Innovation and accelerated access to healthcare
(i) Overcoming any barriers to developing, commercialising and adopting medical
technologies in the NHS.
(ii) Speeding up access to drugs, devices, diagnostics and digital health products that
can help change the lives of NHS patients, including the work of The Accelerated
Access Review.
1.
DIAGNOSIS:
 For the primary policy aim in this area, what the Government knows about the
issue, its causes, effects, and scale; and the extent to which the Government
identifies this area as a priority for action.
 How the Government has assessed the strengths and weaknesses of that
evidence.
The issues considered in this paper on Innovation and Accelerated Access to
Medicines are priorities for the government:
1. Overcoming any barriers to developing, commercialising and adopting medical
technologies in the NHS and
2. Speeding up access to drugs, devices, diagnostics and digital health products,
that can help change the lives of NHS patients, including the work of The
Accelerated Access Review.
The Department of Health is both gathering more evidence through the Accelerated
Access Review and in parallel, working with partners on specific interventions to
promote the identification and adoption of innovation.
The Government’s policy aims for innovation are: “overcoming barriers and creating
incentives for the promotion of health care innovation – translation of discovery into
real benefits for patients, and addressing barriers to early adoption and diffusion of
innovation in the NHS”1. What’s good for patients will also be good for growth making this country a world leading place to design, develop and deploy medical
innovations will stimulate investment and create a stronger NHS.
The need for innovation and the issues surrounding it within our healthcare system
have been explored in a number ways, including: Innovation, Health and Wealth2,
research for the Accelerated Access Review3,4and evidence collected through ongoing work such as the Innovation Scorecard and Test Beds.
1
Department for Business Innovation and Skills (2011) Strategy for UK Life Sciences. Accessed:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/32457/11-1429-strategy-for-uk-life-sciences.pdf
2 Department of Health (2011) Innovation Health and Wealth, Accelerating Access and Diffusion within the NHS. Accessed:
http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/document
s/digitalasset/dh_134597.pdf
3 Wooding, S et al (2015) Insights into Early Adoption on medical innovations. Accessed:
https://www.gov.uk/government/publications/improving-access-to-medical-technologies-an-international-review
4 Monitor Deloitte (2015) Accelerated Access Review: UK Mapping. Accessed:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/444246/AAR_UK_Mapping.pdf
Looking specifically at innovating in medical technologies, which include a wide
range of healthcare products used to diagnose, monitor or treat diseases or medical
conditions, the UK is particularly slow, relative to other developed economies, in
adopting innovative medical technologies:
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Currently, it can take 12 years to research and develop a new medicine. This
process can cost over £1 billion with uptake of innovative products by the
NHS perceived to be slow5.
In 2012/13 the UK’s overall ranking across all of the medicines studied for
usage per person was 9th highest of 13 high income countries6. (NOTE: This
ranking should be treated cautiously though as the analysis does not take into
account the prices of drugs in different countries, different healthcare systems
and pathways and whether it was financially sustainable to be ranked number
1).
For devices, whilst the development time is more difficult to calculate, uptake
is also perceived to be slow due to a number of barriers: work for the
Accelerated Access Review in particular identified a lack of consistent route to
market, a disconnect between what the system wants and the development of
new products, and the process re-engineering often required to support
implementation.
The Innovation, Health and Wealth (IHW) report7 makes the case that innovation can
improve both quality and productivity and that, in the context of increasing demands
for care in a financially constrained system, innovation can help improve efficiency
and thus the sustainability of the NHS. We need to harness the best of our clinical,
research, academic and industry expertise to meet and address these challenges.
