changing. But, of course, the devil is in the details; pharmaceutical companies may need to engage with each of the 42 ICSs and learn what’s important to them and how to work effectively with them. Pharmaceutical and biotech companies looking to enter the UK market must make sure they understand this new landscape.

Another change with implications for market access took place in 2022 when the National Institute of Health and Care Excellence (NICE), the Health Technology Assessment (HTA) body for England, introduced a severity modifier, replacing the end-of-life modifier. The end-of-life modifier, as the name implied, applied to end-of-life medicines, typically for cancer. The good news is that new severity modifier is broader, and is applicable to a wider range of diseases, this levels up the playing field for cancer and other severe diseases. The severity modifier allows NICE to accept higher ICERs (incremental cost-effective ratio) for diseases that are not fatal but perhaps chronic long-term conditions. Its good news for people living with chronic long term conditions, as NICE may be able to recommend more treatments to support patients.

Finally, NHS England introduced the new Innovative Medicines Fund (IMF), similar to the Cancer Drugs Fund, which targets cancer medicines with clinical uncertainty during their health technology appraisal with NICE. Interim funding can be made available for a treatment for a period of time during which more data is collected with the aim to address the clinical uncertainty, and then the product is reviewed again by NICE and a final decision taken. This will be particularly helpful for rare diseases with small patient populations and small clinical trials where the drugs inherently have clinical uncertainty. The result is that these medicines can be used by the NHS and patients can benefit from them while more data is collected. If pharmaceutical companies have a rare disease medicine in development, they should explore the details of the IMF application for market access.

New policies like the IMF and the severity modifier give the opportunity for new medicines to succeed through the HTA process where they may have struggled or failed in the past. The hope is that these changes will result in more patients benefiting from new medicines.

What are the ongoing impacts of Brexit and the COVID-19 pandemic on market access in the UK?

The two are truly intertwined because they happened at the same time, and the effects continue to be felt. The NHS is the country’s largest employer, but the job openings today are much higher than normal due to both Brexit and the pandemic. Also, the UK has an enormous backlog of people on waiting lists for treatment. These issues have had an impact not only on the ability of the NHS to deliver care but also on the management and operation of the NHS itself. Processes are slowed as a result and collaborating with key stakeholders can be more difficult. We often see new stories of medicine shortages, partly attributed to Brexit, this is concerning to the people who need them and has resulted in price concessions from the government to get these drugs into the country.

One positive result from the pandemic is increased use of online services and moving patient care out of the hospital into a home environment. As these practices have continued, there’s increased need for medical devices and digital health solutions that can be used by patients at home. Another positive was that the Medicines and Healthcare products Regulatory Agency (MHRA) rapidly adapted to become more flexible and fast-moving during the pandemic, striving to approve new medicines to treat COVID and to trial existing medicines for COVID treatment purposes. All stakeholders collaborated, proving that when everyone works together, you can achieve some amazing things.

What should companies keep in mind if the UK market is part of their strategy?

These recent changes make entering the UK market even more complex than before, but there are new opportunities too. If you’re trying to launch a new product into the UK for the first time, you need to understand what route that product is going to take. Is it going to go through NICE? Is it going to go through NHS England’s commissioning policy? Will it be a discussion with each of the 42 ICSs? Or will you target the private market? Unfortunately, you can’t just go to a website and choose a path; you need to engage with people who know the UK market to understand the processes you need to go through.

If you’ve already been in the UK market, you might have knowledge gaps about the current environment, or perhaps your previous understanding is now outdated. Make sure that you’re up to date with the competitive landscape. What products are also coming in the particular disease area? In particular, know who the key stakeholders are; they could include patients, patient associations, nurses, doctors, pharmacists, NHS England, the Scottish Medicines Consortium, NICE, etc. How are you going to appropriately engage with all those stakeholders and understand their perspectives and priorities? This is a must to make your UK market access plan successful so patients can benefit from new medicines as fast as possible.

If you’re looking to enter the UK market for the first time, you should be aware that the cost can be quite significant. There are many costs on route to securing a positive NICE decision, including NICE Technology appraisal fees, potential voluntary scheme for branded medicines, pricing and access (VPAS) payments, budget impact test and possible tendering . These costs decrease the revenue you make from your product. So it’s really important to understand and take advantage of all possible assistance; for example, you might want to apply to the IMF with a rare disease drug. And of course, you need to understand what price you’re likely to get for the product in the UK so that you can do a proper business case and make sure that works out positively.

I can point anybody to the NICE methods guide or the Commercial Medicines Framework for NHS England. Anyone can read these and sure, they are well written will make sense. But it’s the interpretation and real life experience than will identify what b the reality is, and that knowledge comes from experience.

How does Alira Health help companies already in the UK market and those planning to enter?

We help life sciences companies to understand the UK health environment and what they need to do to succeed. We can do many types of projects from NICE and SMC (Scottish Medicines Consortium) submissions, real world evidence, patient engagement, reimbursement and access strategies, market research, and more. We also challenge your thinking if that’s necessary. We bring that voice of experience from years of working in this country and this industry.

Alira Health recently partnered with leading UK market access specialist consultancy Policy Matters to bring our clients the expertise of the very senior and highly skilled team of Policy Matters UK specialists, while having seamless access to the array of Alira Health services we offer including strategic consulting and tailored solutions.

Collaborating and even co-creating with other stakeholders will always be the best way forward. Relationships are really what matters, especially in the UK which is a small world. We have a network of existing relationships that we utilize. We know the players, and we understand and keep up with this fascinating, ever-changing landscape.