Why NHS must embrace Real World Data

SVMPharma Ltd

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Why the NHS must embrace Real World Data

© 2015 SVMPharma Ltd. All rights reserved. 2

Contents

EXECUTIVE SUMMARY 3

INTRODUCTION 4

WHAT IS REAL WORLD DATA? 4

DOES THE NHS USE REAL WORLD DATA? 4

WHAT ARE THE OPTIONS FOR DATA COLLECTION IN THE NHS? 5

CONCLUSION 7

REFERENCES 8

Why the NHS must embrace Real World Data

© 2015 SVMPharma Ltd. All rights reserved. 3

Executive Summary

The unprecedented operational and financial challenges facing the National Health

Service (NHS) have been well documented and are hardly ever out of the news. The

massive gap in NHS funding in recent years and pressure on services caused by an

aging population with multiple long term conditions are just some of the more widely

reported reasons for the crisis .1 Various thinktanks and policy makers have put

forward solutions to help reduce the pressures on the NHS . Primary among these are

the integration of health and social care, greater emphasis on disease prevention and

the introduction of new models of care into the NHS structure.2 In this paper, we

argue that in order to navigate the difficult balance between financial sustainability

and optimal performance the NHS needs to be more proactive in the collection and

analysis of Real World Data (RWD) and exploit the multiple opportunities for

commissioning RWD analysis at a local and national level . The current status quo and

potential benefits to the NHS of gathering this type of data are also explored.

Why the NHS must embrace Real World Data

© 2015 SVMPharma Ltd. All rights reserved. 4

Introduction There is a broad consensus that in order for the

NHS to continue to meet the objectives and values

for which it was set up, it must change the way in

which it functions as an organisation.3 A downturn

in the UK economy over the last decade or so has

resulted in reduced government funding for the

NHS. This, coupled with increased demand on

services by an aging population means that the

NHS now operates under remarkable financial and

operational pressure.

It is estimated that if the current trajectory of flat

government funding and growth in demand is

maintained, the NHS in England will experience a

funding deficit of around £30 billion per year by

2020/21.4 The NHS itself acknowledges that it

needs to come up with smarter ways of resolving

the financial and productivity challenges it faces,

by promoting intelligent use of research data.5 The

size and scale of the NHS6 and its capacity to offer

a cradle-to-grave service to everyone means that it

possesses an unsurpassed repository of healthcare

data which can be a huge source of information to

improve health outcomes.

What is Real World Data?

The concept of gathering Real World Data has

largely evolved in recent years as a result of the

increased interest by health technology

assessment (HTA) agencies in data which

demonstrates the value and effectiveness of

healthcare interventions. Real World Data (RWD)

collection encompasses anything outside

traditional randomised controlled trials (RCTs) and

goes beyond what is normally investigated during

phase III clinical trials in the evaluation of normal

clinical practice.7

There is increasing acknowledgement that classical

RCTs while crucial to determine the safety and

efficacy of a medicine, are inadequate to evaluate

effectiveness in a practical real-life setting.8 .RWD

may be sourced from patient databases and

disease registries (e.g. Hospital Episodes Statistics

dataset or Clinical Practice Research Datalink),

patient and population surveys, patient reported

outcome measures (PROMS), patient reported

experience measures (PREMS), observational

studies, clinical audits and service evaluations.

Does the NHS use RWD?

In the UK, the NHS is the predominant source of

clinical and patient data and it is reasonable to

expect that information contained within the data

would be routinely used as a performance

management tool within the organisation.

However, this potential is yet to be realised

because of an apparent lack of awareness of the

concept and its value to decision making. At

present, the principal source of hospital data in

England is the Hospital Episodes Statistics (HES)

dataset. It contains over 125 million records from

hospital Accident and Emergency, in-patient and

outpatient departments every year.9 Analysis of

the HES dataset is

useful to monitor

quality and safety of

clinical procedures

across hospitals and

predict trends in

hospital activity,

resource use and

disease patterns.