For these reasons, innovation in healthcare is a priority action for Government and
the Government is committed to transforming the health system to respond to the
challenges. There is a cross government approach to our response. The Minister for
Life Sciences, George Freeman MP, has been charged by the Prime Minister and
the Secretary of State both in the Department of Health (DH) and the Department for
Business, Innovation and Skills (BIS) with driving forward progress against the
Government’s various manifesto commitments relating to Health and Life Sciences,
and to ensure that the UK remains a powerhouse in Life Sciences in the 21 st Century
as we were in the 20th. In addition, in April 2014 DH and BIS developed a joint life
sciences function to create a joint and bigger Office for Life Sciences.
The Government has assessed the evidence on innovation and accelerated access
to medicines, medtech, diagnostics and digital though a number of ways including:
5
APBI (2014) Delivering Value to the UK: the contribution of the pharmaceutical industry to patients, the NHS and the economy. Accessed
on: http://www.abpi.org.uk/our-work/library/Documents/delivering_values_dec2014.pdf
6 ABPI / Office of Health Economics (2014) International comparisons of medicines usage: quantitative analysis. Accessed on:
http://www.abpi.org.uk/our-work/library/industry/Documents/meds_usage.pdf
7
Department of Health (2011) Innovation Health and Wealth, Accelerating Access and Diffusion within the NHS. Accessed:
http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/document
s/digitalasset/dh_134597.pdf
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A call for evidence8, which informed IHW and included the barriers to
innovation.
Ongoing reviews of current interventions. For example, a review of EAMS,
which will also feed into the Accelerated Access Review and is currently
being undertaken and due to report at the end of November.
Regular analysis of the Innovation Scorecard data on uptake of medical
technology in the NHS9 by NHS England.
Whilst there is some evidence on both the barriers to innovation and what we need
to do to speed up access, it is patchy and does not consider a “whole system”
approach to the health system pipeline. We recognise that we need more evidence
to inform the future approach and for this reason, the DH has set up the
independently chaired Accelerated Access Review (AAR). The next section outlines
our action plan for gathering further evidence in more detail, as well as some specific
interventions we are currently implementing to promote the identification and
adoption of innovation.
2.
ACTION/PLANS:
 If the Government has chosen an intervention in this area, why it has selected
that one.
 What evidence, if any, that that choice of particular intervention is based on.
 How the Government has assessed the strengths and weaknesses of the
evidence base underpinning potential interventions, including what has been tried
before and whether that worked or not.
 Whether there are other options to meet the primary policy aim in this area,
including different approaches in different devolved administrations, and why they
have not been chosen in this case.
 What the Government plans to do about any part of the intervention that has not
yet been decided.
The Government has chosen a package of interventions to reduce barriers to
innovation and improve access, because there is no single strategy or approach
alone that delivers innovation. IHW proposes a variety of approaches and to monitor
and evaluate these, and ensure that learning is fed back into future actions.
There are a cluster of measures designed to support the uptake of innovation in the
NHS (the refocusing of Academic Health Science Networks, a new approach to the
Small Business Research Initiative, the use of system levers and incentives to drive
innovation uptake) which could also significantly boost the uptake of genuinely costand clinically-effective innovation in the NHS if pursued as a package. Details of
these measures already being carried out are included here:
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8
Academic Health Science Networks –One of the key reasons for the slow
spread of innovation identified in the IHW was the “lack of effective and
systematic innovation architecture”. Academic Health Science Networks
(AHSNs) have been set up to support local health economies to improve health
NHS Chief Executive’s Review of Innovation in the NHS Summary of the responses to the Call for Evidence and Ideas (2011)
http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@e
n/documents/digitalasset/dh_131570.pdf
9
NHS England, Innovation Scorecard. Accessed: https://www.england.nhs.uk/ourwork/innovation/innovation-scorecard/
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10
outcomes in their communities, and maximise the NHS’s contribution to
economic growth by enabling change through collaboration, and the spread of
innovation and best practice. To do this, they bring together local NHS partners,
academia and industry by acting as catalysts, brokers, coordinators, sponsors
and knowledge-sharers.
