The UK market access environment faces a time of change – the result of the convergence of several major drivers of reform. The COVID-19 pandemic will reinforce trends that were already taking place. The NHS in England is in the process of yet another fundamental reorganisation. Brexit has precipitated significant adjustments to the UK regulatory system. The National Institute for Health and Care Excellence (NICE) is poised to undergo an overhaul of its methods and processes.
In addition, the government has recently published a Vision for Life Sciences that seeks to improve collaboration between different stakeholder groups in the healthcare ecosystem. For its part, pharma will need to be more adaptable than ever to adjust to this fast-changing environment.
Repercussions of the pandemic
The pandemic has undoubtedly had a dramatic impact on the NHS over the last 18 months, and it will be a catalyst for lasting change in the healthcare system. Experience with telemedicine, combined with the growth of digital health technology, will accelerate a pre-existing trend to move care out of the inpatient setting where possible. For example, the NHS has indicated that initial funding of £160 million to substitute 50 ‘COVID-friendly’ cancer therapies – oral drugs and more tolerable treatments – for traditional chemotherapy in hospital could be maintained until March 2022.
Of course, the government will soon have to deal with the enormous cost of dealing with COVID-19 and its consequences. Pharma is understandably anxious that it could be a prime target for cost containment. However, the pandemic has enhanced the industry’s reputation and powerfully demonstrated the importance of investing in healthcare.
The human cost of the pandemic is, of course, enormous. Delays in the diagnosis and/or treatment of some diseases – especially cancers – will harm the prognosis for many patients and have implications for their therapeutic options. It will be interesting to see if treatment algorithms might be relaxed to take account of these delays. The NHS will also have to deal with the challenges of ‘long COVID’ and an increase in mental illness.
“The pandemic has enhanced the industry’s reputation and powerfully demonstrated the importance of investing in healthcare”
The shift to integrated care
The Health and Care Bill will introduce the latest in a long line of reforms of the NHS in England. At its heart is a shift towards integrated care – breaking down the barriers between healthcare and social care to improve population health. The 106 clinical commissioning groups (CCGs) are expected to be merged into 42 integrated care systems (ICSs) by April 2022.
Pharma will have to adapt to new decision makers, including influencers in social care. The scope and composition of area prescribing committees may change. Some hospitals have been directed by NHS England to form hospital groups, with potentially significant implications for procurement. Each ICS is expected to have a ‘single pot’ of money for commissioning, primary care budgets and specialised commissioning, diminishing the financial independence of individual hospitals.
Hospital reimbursement will move away from the current activity-based approach to ‘blended payments’ that combine a fixed sum based on the costs of delivering a specific level of activity with a variable component for certain elective activities. Many high-priced drugs are expected to be purchased by ICSs based on cost and volume, but NHS England (NHSE) has suggested that blended contracts and local negotiation could be used for biologics to make providers more aware of the cost of these drugs. Most specialised services will no longer be commissioned by NHSE but by ICSs or groups of ICSs.
Impact of Brexit on the regulatory environment
Following the UK’s departure from the EU, the Medicines and Healthcare products Regulatory Authority (MHRA) now has exclusive responsibility for licensing medicines. However, the UK government has elected to join two international regulatory alliances to expedite the approval of new drugs. The Access Consortium brings together the regulatory agencies of the UK, Australia, Canada, Singapore and Switzerland, which hope to be ‘regulators of choice’ for the launch of new drugs. Project Orbis – an alliance of the UK, the US, Canada, Australia, Switzerland, Singapore and Brazil – has a narrower focus, on oncology drugs. The first result of Project Orbis was the MHRA’s approval of a label extension for AstraZeneca’s Tagrisso three weeks before the European Commission granted the same authorisation.
Major changes at NICE
Twenty-two years on from its formation, NICE sees a need for major changes to its methods and processes. The reforms are scheduled to be finalised by November 2021 and implemented in January 2022.
Key proposals for potential changes at NICE:
- Replace the current modifier for life-extending treatments at the end of life with a broader disease severity measure.
- Potentially terminate guidance development if the base-case incremental cost-effectiveness ratio (ICER) is too high.
- Accept a greater degree of uncertainty and risk in some circumstances.
- Fund interventions with greatest benefits and disinvest from low-value/ineffective technologies.
- Be more receptive to real-world evidence, particularly for
- Allow one-off treatments to be classified as highly specialised technologies (with a much higher cost-effectiveness threshold).
- Encourage fast-track appraisal for drugs entering established therapeutic classes.
- Streamline the evaluation of drugs with multiple indications.
- Move from HTA to health technology management, with “living guidelines”.
- Involve patients in the selection of outcomes measures.
Gillian Leng, NICE’s Chief Executive, believes the most significant proposed change to NICE’s methods will be the adoption of a wider range of modifiers. Addressing uncertainty will also be very important because of plans to accelerate access and broaden funding for some innovative medicines.