Unfortunately, many

clinicians, commissioners and managers remain

largely unaware of the existence of HES or are

apathetic to its usefulness as a strategic planning

and clinical safety tool. 10 These stakeholders are

largely restricted to the Secondary Uses Service

(SUS) dataset which provides relatively basic

information on patients’ hospital procedures and

has problems of poor quality and incomplete

data.11 Clinicians frequently exhibit a distrust of the

integrity of available data and can be suspicious of

the motives behind data collection, questioning

whether the process might be used as a cost-

cutting exercise or an opportunity to exert more

managerial influence over them. 12 Many clinical

audits frequently run in hospitals or the medicines

audits carried out by CCG medicines management

teams do not achieve enough clinician engagement

from the outset and can often focus on a narrow

However, this

potential is yet to

be realised

because of an

apparent lack of

awareness of the

concept and its

value to decision

making.

Why the NHS must embrace Real World Data

© 2015 SVMPharma Ltd. All rights reserved. 5

cost-cutting objective. These audits present an

excellent opportunity to gather useful data from

patient records and managers should do more to

engage clinicians and patients to develop broader

outcomes-based objectives which focus on aligning

patients, clinicians and managers’ needs. Analysed

data can potentially

reveal hitherto unseen

opportunities to

optimise resource use

and capacity, drive

efficiency and

promote positive

patient outcomes. This

must be the driving

force behind the

initiation of such

projects.

And there are signs that real world evidence

increasingly influences how the NHS makes

decisions. The controversial off-label use of

bevacizumab (Avastin) in place of ranibizumab

(Lucentis) in the treatment of wet age-related

macular degeneration (AMD) offers a case in

point.13 Real life clinical practice has shown that

both treatments lead to similar outcomes and

many clinicians are willing to use the unlicensed

but cheaper bevacizumab for treatment of wet

AMD. The NHS must strive to routinely evaluate

health interventions in this way to drive access to

innovative treatments and optimise resource use.

It is notable that health technology assessment

bodies are also starting to acknowledge the

importance of using RWD to evaluate the true

value of health technologies.

The National Institute for Health and Care

Excellence (NICE) has indicated its willingness to

explore additional drug analysis designs other than

traditional clinical trials to aid decision-making. It

is, together with other stakeholders across Europe

working to develop standardised methodology for

incorporating RWD into the drug development and

reimbursement process.14 Another significant

observation about data that is currently available

to stakeholders is that they are mainly

retrospective, reporting what has already occurred

(e.g. the number of patients that have had a fall or

perhaps had a drug allergy), but not what is

happening at present or what may happen in

future. In order to maximise the opportunities that

real life data presents, the NHS needs not only to

collect and analyse data, but attempt to gain an

insight into the future by using innovative

predictive analytics tools. Predictive analysis

involves the use of technology and statistical

modelling methods to search through massive

amounts of data and analysing these to predict

individualised patient outcomes.15 This approach

has the capability to provide solutions to a range of

healthcare problems, from assessing individual

patients’ risk of contracting disease and identifying

the most suitable treatments to reducing

readmission rates and predicting healthcare

workforce requirements.16

A newly established National Information Board

(NIB) charged with defining information

technology strategy for the health and care system

recently set out a framework for the

transformation of care quality and outcomes

through data and technology. It plans to make

patient records accessible online in real time and,

enable data integration across various health and

care pathways.17 In addition to these, the NIB

would do well to actively embrace the concept of

predictive analytics so as to tap into the

opportunities it offers for transforming healthcare

and reach out to partners both within and outside

of the NHS to ensure that the organisation does not

miss out on what many observers consider to be

the next big revolution in healthcare.18

What are the options for data

collection in the NHS?

