NHS England – Written evidence (LSI0114)

NHS England welcomes the opportunity to submit written evidence to the Committee.

As the NHS Five Year Forward View[1] set out, the primary mission of health systems is the ‘triple aim’: to achieve better health and wellbeing outcomes for the whole population; to deliver better quality of care for patients; and to deliver better value for taxpayers within the available resources voted by Parliament. Within that enduring mission, the NHS has very clear short-term service priorities: manage our budget; achieve our accident and emergency goals; sustain and improve primary care; and improve mental health and cancer services.

At the same time, the NHS also recognises the major dependencies and impacts it has on other societal goods, such as economic growth, scientific discovery, community cohesion, employment and education. It is within that context that this evidence considers the NHS’s rich relationship with the life sciences sector.

Sustaining and improving the NHS partly involves inventing, adopting and spreading innovative pathway changes, technologies and medicines. We see this translate into better care outcomes for most major conditions. For example, one-year cancer survival rates, and reductions in deaths from heart attacks and strokes, are substantially better than 5 years ago. In turn, for the UK life sciences sector to thrive, it depends on close collaboration with its NHS partners: to understand what they want and need, and help solve NHS problems in a mutually beneficial manner.

One lens through which to view health and care innovations is whether they are ‘additive’ or ‘substitutive’. Many innovations are new individual components that may get layered on top of existing services. Lots of life sciences businesses naturally wish to sell ‘additive’ innovations to the NHS, because they have developed a specific new product. However, even if additive inventions are cost-effective, they may not always be affordable within the NHS budget. Other innovations are ‘substitutive’ – where they replace and remove existing services, and are proven to be genuinely cost-saving or cost-neutral in real world trials as opposed to theoretical models. When NHS budgets are constrained, it is much easier to spread substitutive, rather than additive, innovations. One way of further aligning NHS and industry interests is for all partners to focus more on innovations that both improve outcomes and at the same time reduce cost.

SCIENCE AND INNOVATION

1. How can investors be encouraged to invest in turning basic life science research into new innovations in treatment? Why has investment been lacking in this sector? Does the research base have the necessary infrastructure to be world-leading?

2. Why has the UK underperformed in turning basic research in the life sciences into intellectual property? What needs to be done to address this historic weakness in the UK and grow new companies to commercialise new research and related technologies in the life sciences?

3. What can be done to ensure the UK has the necessary skills and manpower to build a world class life sciences sector, both within the research base and the NHS?

The health of the innovation pipeline depends on the health of each of its component parts, and how well each piece is connected together: from basic scientific discovery through to widespread adoption and spread in this country and internationally.

Since 2013, NHS England has funded a national network of 15 Academic Health Science Networks (AHSNs) to act as a bridge between academia, industry and the NHS, supporting researchers and innovators to deliver change in the NHS. They are the NHS distribution network for innovation, and they work closely with our leading research centres, including the designated Academic Health Science Centres.

The AHSNs are all now adopting the same approach to supporting the innovation pipeline. This includes directly supporting industry colleagues and helping them navigate through the NHS, for example by connecting them to specific local clinicians, to develop test and refine their products.

Over the last four years, the AHSNs estimate that they have supported spread of over 200 innovations across the NHS; leveraged £330 million to improve health and support NHS, care and industry partners; supported contract awards to over 450 SMEs; and helped create over 500 new jobs[2]. They have undoubtedly made a notable difference, with scope to do a lot more.

NHS England’s Board agreed in July 2017 to back AHSNs with a further 5 year licence, subject to approval of collective and individual value propositions. In September 2017, the AHSNs established eight Innovation National Networks, aimed at strengthening their ability to work as one – to identify, adopt and spread the very best innovations across the country, and develop common metrics and methods. In October 2017, AHSN Chief Officers will discuss initial proposals with NHS England’s board, prior to submitting their plans for relicensing at the turn of the year.