There are 15 ASHNs across the country. Speeding up adoption of innovation into
practice to improve clinical outcomes and patient experience has been one of the
four core contractual objectives for AHSNs since their establishment in 2013. As
well as directly supporting partners to diffuse specific innovations and best
practice, AHSNs also work to create an infrastructure and environment that
enables the development, identification and adoption of innovation. This work
encompasses the establishment of partnerships and networking opportunities, as
well as investment in infrastructure.
AHSNs are supporting over 150 active programmes and projects across a range
of clinical and cross-cutting themes. These have been selected in response to the
priorities of their local populations and health economies. In addition to their
individual programmes, AHSNs also work collectively to support national priorities
which include a Medicine’s Optimisation programme. AHSNs have taken a range
of approaches in delivering their objectives. Case studies and exemplars of some
their work can be found in the resources section of the AHSNs Network website:
www.ahsnnetwork.com.
Small Business Research Initiative (SBRI) Plus –SBRI Healthcare and SBRI
DH are the two healthcare focused SBRI schemes seeking to find innovative
solutions to unmet need within the NHS; thus meeting the commercialisation
challenge in the NHS. They set focused challenge calls to which innovators can
submit their responses. These are then assessed on their merit, considering
route to market and viability.
100,000 genome project – The 100,000 Genomes Project was launched in
December 2012 as part of the government’s ‘Strategy for UK Life Sciences: one
year on” report10. The Human Genomics Strategy Group produced a report in
201211, which followed on from the House of Lords Science and Technology
Committee Inquiry into Genomic Medicine, which was drafted in consultation with
varied stakeholders12. On the basis of this it became a Prime Minister’s priority.
The project will deliver one of the largest datasets in the world linking genomic
and medical (phenotypic) data. Leading scientific researchers will analyse the
dataset and interpret the findings to identify new scientific and medical
breakthroughs. On 11th March 2015, it was announced that the first patients had
been diagnosed with rare diseases through the 100,000 Genomes Project.
Early Access to Medicines Scheme (EAMS) - An Expert Group on innovation
in the regulation of healthcare was established in June 2012 following the Prime
Minister’s 2011 Life Sciences Strategy. Their report to DH and BIS Ministers
fulfilled the commitment in the strategy for a task and finish group to conclude
and report to ministers in September 2013 on regulatory innovation, which
endorsed the Development of the Early Access to Medicines Scheme (EAMS).
Department of health (2012) Strategy for UK Life Sciences: one year on. Access:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/36684/12-1346-strategy-for-uk-life-sciences-one-yearon.pdf
11 Human Genomics Strategy Group (2012) Building on our inheritance: Genomics Technology in Health. Accessed:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213705/dh_132382.pdf
12
Science and Technology Committee (2008-9) Genomics Medicine v1: Report. Accessed:
http://www.publications.parliament.uk/pa/ld200809/ldselect/ldsctech/107/107i.pdf
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EAMS demonstrates a commitment from the UK to pharmaceutical innovation,
providing a platform for drugs to be brought to patients at a much faster rate than
ever before. The purpose is to support access in the UK to unlicensed or offlabel medicines representing a significant advance in treatment in areas of unmet
medical need and in this way acted as a trailblazer for the Accelerated Access
Review. There have been 8 Promising Innovative Medicine (PIM) designations
and 4 Scientific Opinions awarded by the MHRA since the launch of the scheme
in April 2014.
