Memorandum submitted by the Department
of Health (FC 00)
INVESTMENT IN
HEALTH RESEARCH
1. The Department of Health is the largest
departmental investor in research and development after the Department
for Business Innovation & Skills and the Ministry of Defence.
The Department of Health funds R&D through two main routes:
— the National Institute for Health Research
(NIHR)—specifically designed to deliver the Government's
research strategy Best Research for Best Health1; and
— the DH Policy Research Programme (PRP)—providing
the evidence base for policy development and evaluation of policy
implementation in health and adult social care.
2. The Department has made unparalleled
real terms increases in research funding over the previous and
current spending review periods, and this investment will rise
to over £1 billion in 2010-11. The achievements made
by the NIHR in implementing Best Research for Best Health
are described in its latest progress report.2 Since January 2009,
more than 300,000 participants have taken part in trials
and studies conducted through the NIHR Clinical Research Network,
and England has the highest national per capita rate of cancer
trial participation in the world.
RING-FENCED
RESEARCH AND
DEVELOPMENT BUDGET
3. The Department's budget for the NIHR
and the PRP has been ring-fenced since the beginning of the 2007 Comprehensive
Spending Review period. In 2010-11, a departmental saving of £62 million
will be achieved by transferring responsibility for research activity
from other departmental policy budgets to the ring-fenced R&D
budget. The research the ring-fenced budget currently funds will
continue as planned. Research activity previously funded from
other departmental budgets will be managed through the PRP from
2010-11. These changes will help to ensure consistent prioritisation
and quality measures with Value for Money across the department's
R&D investment.
4. The ring fence has ensured protection
of this budget from any front line pressures. The sustained and
protected investment through the budget is enabling DH to:
— deliver the vision set out in the Cooksey
Report for more effective translation of health research into
health and economic benefits in the UK, together with the Medical
Research Council (MRC) and other funding partners;
— ensure the availability and efficiency
of research infrastructure in the NHS to support clinical trials
and studies funded by the Research Councils, medical research
charities, industry, and other funders;
— respond rapidly to urgent priorities
such as swine flu;
— build longer term research capacity in
academic clinical medicine, social care, and other fields; and
— contribute to the funding of vital research
in cross-cutting priority areas such as obesity.
5. The NIHR provides extensive NHS infrastructure
support for translational and clinical research through its 12 Biomedical
Research Centres, 16 Biomedical Research Units, Clinical
Research Facilities for Experimental Medicine, and Clinical Research
Networks. The NIHR and MRC are developing a joint programme for
translational research and are working together on number of research
initiatives including the Efficacy and Mechanism Evaluation Programme,
Methodology Research Programme, and Patient Research Cohorts under
the auspices of the Office for Strategic Co-ordination of Health
Research (OSCHR).
6. The purpose of the NIHR Clinical Research
Network is to provide a world class health research infrastructure
to support clinical trials and other well designed studies funded
by both commercial and non-commercial organisations. The Network
ensures that patients and healthcare professionals from all parts
of England, and from all areas of healthcare, are able to participate
in and benefit from clinical research. Its existence improves
the quality, speed and co-ordination of clinical research by removing
the barriers to research in the NHS.
7. It is crucial for DH to have the research
resources, and access to the research capability and capacity,
to respond swiftly to urgent evidence needs. Discussions of rapid
research commissioning in swine flu began on 4 June 2009,
and an open, themed call was launched on 19 June. By 6 August,
fourteen NIHR projects were being funded. Approval for 100 hospitals
to participate in one study was arranged within five days. Mid-term
results from a serological study were published in The Lancet
on 21 January 2010.
8. A vibrant clinical academic community
is essential not only for first class health research but also
for innovative world class clinical care. Investment by DH has
contributed to a recent increase in total staffing levels. However,
there are concerns that 58% of the clinical academic workforce
are now aged 46 or over, compared with 53% in 2004. Some
specialties such as Pathology have reported declines in staffing
levels. Through NIHR, the Department is investing in large numbers
of Academic Clinical Fellowships (ACFs) and Clinical Lectureships
(CLs). These provide research exposure and experience for academically
gifted medical and dental trainees. NIHR funds over 250 news
ACFs and 100 CLs each year.
9. Social care is a research field to which
many disciplines contribute (among them social policy, psychology,
sociology, economics, demography and management) and is of increasing
importance in the context of trends in UK demographic change.
Historically there has been under-investment in the field and
DH is contributing to work to address this, for example through
establishment of the NIHR School for Social Care Research (in
operation since February 2009).