The institute’s recently-published Strategy 2021–2026 notes that “there will be an increased push for integrated guidelines that extend across the health, social care and public health interface. They will need to have a stronger focus on prevention and reducing health inequalities, particularly in key priority areas including the ageing population with increasing co-morbidities and the underlying risk factors driving growth in noncommunicable diseases.”
“The government sees the value of an innovative pharmaceutical industry in the UK and wants to ensure the country is attractive to manufacturers from around the world”
Government’s Life Sciences Vision
In July 2021, the government published its Life Sciences Vision. Its stated ambition is to “make the UK the best place in the world to discover, develop, test, trial, launch and adopt new treatments and technologies, by creating a forward-thinking commercial environment where the NHS can strike flagship deals and where proven, clinically and cost-effective innovations are rapidly adopted and spread across the country to bolster the health of the nation, deliver greater value for the taxpayer and stimulate economic growth.”
The NHS Commercial Framework for New Medicines will play a key role in fulfilling this ambition. It is intended to “encourage faster market entry for new treatments and support uptake and adoption where these medicines are priced fairly and responsibly.”
Table 1. NHS Commercial Framework for New Medicines outlines terms for managed entry
NICE to work more closely with academic health science networks
NICE has formed a new collaboration with England’s 15 regional Academic Health Science Networks (AHSNs) to “support the use of the best evidence-based healthcare in the NHS to improve the lives of patients.” The two-year agreement will promote the development of the Accelerated Access Collaborative’s National Innovation Service, which aims to create a single front door for innovators. The goal is to speed up the adoption of innovative health interventions (including digital health technology) throughout the NHS and to generate real-world evidence to underpin NICE recommendations. Closer partnership between industry and the NHS is a key objective of the AHSNs.
NHSE is particularly interested in exploring opportunities for ‘smart deals’ that offer companies market access within weeks (or sometimes days) of marketing authorisation in return for a substantial discount and a commitment to collect real-world evidence (RWE) for evaluation by NICE. Novartis’s Kymriah, Mayzent and Zolgensma, and Kite’s Tecartus, are examples of drugs that have benefited from such deals.
The government has also recently unveiled England’s long-awaited Innovative Medicines Fund (IMF). It will have an annual budget of £680 million—half of which will maintain the existing £340 million allocated to the Cancer Drugs Fund, on which the new fund will be modelled. The IMF will be available for treatments for all pathologies, though rare and genetic diseases are likely to be priorities.
A further initiative to expedite access to novel therapies is the Innovative Licensing and Access Pathway (ILAP), which will give companies the opportunity of very early engagement – potentially at the pre-clinical stage – with key players in the UK healthcare system, including the MHRA, NICE, the Scottish Medicines Consortium (SMC) and NHSE.
Outlook and implications for pharma
The UK’s dynamic access environment will undoubtedly present challenges to the pharmaceutical industry, but it also offers some exciting opportunities.
Table 2. Actions to be considered in response to changes in access conditions
In the wake of the pandemic, vaccines and treatments for infectious diseases will inevitably benefit from increased support. Therapies for chronic, high-prevalence, non-communicable diseases will also receive greater attention. Boris Johnson has specifically mentioned the need to tackle obesity. The Life Sciences Vision goes further, identifying treatments for neurodegenerative disorders, cancer immunotherapies, novel vaccines, cardiometabolic therapies, treatments for multi-system ageing and therapies for mental illness as priorities for funding. Given that budgets are finite, other medicines – possibly including orphan drugs – may face more challenging access conditions.
The combination of the pandemic and the reorganisation of the NHS in England will accelerate the shift in care for many conditions out of the hospital setting, though the management of some diseases will inevitably remain the preserve of secondary care and may even be limited to a few tertiary centres of excellence. Pharmaceutical companies may have to adapt their portfolios, recognising the increasing importance of oral and subcutaneous formulations. They will certainly need to develop a more holistic view of care pathways – to engage with a wider range of decision makers and show the value they can offer across the continuum of care.
The UK has long had the reputation of being ‘low and slow’ for the uptake of new medicines. However, the 2019 Voluntary Scheme for Branded Medicines Pricing and Access set a target for the UK to be in the upper quartile of comparable countries for uptake by June 2021. That goal may not have been achieved, but the Life Sciences Vision does suggest that the government sees the value of an innovative pharmaceutical industry in the UK and wants to ensure the country is attractive to manufacturers from around the world.
Historically, the NHS – especially at local level – has often seemed wary of partnerships with the industry, but this situation does appear to be changing. Sir Simon Stevens, the outgoing Chief Executive of NHS England, has said: “When drug companies play ball with the NHS, taxpayers get a fair deal and patients get cutting-edge treatments.”
The industry will naturally want to ensure that the rules of the game are clear, the playing field is level and the goalposts are not moved mid-match. There are, of course, no guarantees, but the outlook for access in the UK does seem more promising than it has in a long time. Companies need to act now to ensure that they are ready to make the most of current and future opportunities.