RWD evaluation has for the most part been driven

by the life sciences industry primarily to

demonstrate the real world value and

effectiveness of health technologies to

reimbursement authorities. Some of these

projects have been undertaken under a joint

working arrangement between industry and the

NHS where both parties pool together skills and

Analysed data can

potentially reveal

hitherto unseen

opportunities to

optimise resource

use and capacity,

drive efficiency

and promote

positive patient

outcomes

Why the NHS must embrace Real World Data

© 2015 SVMPharma Ltd. All rights reserved. 6

resources in order to achieve aligned and agreed

objectives which are targeted to improve patient

outcomes.

The Salford Lung Study which was a collaboration

between the NHS, Manchester University and

Glaxo SmithKline is lauded as a prime example of

this kind of arrangement.19 While there exists vast

opportunity for similar mutually beneficial

alliances to be forged between the NHS and the life

sciences industry this has yet to happen on a large

scale. There are inadequate mechanisms to foster

transparency and trust between the involved

stakeholders (patients, clinicians, commissioners,

regulators and the pharmaceutical industry)

regarding the benefits

of data collection and a

lack of assurance that

appropriate safeguards

to protect personal data

are in place.20 Better

communication and

transparency about the

benefits of RWD

together with the

development of a

robust governance

process for the handling of health data mutually

acceptable to all stakeholders, are some of the

steps which commentators suggest are required to

build trust.21

In contrast to joint working arrangements, the NHS

could also explore the use of innovative RWD

analysis to support commissioning decisions by

working directly with expert consultancies in the

field. Particularly in the area of specialised

commissioning for cancer and rare diseases,

commissioners can use intelligent data analysis to

better understand disease treatment pathways

and the impact of health interventions on

healthcare resources and outcomes. Many

hospital trusts already commission consulting firms

to gather data on patient experience and

satisfaction (e.g. the NHS Friends and Family Test22)

and may derive further benefit from tapping into

data analytics expertise within these consultancies.

A major advantage of this option is the ability to

conduct independent projects which are free from

bias of interested parties (commissioners or

industry).

Commissioners and clinicians may also choose to

proactively collect “in-house” data to support local

clinical and

commissioning

decision-making. The

routine audits carried

out in primary care and

hospitals must start to

move beyond narrow

cost-saving goals and

more towards

collecting data to

establish “what really

works” in real life clinical practice. Regional

stakeholders should take a cue from NHS

England’s, “Commissioning through Evaluation”

program which aims to gather real world data on

innovative health treatments that are not routinely

funded due to a lack of evidence.23 This is

particularly relevant to those services and

treatments that are accessed by a relatively small

number of patients.

Clinical commissioning groups (CCGs), hospitals

and regional therapeutic guidelines bodies should

collaborate to develop local “commissioning

hotspots” for these treatments. Real life outcomes

data and information obtained from these

hotspots may then be shared to support decision

making across health economies in the same

region. Commissioners in the North East of

England used this approach to support a decision

to fund an innovative treatment, Xiapex (a

collagenase injection used in the treatment of

Dupuytrens contracture).Clinical audit data

demonstrated that Xiapex enhanced patient

experience and cost-effectiveness, leading to a

positive decision by the North East Treatment

Advisory Group (NETAG).24 Xiapex has since been

approved for use in Scotland and Wales and in

some CCGs across England. More recently, doctors

at the Chelsea and Westminster Hospital in London

carried out a real world clinical practice audit of the

effects of dapagliflozin, a new treatment for type 2

diabetes, and compared their results to those

Move beyond

narrow cost

saving goals and

more towards

collecting data to

establish ‘what

really works’ in

real life clinical

practice There are

inadequate

mechanisms to

foster

transparency and

trust between

stakeholders

regarding the

benefits of data

collection

Why the NHS must embrace Real World Data

© 2015 SVMPharma Ltd. All rights reserved. 7

reported in clinical trials.25 The outcome of this

work supported the trust’s decision to commission

dapagliflozin and make it accessible to eligible

patients even before the treatment was approved

by NICE. In addition to improving patients’ access

to innovative treatments, this approach can foster

closer ties between stakeholders and positively

impact service redesign and the development of

mutually beneficial payment mechanisms.