10. The Department is the largest UK funder
of mental health research and the Government's strategy for mental
health3 sets out planned action in this research field. One of
the six topic specific research networks that form part of the
NIHR Clinical Research Network is devoted to supporting mental
health research. It has already had a significant and positive
impact on the numbers of patients being recruited to take part
in clinical trials.
11. The Department's ring-fenced R&D
budget also enables successful collaboration with other government
departments on a wide range of cross-cutting research priorities
supporting Public Service Agreements. For example, DH led the
development of the cross-government research and surveillance
plan for obesity. The NIHR Health Technology Assessment (HTA)
and Public Health Research (PHR) programmes recently issued a
joint themed call for evaluating interventions in obesity. Both
programmes focus on evaluation, with an interest in cost-effectiveness.
The HTA programme evaluates interventions in the NHS and the PHR
programme evaluates public health interventions delivered in other
settings.
ECONOMIC IMPACT
OF HEALTH
RESEARCH
12. The vision of Best Research for Best
Health is to improve the health and wealth of the nation through
research. This is reinforced by the Cooksey Report, that made
recommendations to increase the translation of R&D into health
and economic benefit for the UK, both in the public and private
sectors.
13. Health Technology Assessment identifies
how drugs, devices, procedures, care settings, screening, and
other interventions can be used to maximise the benefits of investment
in health services, and may also identify ineffective products
or interventions that can be withdrawn. Examples of recent findings
from the NIHR HTA programme, and their implications for NHS costs,
are listed in an Appendix.
14. Various approaches have been developed
to assess the economic and financial impacts of health research.
These are discussed in a report published in 2006.4 A later study5
found that £1 spent on public and charitable research
in cardiovascular disease yields an estimated net return of 39p
per year in perpetuity, comprising 9p from health gains and 30p
from gains in Gross Domestic Product (GDP). Investment of £1 in
mental health research yields an estimated net return of 7p from
health gains and 30p from GDP gains. Other work in this area has
been undertaken by researchers at the London School of Economics.6
APPENDIX
Examples of recent findings from the NIHR Health
Technology Assessment programme and their potential implications
for cost to the NHS—prepared by the NIHR Evaluation, Trials
and Studies Coordinating Centre
01/14/10 Treatment of severe ankle sprain:
a pragmatic randomised controlled trial comparing the clinical
effectiveness and cost-effectiveness of three types of mechanical
ankle support with tubular bandage. The CAST trial (Cooke) Health
Technol Assess, 2009; Vol 13:13 www.hta.ac.uk/1309
Summary of findings—This trial suggests
that the most clinically and cost-effective treatment for pain
relief and recovery from severe ankle sprain, where patients cannot
put any weight through that leg, is a below the knee cast. However
neither treatment affected the long-term outcome and so a decision
about which brace to apply should incorporate an assessment of
likely compliance and acceptability to patients.
Importance to NHS—Ankle injuries are one
of the most common injuries seen in UK emergency departments.
It has been estimated that one ankle sprain occurs per 10,000 people
per day, most of which are due to sport or leisure activities.
A number of new devices have been developed
to treat severe ankle sprains and include a foam-padded walking
boot and ankle braces. However there is limited research on the
effectiveness of these new technologies compared to current treatments,
which are the use of tubular bandaging or a below knee plaster
cast. The CAST trial compared the clinical and cost-effectiveness
of four methods of ankle support for severe ankle sprain.
Cost to the NHS—The cost of treatment
to the NHS could rise significantly if newer devices were widely
adopted, with the foam padded boot costing about £215, including
fitting, and the ankle brace £39.23. Both are more expensive
than the standard treatments provided by the NHS, with a below
the knee plaster cast costing £16.46 and the tubular
bandage £1.44 which was less effective than the plaster
cast.
01/38/05 Blood glucose self-monitoring
in type 2 diabetes: a randomised controlled trial (DiGEM)
(Farmer), Health Technol Assess, 2009; Vol 13:15 www.hta.ac.uk/1330
Summary of findings—This study concluded
that the routine use of self-monitoring of blood glucose (SMBG)
with or without additional training, was associated with higher
costs and lower quality of life in patients with well controlled
non-insulin treated type 2 diabetes.
Importance to NHS—With the UK prevalence
of type 2 diabetes increasing, with estimates ranging from
3.5% - 5% of the population aged 20-79 years, ways to better
manage and improve the long-term outcomes for people with diabetes
are important.
Self-monitoring of blood glucose (SMBG) is a
technology that is frequently incorporated into self-management
interventions for diabetes, but has only been separately evaluated
in a limited number of trials. As a result of this lack of evidence,
clinical guidelines have differed in advice about the best way
to use SMBG. The HTA programme therefore commissioned the DiGEM
trial to clarify this clinical uncertainty.