We are also:

-          working to articulate our research needs as clearly as possible, including through our research strategy (described later in this submission), working alongside the National Institute for Health Research (NIHR). NHS England will be taking an update to a public Board meeting later this year;

-          running the NHS Small Business Research Initiative (SBRI) Healthcare Programme. Since 2013/14, NHS England has committed £75.1m to this programme, which supports early stage development of products to meet NHS needs. In order to tap into frontline issues within the NHS, it works intensively with patient, clinical and commissioning leads to understand where there are opportunities for technology interventions, and devises competitions for industry based on this intelligence, and helps companies to access procurement opportunities. Under NHS England sponsorship, SBRI Healthcare has initiated over 150 projects and in 2016/17 held competitions for products to improve patient flow in the acute sector, self-care and independence for children with long-term conditions and general practice. SBRI Healthcare is estimated to have created or safeguarded over 700 jobs, attracted £140m in external investment and supported 135 new intellectual property applications[3];

-          offering NHS clinicians the support and education they need to develop and commercialise their ideas, through our Clinical Entrepreneur Programme. In its first year, following launch in November 2015, clinicians supported by the programme created 50 start ups and over 300 jobs, generated 136 partnerships and collaborations and raised more than £48m of addition private sector funding. In 2017, we are expanding our recruitment beyond doctors to include healthcare scientists and dentists;

-          investing in individuals who have innovative ideas. By providing bespoke support to innovators, we are getting their products, services and technologies into the NHS more quickly through the NHS Innovation Accelerator (NIA). The NIA is supported by all the AHSNs and since 2015/16 has supported 25 individuals to spread their innovations into over 700 NHS organisations. To date, innovators supported by the programme have created over 50 jobs and secured an additional £31m in funding[4]. A third cohort of innovators will be announced in late 2017/18;

-          investing in new approaches to evaluation. For example, working with over 50 innovations, from 40 different innovators across seven different sites, our Test Beds programme is testing new combinations of innovations in ‘real-world’ settings. Through joint investment from the Department of Health and NHS England of £9.5m[5], we have leveraged around £15m investment from industry to test whether new approaches can deliver better outcomes than current services for the same or less cost. The Test Beds are already demonstrating the kind of collaboration between the NHS and industry proposed in the Life Science Industrial Strategy, and at Expo we announced our extension of funding for a further two years;

-          supporting market opportunities internationally, through our sponsorship of Healthcare UK. Jointly funded by NHS England, the Department of Health and the Department of International Trade (DIT), Healthcare UK acts as an intermediary between overseas bodies (e.g. governments and healthcare providers) that are interested in procuring the services of UK healthcare organisations. Both NHS and non NHS organisations can access support from Healthcare UK to develop their ability to engage in commercial business internationally. Healthcare UK has helped health sector organisations win over £5 billion[6] worth of contracts over the last three years.

Sir John Bell’s report highlights a number of opportunities. NHS England has already signalled its intention to back a number of these, such as on data hubs and artificial intelligence, including through Simon Stevens’ speech at the NHS Innovation Expo in Manchester. We sponsor and host Expo, which brings together NHS and business partners and over 5000 delegates, exploring the latest innovations and developments in health and social care.

INDUSTRIAL STRATEGY

4. How does the UK compare to other countries in this sector, for example Germany and the United States?

5. What can be learnt from the impact of the 2011 UK Life Sciences Strategy? What evidence is there that a strategy will work for the life sciences sector? How can its success be measured against its stated objectives?

Our view is that significant progress was catalysed by the publication of Innovation, Health and Wealth.

For example, we now have a functional innovation distribution network across the NHS through the AHSNs. Take the digital tool, myCOPD. This was initially supported by Wessex AHSN. It secured support from the National Innovation Accelerator, and NHS England then funded it as part of the new Innovation and Technology Tariff. The AHSNs are now supporting widespread adoption. The number of NHS licenses issued has risen dramatically to over 45,000 in September 2017. This could not have happened five years ago.

6. Does the strategy contain the right recommendations? What should it contain/what is missing? How will the life sciences strategy interact with the wider industrial strategy, including regional and devolved administration strategies? How will the strategies be coordinated so that they don’t operate in ‘silos’?

We have already signalled our support for a number of Sir John Bell’s recommendations. NHS England is working closely with Government and partners in developing the ‘sector deal’. We wish to make rapid progress in priority areas that support NHS transformation; support economic growth; strengthen place-based plans; and at the same time are affordable for the NHS.

Coordination and join-up with wider strategies – including the NHS’ own strategy - is vitally important. At the same time, NHS England suggests that success or failure of the agreed actions will depend primarily on the quality of implementation.

7. What opportunities for small and medium sized enterprises (SMEs) are there/should there be in the strategy? How can they be involved in its development and implementation?

We have highlighted the role of AHSNs in supporting SMEs and their hosting of the SBRI. Sir John’s report sets out a range of further potential opportunities, for example in digital and artificial intelligence.