Whatever option is chosen must be overseen by a

robust data governance protocol which ensures

that the process maintains the integrity of

individual patients’ privacy and confidentiality.

Conclusion It is clear that there is huge potential for RWD to

revolutionise healthcare delivery as we know it.

The current NHS leadership has committed to

promoting innovation and the use of RWD in its

five year plan to transform care,26 and while they

have been generally well received, these plans

stand the risk of remaining just that, if the will and

commitment to implement them does not trickle

down to local grassroots NHS stakeholders.

Overflowing accident and emergency

departments, delayed hospital discharges and the

use of health interventions with inconclusive

treatment outcomes are just some of the real

everyday issues facing the health service. To better

understand these issues and help drive innovative

solutions to solve them, local NHS managers must

invest in RWD.

Data monitoring and analytics can, amongst other

things, help hospitals cut down on administrative

costs, enhance clinicians’ real time decision making

capabilities, improve co-ordination across care

pathways as well as enhance the patient

experience.27 Public hesitation over the extension

of healthcare data use (as observed with the

current debate over care.data)28- must be matched

with adequate information and re-assurance to the

public about a transparent governance mechanism

which safeguards patients’ privacy. Despite all of

its problems, the NHS still ranks as one of the most

efficient healthcare systems in the world.29

However, in order for it to remain so, and continue

to be at the forefront of developing cutting edge

solutions to healthcare challenges, it cannot afford

to conduct business as usual. The adoption of a

top-to-bottom culture of working with Real World

Data offers a viable opportunity to achieve this.

CONTACT US

Real World Evidence Influence Mapping Patient Experience Healthcare Data Analytics

Why the NHS must embrace Real World Data

© 2015 SVMPharma Ltd. All rights reserved. 8

References

1. Ham, Chris. "Reforming the NHS in England: opportunities

and challenges. “ Medico-Legal Journal 81.1 (2013): 2-17.

2. Goodwin, Nick, et al. "Integrated care for patients and

populations: Improving outcomes by working together.”

London: King’s Fund (2012).

3. The NHS Constitution: The NHS belongs to us all

https://www.gov.uk/government/uploads/system/uploads

/attachment_data/file/170656/NHS_Constitution.pdf

4. Adam Roberts, Louise Marshall and Anita Charlesworth.

The funding pressures facing the NHS from 2010/11 to

2021/22: A decade of austerity? The Nuffield Trust (2012)

http://www.nuffieldtrust.org.uk/sites/files/nuffield/12120

3_a_decade_of_austerity_full_report_1.pdf

5. Innovation, Health and Wealth. NHS White Paper (2011)

http://webarchive.nationalarchives.gov.uk/201301071053

54/http:/www.dh.gov.uk/prod_consum_dh/groups/dh_dig

italassets/documents/digitalasset/dh_134597.pdf

6. NHS Workforce: Summary of staff in the NHS: Results from

September 2013 Census. Health and Social Care

Information Centre (2014)

7. Real Life Data : A Growing Need accessed 30/03/15

http://www.ispor.org/news/articles/oct07/rld.asp

8. The Vision for Real World Data – Harnessing the

Opportunities in the UK .Association of the British

Pharmaceutical Industry(ABPI) accessed 30/03/15

http://www.abpi.org.uk/our-

work/library/industry/Documents/Vision-for-Real-World-

Data.pdf

9. Hospital Episodes Statistics (HES) Health and Social Care

Information Centre http://www.hscic.gov.uk/hes

10. Hospital Episode Statistics (HES): Improving the quality and

value of hospital data. A discussion document. Academy

of Medical Royal Colleges (2011)

11. NHS Hospital Data and Datasets: A Consultation. Health

and Social Care Information Centre

(2013)

12. Are clinicians engaged in quality improvement? The Health

Foundation (2011)

http://www.health.org.uk/public/cms/75/76/313/2440/Ar

e%20clinicians%20engaged%20in%20quality%20improvem

ent.pdf?realName=y8NfS4.pdf

13. Steinbrook, Robert. "The price of sight—Ranibizumab, Bevacizumab, and the treatment of macular degeneration.” New England Journal of Medicine 355.14 (2006): 1409-1412.