Cost to the NHS—The DiGEM trial found
that self-monitoring of blood glucose was significantly more expensive
than standardised usual care, by £92 and £84 for
the less intensive SMBG.
The current NICE guideline (CG66), published
in May 2008 before DiGEM had published its findings, recommends
offering self-monitoring of plasma glucose to a person newly diagnosed
with type 2 diabetes only as an integral part of his or her
self-management education. Although not included in the guidelines
consideration, the findings of the trial are noted as potentially
important.
The results of the DiGEM trial will therefore
help inform the management of people with type 2 diabetes
in future and should contribute to a reduction of inappropriate
expenditure in this area as well as the provision of ineffective
or potentially harmful interventions to patients by the NHS.
02/10/02 A prospective randomised controlled
trial and economic modelling of antimicrobial silver dressings
versus non-adherent control dressings for venous leg ulcers: The
VULCAN trial (Michaels) Health Technol Assess, 2009; Vol 13:56 www.hta.ac.uk/1380
Summary of findings—This study found that
there is little to support the use of antimicrobial silver dressings,
compared with non-adherent dressings, in the treatment of venous
leg ulcers. However, the economic analysis showed a significantly
higher cost for those treated with antimicrobial dressings with
there being no difference in clinical outcomes.
Importance to the NHS—Venous leg ulcers
are a major health problem and result in considerable costs and
morbidity for health services. Chronic venous leg ulcers affect
more than three per cent of the elderly population in the UK.
Antimicrobial dressings have been widely adopted
without positive clinical evidence and the study surveys suggested
that silver-donating antimicrobial dressings have become widely
used. If this reflects national practice then the implication
is that the NHS could be spending several million pounds on dressings
each year with no evidence of clinical benefit.
Cost to the NHS—The annual cost to the
NHS is estimated at £450 million, mostly for dressing
materials and nursing time. The results of this trial show that
there is no evidence to justify the use of the more expensive
silver dressings in routine venous leg ulcer care, as they offer
no real clinical advantage or improvement in quality of life,
but are significantly more expensive. These findings could potentially
save the NHS millions of pounds.
05/39/06 Methods to identify postnatal
depression in primary care: an integrated evidence synthesis and
value of information analysis (Hewitt) Health Technol Assess,
2009; Vol 13:36 www.hta.ac.uk/1521
Summary of findings—The study found that
the accepted criteria for a postnatal depression screening programme
were not currently met. The use of formal identification methods
for detecting postnatal depression does not represent value for
money for the NHS.
The evidence also suggested that there is a
simple, safe, precise and validated identification strategy, that
in principle a suitable cut-off level could be defined and that
the strategy is acceptable to the population.
Importance to the NHS—Over 11% of women
experience major or minor postnatal depression six weeks postnatally.
Though clinically and cost-effective treatments are available,
less than half of cases of postnatal depression are detected in
routine clinical practice. Screening strategies using brief depression
questionnaires have been advocated but have attracted substantial
controversy and the effectiveness and value for money of these
strategies is uncertain.
Importance for clinical decision-making and
to patient outcomes—Current guidance from NICE recommends
routine screening for postnatal depression in primary care. However
the findings of this study suggest that this does not appear to
represent value for money for the NHS and both the NICE recommendation
and widespread current practice should be reviewed.
Cost to the NHS—Screening for postnatal
depression with one of the most widely used questionnaires, the
Edinburgh Postnatal Depression Scale, had an incremental cost-effectiveness
ratio of £41,103 per quality adjusted life year or QALY
(a combined measure of quantity and quality of life) compared
with routine care only.
The ratio for all other strategies looked at
in this study ranged from £49,928 to £272,463 per
QALY compared with routine care only. This is above the conventional
NHS cost-effectiveness threshold of £20-30,000 per QALY.
In contrast, the strategy of treating post natal depression without
using screening as is current practice represented good value
for money.
REFERENCES1 Best
Research for Best Health: a new national health research strategy:
the NHS contribution to health research in England. Department
of Health, January 2006.
2 Delivering Health Research: National Institute
for Health Research progress report 2008-091. Department of
Health, July 2009.
3 HM Government. New Horizons: a shared vision
for mental health. Department of Health, December 2009.
4 UK Evaluation Forum. Medical research: assessing
the benefits to society. Academy of Medical Sciences, May
2006.
5 Health Economics Research Group, Office of
Health Economics, RAND Europe. Medical research: what's it
worth? Estimating the economic benfits from medical research in
the UK. UK Evaluation Forum, November 2008.
6 McGuire A, Raikou M. Inferring the vlaue
of medical research to the UK. Working paper No: 5/2007. LSE
Health, January 2007.
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