National Institute for Health Research (NIHR) – The NIHR is the most
integrated health research system in the world which supports outstanding
individuals working in world-class facilities in the NHS, conducting leading-edge
research focused on the needs of patients. The NIHR’s vision is to improve the
health and wealth of the nation through research. NIHR supports the
development and translation of drugs, devices, diagnostics and digital health
products that help change the lives of NHS patients, and improve the health of
the population. It does this by a full range of targeted research funding including
by:
o funding world-class research infrastructure in the NHS that pulls
discoveries from the country’s excellent basic and discovery science
into excellent translational research and benefits for patients;
o supporting and enabling public, charity and life sciences research in
the NHS though the NIHR Clinical Research Network which enabled
99% of NHS Trusts in England to participate in high quality clinical
research in 2014/15;
o by providing research funding though a wide range of research
programmes (including the NIHR Health Technology Assessment,
Invention for Innovation, Efficacy and Mechanism Evaluation, Health
Innovation Challenge Fund (a partnership between the Department of
Health and the Wellcome Trust, and Health Service and Delivery
Research) and Health Services and Delivery Research to evaluate the
effectiveness and impact of new healthcare treatments, find new ways
of preventing, identifying and treating ill health, and making this
evidence widely available to ensure that decisions about health and
social care are being informed by the best possible evidence; and
o funding 13 NIHR Collaborations for Leadership in Applied Health
Research and Care which each bring together a collaboration of the
local providers of NHS services and NHS commissioners, universities,
other relevant local organisations and the relevant Academic Health
Science Network. CLAHRCs conduct applied health research across
the NHS, and translate research findings into improved outcomes for
patients.
The Government has assessed the effectiveness of these specific interventions in a
number of ways including a call for evidence13, which informed IHW and included the
barriers to innovation, an update of IHW14 and an update on the progress for
13
Department of Health (2011) NHS Chief Executive’s Review of Innovation in the NHS Summary of
the responses to the Call for Evidence and Ideas. Accessed:
http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@e
n/documents/digitalasset/dh_131570.pdf
14 Department of Health (2012) Creating Change: Innovation, health and Wealth one year on. Accessed:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213204/Creating-Change-IHW-One-Year-On-FINAL.pdf
implementing measures in the Strategy for UK Life Sciences15 - these updates have
fed into policy development. There are also a number of policy evaluations planned,
which will be published, such as an IHW evaluation, to ensure we learn from these
policy interventions.
We need to develop and implement options that fit the NHS model of care and policy
is constantly evolving to keep up with innovation and changing patient expectations.
Other options for meeting our primary policy aim, reducing the barriers to innovation
and accelerating access to health care, are therefore being reviewed alongside the
evidence base and constantly informed through comparisons with other countries
and other sectors in England.
We recognise there is more that we need to do, and this will remain a focus for this
Government. The process for innovation is not constant and reflects the changing
health needs and health system that we live in. Therefore by its nature, the
innovation process and interventions are constantly evolving and there are gaps in
our evidence base and therefore our knowledge to inform future policies.
To generate more evidence, the DH asked Sir Hugh Taylor to independently chair
the Accelerated Access Review (AAR). The aim of the AAR is to improve access to
innovative medicines and medical technology in the NHS and revolutionise the
speed at which 21st century innovations in medicines, medical technologies and
digital products get to NHS patients and their families. By capitalising on advances
in genomics, data, digital health and informatics, the AAR aims to address these
challenges and accelerate access to cost-effective new products.
Extensive work has been carried out, in the AAR, articulating the need, priorities and
principles for innovation. The work focuses on describing the end-to-end ‘pathways’
for pharma, medtech, in vitro diagnostics and digital by which innovative medical
technologies pass from conception to widespread patient access, identifying key
barriers to rapid NHS adoption of such innovations, challenges to industry and
opportunities to improve patient access. The overarching aim of this work is to
improve patients’ health outcomes through faster access to efficacious medical
innovations (including drugs, devices and digital products), not to expand the market
for manufacturers of innovations per se or to promote innovation for its own sake.
Particular opportunities are seen here for both patient benefit and cost savings
through the more systematic uptake of medical devices and digital health products.
The AAR’s interim report outlines a number of key propositions to improve and
accelerate access to innovative products (drugs, devices and digital health) for
further exploration with stakeholders16. The final report is due in April 2016. The
Government made a commitment to implement the findings of the AAR.