14. IMI GetReal project https://www.nice.org.uk/about/what-

we-do/research-and-development/imi-getreal-project

15. Winters-Miner, Linda A. Seven ways predictive analytics

can improve healthcare Elsevier Connect (2014)

http://www.elsevier.com/connect/seven-ways-predictive-

analytics-can-improve-healthcare

16. Jeff Elton, Arad Ural Predictive Medicine Depends on

Analytics. Harvard Business Review (2014)

https://hbr.org/2014/10/predictive-medicine-depends-on-

analytics/

17. Personalised Health and Care 2020 Using Data and

Technology to Transform Outcomes for Patients and

Citizens. A Framework for Action. National Information

Board (2014)

https://www.gov.uk/government/uploads/system/uploads

/attachment_data/file/384650/NIB_Report.pdf

18. Groves, Peter, et al. "The ‘big data ‘revolution in

healthcare.” McKinsey Quarterly (2013).

19. New, John P., et al. "Obtaining real-world evidence: the Salford Lung Study. “ Thorax (2014): thoraxjnl-2014.

20. Weitzman, Elissa R., et al. "Willingness to share personal health record data for care improvement and public health: a survey of experienced personal health record users.” BMC medical informatics and decision making 12.1 (2012): 39.

21. Taylor, K .Building trust in the collection and use of real

world health data. Deloitte Blogs (2014)

http://blogs.deloitte.co.uk/health/2014/06/building-trust-

in-the-collection-and-use-of-real-world-health-data.html

22. The NHS Friends and Family Test NHS Choices.

http://www.nhs.uk/nhsengland/aboutnhsservices/pages/n

hs-friends-and-family-test.aspx

23. NHS England Commissioning through Evaluation

http://www.england.nhs.uk/2013/09/26/com-through-

eval/

24. Collagenase (Xiapex®) for Dupuytrens contracture NETAG

Decision Summary Notice

http://www.netag.nhs.uk/files/recommendations/NETAG%

20decision%20summary%20notice%20-

%20Collagenase%20-Xiapex-

%20for%20dupuytrens%20contracture%20-Mar2012.pdf

25. McGovern, Andrew P., et al. "Dapagliflozin: Clinical practice compared with pre-registration trial data." British Journal of Diabetes & Vascular Disease 14.4 (2014): 138-143.

26. Five Year Forward View. NHS England (2014)

http://www.england.nhs.uk/wp-

content/uploads/2014/10/5yfv-web.pdf

27. K.Brimmer 5 ways hospitals can use data analytics.

Healthcare IT News accessed 08/04/2015

http://www.healthcareitnews.com/news/5-ways-hospitals-

can-use-data-analytics

28. Care.data is in chaos. It breaks my heart. Ben Goldacre

The Guardian (February 2014)

http://www.theguardian.com/commentisfree/2014/feb/28

/care-data-is-in-chaos

29. Karen Davis, Kristof Stremikis, David Squires, and Cathy

Schoen Mirror, Mirror on the Wall: How the Performance

of the U.S. Health Care System Compares Internationally

The Commonwealth Fund (2014)

http://www.commonwealthfund.org/~/media/files/publica

tions/fund-

report/2014/jun/1755_davis_mirror_mirror_2014.pdf

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CONTACT SVMPHARMA

Vaneet NayarDirector SVMPharma

enquiry@svmpharma.com

Tel: +44 (0) 1252 417030

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