8. Where should the funding come from to support the implementation of the strategy?

Life sciences research and innovative product development is primarily funded by industry, the NIHR, the research councils, the NHS, the voluntary sector and universities – backed by the Government.

NHS England currently funds a range of initiatives from within our core funding. We are constrained by what is affordable, as well as the wider array of objectives set out in the Government’s Mandate to NHS England[7]. The NHS financial settlement for the NHS in 2018/19 is particularly challenging. NHS England is therefore looking to the life sciences strategy to assist in reducing rather than increasing NHS costs.

9. How do the devolved administrations and city regions fit into the strategy? Scotland has its own life sciences strategy, how will the two interact?

NHS England works with the NHS in Scotland, Wales and Northern Ireland on areas of common interest and benefit. We are active in supporting devolution - for example, in Greater Manchester and Surrey – and unlocking the synergies between innovation, health and wealth.

NHS PROCUREMENT AND COLLABORATION

10. How can public procurement, in particular by the NHS, be an effective stimulus for innovation in the Life Sciences Sector? Can it help support emerging businesses in the Life Sciences sector?

As recommended by the Accelerated Access Review (AAR), NHS England is establishing a new commercial unit with the capacity and capability to consider a range of flexible pricing models as part of a commercial dialogue with innovators. Our ambition is to create win-win scenarios, where innovators benefit from earlier and, in some cases, guaranteed market access and the NHS and patients benefit from better value through reduced prices.

We are also using a number of financial levers to incentivise innovation and adoption. For example, the Innovation and Technology Tariff (ITT) has enabled med-tech devices and apps to be included under NHS national payment rules helping to accelerate uptake. We launched the ITT in April 2017, agreeing discounted national prices with suppliers and ‘bulk buying’ proven technologies at a national level, removing the need for multiple local price negotiations. Since the launch of the ITT, over 45,000 patients are benefitting from being able to self-manage their severe or very severe COPD symptoms; 460 pairs of reusable angled Episiotomy scissors have been bought by maternity trusts in England, reducing the likelihood of OASIs injuries to women in labour; nearly 1,000 ventilation tubes that reduce the incidence of Ventilator Associated Pneumonia are in use in hospitals; and nearly 3,000 devices that prevent injection of fluids into an artery are being used, all keeping patients safer.

To extend the scope of the ITT, we announced the Innovation and Technology Payment (ITP) in June 2017. The ITP supports a wider range of medical devices, digital platforms and technologies and unlike the ITT is not limited to secondary care. It focuses on low cost innovations which can deliver great quality and efficiency benefits. An initial call for applications closed in early September and received 270 responses. These applications are currently going through a screening and review process ahead of a final selection panel in December. Our aim is to go live with ITP in April 2018.

As noted earlier, however, affordability remains a constraining factor in our ability to fund and adopt new technologies. From April 2017, in partnership with NICE we introduced a budget impact test. This assesses the financial impact of a technology over the first three years of its use in the NHS. If the budgetary impact exceeds £20million in any of these years NHS England may engage in commercial discussions with the company to mitigate the impact that funding the technology would have on the rest of the NHS[8].

The life sciences sector will always want the NHS to be able to afford to fund ‘additive innovations’. NHS England is also particularly interested in ‘substitutive innovations’ that simplify pathways and take out cost. However, the benefits of these only accrue when local NHS systems do the redesign, integrate the innovations, and genuinely take out cost. These are unlikely to be achieved through simple national procurement.

11. How can the recommendations of the Accelerated Access Review be taken forward alongside the strategy? Will the recent changes to the NHS England approval process for drugs have a positive or negative effect on the availability of new and innovative treatments in the NHS? How can quick access to new treatments and the need to provide value for money be reconciled?

In September 2017, NHS England has commissioned the AHSNs to identify cost-effective, high-impact ‘designated innovations’ that the AHSNs consider should be rolled out on a nationwide basis, and where they will commit to achieving this spread as a collective of fifteen. These are likely to be in the areas of medtech, digital and pathway redesign.

For technologies that offer exceptional value for money, NICE and NHS England introduced a fast-track appraisal on 1 April 2017. This offers both a shorter appraisal process, and a shorter period for introducing new technologies. Appraisal will take place through a tailored process, defined by the relationship between cost-effectiveness and likely quality adjusted life years (QALYs) gained. If a positive recommendation is made through that process, NHS commissioners have committed to providing funding for the technologies within 30 days of guidance publication. These changes will benefit patients by providing quicker access to the most effective and cost-effective new treatments[9].