In parallel to the AAR, the Department of Health and its partners are gathering
further evidence about specific parts of the pathway to help us to understand and
15
Department of health (2012) Strategy for UK Life Sciences: one year on. Accessed:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/36684/12-1346-strategy-for-uk-life-sciences-one-yearon.pdf
16
Accelerated Access Review, Department for Business Innovation and Skills, Department of Health (2015) Accelerated Access Review:
Interim Report. Accessed: https://www.gov.uk/government/publications/accelerated-access-review-interim-report
create the right environment for innovation that can be later duplicated. One of our
key partners is NHS England. In their Five Year Forward View17, a number of key
initiatives were set out which aim to improve the adoption of innovation in the NHS.
We are working closely with NHS England to support the delivery of these initiatives.
These evidence gathering interventions include:
 The innovation scorecard (Latest publication: 1st October 2015
http://www.hscic.gov.uk/catalogue/PUB18515 ). The objective of the Innovation
Scorecard is to support appropriate access to NICE approved products
(medicines, devices and diagnostics), by giving Health and Care commissioners
and professionals’ information they can use to identify and act on unwarranted
variation in patient access to these treatments. The aim is therefore to reduce
variation in the NHS, and drive greater compliance with NICE guidance – by
using transparency to drive up performance.
 Test Beds – NHS England with the Department of Health is developing a number
of ‘test bed’ sites in partnership with AHSNs and Academic Health Science
Centres. Test Beds will partner global innovators with NHS organisations to trial
combinations of new technologies with innovations in how NHS services are
delivered at scale and in a real clinical setting. The Programme is an opportunity
for the needs of the health and care system and the creative energy of industry to
come together to speed up the implementation of digital technologies for patient
benefit and to promote economic growth. The Test Bed programme was
launched in March 2015 and development of partnerships have been supported
with the aim of designating test beds in December 2015.
 Sector Councils – the Office for Life Sciences, jointly with the lead industry trade
bodies (British Pharma Group and Association of British Healthcare Industries)
convenes two Life Science Sector Councils; one focused on medicines, the
Ministerial (Bio-pharmaceutical) Industry Strategy Group (MISG –
https://www.gov.uk/government/groups/ministerial-industry-strategy-group) and
the other on medical devices and diagnostics, the Ministerial Medical Technology
Strategy Group (MMTSG - https://www.gov.uk/government/groups/ministerialmedical-technology-strategy-group). These meet twice a year to maintain a
strategic dialogue between policy officials and senior executives from the relevant
industry sectors. This helps ensure key issues concerning the development of
these industry sectors, their products and their interaction with the health system,
including factors concerning the development of latest medicines and medical
devices and their timely availability to patients, are presented directly to Ministers
and their officials.
 Lord Carter’s Review – Lord Carter was asked by the Secretary of State for
Health to look at what could be done to help NHS trusts deliver improvements in
their operational productivity. As part of this work, Lord Carter worked with 22
NHS trusts to develop a metric for measuring operational efficiency – the
Adjusted Treatment Cost (ATC). His interim report was published in June this
year18. The interim report estimated that up to £5bn could be saved if trusts
secured a tighter grip of their resources, most importantly workforce which
accounted for two thirds of the cost. He stated that further savings were possible
by addressing workflow in, out and within hospitals. Lord Carter recommended
17
18
NHS England (2014) Five Year Forward View. Accessed: https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdfm
Lord Carter of Coles (2015) Review of Operational Productivity in NHS Services, Interim Report. Accessed:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/434202/carter-interim-report.pdf

that NHS trusts need to adopt a common set of metrics to monitor and improve
productivity and efficiency. He also concluded that a model NHS hospital to
demonstrate what good look likes like would help trusts improve their operational
productivity. His final report is expected in December. The Department of Health
is now exploring ways in which this work could act as a “pull” for innovation that
helps to improve productivity and efficiency in Trusts.