Within the specific area of specialised services our work continues to deliver cutting-edge care and innovation in a number of clinical areas, supporting pioneering clinical practice. For example, we are rolling out new oral treatments for Hepatitis C, with approximately 20,000 patients treated by August 2017 reducing mortality by around 10% and liver transplants for these patients by around 50%. By 2019, more than 6,200 brain tumour patients a year will benefit from the use of stereotactic radiosurgery and radiotherapy, up from 2,400 in 2014/15; as a result, fewer people are undergoing more invasive and costly treatments. Over 100 radiotherapy linear accelerators will be upgraded or replaced over the next two years; around 45 children aged 2-5 with cystic fibrosis will benefit from ivacaftor, a precision medicine available on the NHS thanks to a deal struck with the manufacturer to reduce the price; mechanical thrombectomy treatment for stroke will be rolled out, to ultimately benefit up to 8,000 stroke patients a year once fully implemented; and up to £8m will be made available over five years to fund the treatment costs of a world-leading evaluation of mitochondrial donation, a form of IVF in which the future baby’s mitochondrial DNA comes from a donor egg, to avoid passing on inherited mitochondrial diseases[10].

The Cancer Drugs Fund (CDF) which began in 2010 has benefitted over 15,000 patients providing 55 different cancer treatments up to six months earlier than they otherwise would have done. The CDF was significantly recast in July 2016 to put it onto a more sustainable financial footing and to create a funding stream for progressing new cancer treatments where the evidence of real world benefit was uncertain at the time of marketing authorisation/initiated NICE appraisal. Subsequently, 17 drug indications previously funded via the CDF have now been approved for routine commissioning following positive NICE appraisals around their clinical and cost effectiveness. An additional 17 new drug indications (never previously funded by the CDF) have also benefitted from our new interim funding arrangements. So far, this has meant at least 2,300 patients being approved to start treatment many months earlier than under the old arrangements. New Managed Access Agreements have already been put in place for 5 drug indications, benefitting 740 patients so far and counting. We anticipate at least 6 more of these agreements to be in place by the end of March 2018.

Finally, as more biological medicines lose patent exclusivity, we are supporting early access to biosimilar medicines offering safe, effective treatment for patients and cost savings for the NHS. NHS England has set the aim that 90% of new patients will get the best value biological medicine within three months of the launch of a biosimilar, and 80% of existing patients where it is clinically appropriate will make that transition within 12 months. This could save up to £300 million over the next several years. For example, switching to biosimilar Infliximab (now used by 80 per cent of patients with rheumatology conditions and inflammatory bowel disease) and biosimilar Etanercept (used by nearly 60 per cent of patients with rheumatology conditions) has already saved the NHS approximately £160 million per annum. In 2018, biosimilar Adalimumab will become available, which is used to treat rheumatology conditions and inflammatory bowel disease – this will offer a biosimilar alternative to the current medicine which accounts for the highest spend in hospitals – more than £300 million in 2015/16.

12. How can collaboration between researchers and the NHS be improved, particularly in light of increased fiscal pressures in the NHS? Will the NHS England research plan help in this regard? How can the ability of the NHS to contribute to the development of and adopting new technology be improved?

NHS England is putting a strengthened focus on research, innovation and life sciences with the establishment of the Life Sciences and Innovation Group, within the Strategy and Innovation Directorate.

NHS England’s research plan describes how we drive the direction of research, help create an environment that fosters research and support the use of evidence in decision making. This is the first step in setting out our wider strategic approach to research.

One way in which we are working to improve support to researchers is by simplifying payment of Excess Treatment Costs (ETCs). These apply when treatment costs associated with research interventions cost more than care does under normal circumstances. These costs should be met by routine commissioning but there are times when this does not happen, causing friction between provider and commissioner. NHS England in collaboration with the Department of Health and Public Health England is working to simplify the mechanisms for agreement and payment of ETCs. An options appraisal is being developed for joint assessment by NHSE and the Department of Health during early October.

Work on ETCs forms one facet of many on research, and we are working closely with the NIHR to progress a range of actions including on identifying research needs better, getting the linkages right between Clinical Research Networks, NIHR Collaborations for Leadership in Applied Health and Research and AHSNs, and data hubs.