Developing industry – genomics and digital health - As well as innovation in
traditional areas of healthcare, there are currently some disruptive technologies /
sectors out there which the NHS needs to harness – for example, genomics and
digital health – and we are therefore focusing on how we might support these
industries in the UK. We have been gathering evidence on the makeup, size, of
the genomics and digital health industry in the UK and the potential barriers and
opportunities to growth. This evidence has been made public19,20. These are
high growth areas and our view is that such high growth potential warrants
support from Government to help the sectors deal with the challenges and
opportunities
3.
IMPLEMENTATION:
 For the primary policy aim in this area, how will the chosen intervention be rolled
out?
 If an intervention has been made or is planned, why that method for delivering
the intervention has been chosen.
 What evidence, if any, that decision is based on.
 Whether there are other implementation methods and, if so, the reasons for not
choosing them.
A number of interventions have been rolled out including the ASHNs, SBRI, EAMS,
100,000 Genome project, NICE Implementation Collaborative, the Innovation
scorecard, the National Institute for Health Research and the web portal.
The AAR is considering the evidence and the Government has committed to
implementing the AAR’s findings in its manifesto.
4.
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VALUE FOR MONEY:
The estimated broad costs and benefits of the main intervention.
The main assumptions behind those calculations.
The evidence behind those assumptions.
The main uncertainties about the estimated costs and benefits.
The government’s objective is to improve the uptake of cost and clinically effective
innovations in the NHS, as assessed by NICE. There are a complex set of
interventions to address the policy aims, nationally and at a local level so it is not
possible to identify the costs and benefits of the main intervention. A number of the
interventions are about provision of information or cultural change within the NHS. It
19
Monitor Deloitte (2015) Genomics in the UK: an industry study for the Office of Life Sciences . Accessed:
https://www.gov.uk/government/publications/genomics-industry-study-uk-market-analysis
20 Monitor Deloitte (2015) Digital health in the UK: an industry study for the Office of Life Sciences. Accessed:
https://www.gov.uk/government/publications/digital-health-industry-uk-market-analysis
is possible to identify the costs of some specific interventions. For example, in the
Test Bed programme, the first wave of the programmes has access to funding of
£10m, which we expect to run for 2-3 years21.
We also know that the objectives of government and policy aims are set in the
context of a medicines bill in 2014-15 of over £14 billion22, with spending this year
expected to rise and the ever increasing public expectations of what healthcare can
deliver. We also recognise that the NHS currently faces a significant financial
challenge.
The AAR will also consider the costs and benefits for of a number of its
recommendations.
5.
TESTING AND EVALUATION:
 Any plans to measure the impact of the main policy intervention in this area.
 Any plans to evaluate the effects of the policy and their timing.
There are a number of evaluations being set up to look at previous policies such as a
review of the actions outlined in Innovation, Health and Wealth (IHW). Alongside this,
an evaluation of the new models of care, and technology and service redesign –
including test beds – are being set up, a review of EAMS – that will feed into the
AAR , on-going monitoring of the programmes, the Competitiveness Indicators and
the Innovation Scorecard.
In addition, the impact of the NIHR is measured on an ongoing basis with evidence
of impact measured both qualitatively and quantitatively, and the Department of
Health publishes an annual NIHR report.
We envisage that the final recommendations (in April 2016) and subsequent
interventions arising from the AAR will be evaluated following implementation.
21
NHS England: How much funding is available for the programme and how will it be awarded? Accessed:
https://www.england.nhs.uk/ourwork/innovation/test-beds/faqs/
22
DH analysis based on Primary care drugs spend is £8.2bn (DH Annual Report 2013/15
https://www.gov.uk/government/publications/department-of-health-annual-report-and-accounts-2014-to-2015) and Estimated net
spend including VAT and medical gases for secondary care drugs is £5.9bn (Monitor FT data and NHS trust data is available from gov.uk:
https://www.gov.uk/government/publications/nhs-trusts-accounts-data-for-2014-to-2015
https://www.gov.uk/government/publications/nhs-foundation-trusts-consolidated-accounts-201415).