We are also examining how the commissioning of NIHR research programmes can be better tailored to current demands. We are working with the Department of Health and the NIHR to strengthen our process for identifying research needs. This autumn, NHS England will host six research needs seminars to cover key priority areas (Urgent & Emergency Care, Mental Health, Primary Care, Cancer, Diabetes and Specialised Commissioning) which bring together clinical and policy experts to identify potential gaps in the NIHR pipeline and prioritise future needs to feed into the NIHR and UKRI processes.

One of the main ways in which the innovation pipeline can be enhanced is to ensure that innovations are evaluated including for their economic and real-world NHS financial impact. NHS England is keen to see enhanced research capacity in this area.

Research will yield even greater benefit if we can improve our use of NHS datasets. We are seeking to better exploit the comparative advantage that the NHS has with the breadth of anonymised data at our disposal. By the end of 2017, we will set out a joint process with NHS Digital to identify three to five locations across the country that will go live with digital innovation hubs. This ‘target architecture’ will enable the use of data for clinical and other research as part of consented trials and will adhere to national standards and governance processes. We will also be making the case for public investment and directing NHS England investment into artificial intelligence and machine learning, exploring how automated interrogation of radiology and pathology datasets can improve the quality and efficiency of clinical care. In addition, alongside the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA), we are helping an additional 1800-2000 General Practices (GPs) allow their data to be used by the Clinical Practice Research Datalink (CPRD) by March 2018.

Our 100,000 Genomes Project (working in partnership with Genomics England) is at the forefront of new ways to harness and utilise clinical data for research and is due to complete in 2018. We have invested £30m to establish 13 Genomic Medicine Centres and by March 2017 these centres had processed a total of 28,205 DNA samples covering rare diseases and cancer against an overall target of 60,000 samples. As a result more patients who are eligible for clinical trials have been identified and recruitment to NIHR portfolio studies has increased. We are also working with clinical interpretation partners to maximise the information obtained from whole genome sequencing and Genomics England has been working with 14 commercial companies in the pre-competitive GENE consortium.

Given the unique environment for research and innovation the NHS provides, we are examining how we can maximise and exploit intellectual property, developed in partnership with the NHS. Learning from the 100,000 Genomes Project is helping inform how we work with the HRA to create a more fertile environment for clinical trials by harmonising approval and recruitment processes. We are also working with our innovation partners in OLS and the Department of Health to map and streamline routes to evaluation and market for innovative drugs, devices and other products. This work is being undertaken internally but progress will be described at a public board meeting out later this year.

RESPONSIBILITY AND ACCOUNTABILITY

13. Who should take responsibility for the implementation of the Life Sciences Industrial Strategy and to whom should they be accountable? What should the UK Government’s role be? What should the role of the academic, charitable and business sectors be?

14. What is the role of companies within the sector, particularly the large pharmaceutical companies, in the implementation of the strategy? How are they accountable for its success?

15. Does the Government have the right structures in place to support the life science sector? Is the Office of Life Sciences effective? Should the Government appoint a dedicated Life Sciences Minister? If so, should that Minister have UK-wide or England-only responsibilities?

At a national level, NHS England works closely with the Department of Health and Department of Business, Energy and Industrial Strategy. It is further strengthening its focus on life sciences through establishing a Director-level group responsible for driving Life Sciences and NHS Innovation, as well as its work on information, specialised commissioning, and commercial procurement through the work of the new commercial unit.

Implementation will come from a partnership between Government, the NHS, industry, and the universities.

Accountability for making decisions that affect NHS budgets has to lie with those NHS organisations accountable to Parliament for the NHS budget. Next Steps on the NHS Five Year Forward View[11] highlighted how the NHS has to make difficult prioritisation decisions.

The success of the strategy also depends on local implementation. First adoption and wider spread of innovation are the products of engaging with local NHS systems. For example, accountability for spreading the product themes in the innovation and technology tariff lies with the 15 Academic Health Science Networks, who are accountable to NHS England through their license. Through their boards and local partnership arrangements, AHSNs are also accountable to their own local systems.

BREXIT

16. What impact will Brexit have on the Life Sciences sector? Will the strategy help the sector to mitigate the risks and take advantage of the opportunities of Brexit?

17. How should the regulatory framework be changed or improved after Brexit to support the sector?

18. To what extent should the UK remain involved with and contribute to agencies such as the EMA post Brexit?

On Brexit-related issues, NHS England works closely with the Department of Health to identify and mitigate risks, and consider possible opportunities. We have a dedicated NHS Brexit Unit. Workstreams with the Department of Health include research, medicines and medtech, workforce, and ensuring continuity of the NHS supply chain.

28 September 2017