Who is involved in making NICE guidance
recommendations and what evidence do they look at?
Jane Cowl, Senior Public Involvement Adviser
Tommy Wilkinson, Advisor (Health Economics), NICE International
Who decides what NICE will
recommend?
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Specialist staff employed by NICE
The Department of Health
Independent committees of experts
Independent committees of NICE staff & experts
NICE employed administration staff
NHS England
Clinical Commissioning Groups
NHS finance managers
True or False?
True or False?
True or False?
True or False?
True or False?
True or False?
True or False?
True or False?
Who decides what NICE will
recommend?
Independent committees
 Chair
 At least 2 lay members
 Health and social care professionals
(specialists and generalists)
 Care providers and commissioners
 Technical experts e.g. health economist
• 2 types: standing committees and topic specific groups
• Staff provide technical and administrative support
Guidance development phases
Scope development and consultation
Evidence reviews and economic analysis
Draft guidance development and consultation
Guidance quality assurance and publication
Implementation of guidance
Evidence informing committee’s work
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Reviews of research evidence (all NICE guidance)
Grey literature and unpublished data
Economic modelling
Manufacturers submissions
Expert testimony (patient and professional)
Stakeholder consultation (all NICE guidance)
Occasional additional consultation or fieldwork with
practitioners and patients
NICE recommendations based on best available evidence
The right type of evidence for the
question
The question dictates the most appropriate study design, for
example
 'What is the cause of this disease?' Cohort, case-controlled
study
 ‘What does it feel like?’ or ‘What is important to you?’
Qualitative research
 'What is the most clinically effective therapy?' Randomised
controlled trial (RCT)
 ‘What works best in diagnosing the condition?’ Observational
study or RCT
Includes systematic reviews of studies e.g. RCTs where available
The nature of evidence
Patient
evidence
High quality
patient care
(Relevant,
effective,
acceptable,
appropriate)
Clinical
evidence
Economic
evidence
Acknowledgement: Dr Sophie Staniszewska, RCN Research Institute, University of Warwick
Patient evidence
Where do we get patient evidence from?
 RCTs and other quantitative research
 Qualitative research
 Both published research and grey literature (e.g.
patient surveys)
 Patient testimonies and commentaries
 Committee members
 Consultation
The value of patient evidence
What insights does patient evidence offer us?
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Personal impact of living with a condition
People’s preferences and values
Outcomes that patients want from treatment or care
Impact of treatment or care on outcome, symptoms,
physical and social functioning, quality of life
 Risks, benefits and acceptability of a treatment or service
 Equality issues and considerations for specific sub-groups
New information
Example – people who self-harm
Focus group discussions with
people who self-harmed – they
were not routinely offered
anaesthesia for suturing wounds in
the emergency department
Nothing in the published research
to indicate this was an issue
The NICE guideline addresses the
issue in its recommendations
Adding to the evidence base
Example – Psoriasis
Clinical research told us the
amount of psoriasis was
what most affected the
quality of life.
Patients told us that the
location of the flare-up (e.g.
face or joints) was more
significant.
Narrative to contextualise
quantitative research
Example – promoting
physical activity
Public health guidance included focus on
girls and young women aged 11-18
Evidence from 15 UK qualitative studies of
adolescent girls on main barriers and
facilitators to being physically active
Informed recommendations on supporting
girls and young women and helping them to
be physically active
Patient perspectives – impact and
challenges
 Examples of positive influence of patient evidence on:
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Scoping and review questions
Evidence reviews
Guidance recommendations
Research recommendations
 Challenges
• Ensuring patient voices are heard
• The weighting of patient evidence
• Synthesising with clinical and economic evidence
Health Economics at NICE
Why consider health economics?
Opportunity Cost
• If the NHS spends more on
one thing, it has to do less
of something else (on the
margin)
• Could we do more good by
spending money in other
ways?
• The ‘opportunity cost’
is the value of the best
alternative use of resources
Cost effectiveness and the
ICER
COSTS
value of extra
resources used
Current
treatment
New
treatment
CONSEQUENCES
(EFFECT)
value of health gain
“COST EFFECTIVENESS” MEANS TO REFER TO COSTS AND EFFECTS
I
Incremental: extra, additional
C Cost: How much do we have to pay?
E Effectiveness: What do we get (in QALYs)?
R Ratio: unit per unit e.g. km/h - we use cost per QALY
Measuring health outcome – QALY
• What is a quality-adjusted life-year (QALY)?
– combines both length of life (LY) and health-related quality of life
(QA) into a single measure of health gain
– The amount of time spent in a health state is weighted by the
quality of life (QoL) score attached to that health state
– QoL is usually scored with ‘perfect health’=1 and death=0
1 QALY
=
=
=
one year of ‘perfectly healthy’ life for one person
two years of life with QoL of 0.5 for one person
one year of life with QoL of 0.5 each for two people
health-related quality of life
(utility)
Quality-Adjusted Life-Years
time (years)
Assessing cost effectiveness
The Threshold
Probability of rejection
1
• Uncertainty
• Features of condition
• Equity judgments
• Availability of treatments
• Innovation
• Uncaptured
health gain
0
£10K
£20K
£30K
Cost per QALY
£40K
£50K
Assessing cost effectiveness
Weighing up the benefits, harms and costs
Cost (£)
New treatment more expensive...
... but some savings from reduced
need for care in future
New
treatment
Current
practice
New treatment
more effective...
... but harmful side effects
for some people
Effect (QALYs)
Assessing cost effectiveness
Value for money
Cost (£)
Treatment options in the
shaded region are judged to
provide good value for money
(are ‘cost effective’)
New treatment dominated
Cost-per-QALY threshold
(‘willingness to pay’)
High extra cost;
low QALY gain
Low extra cost;
high QALY gain
Effect (QALYs)
New treatment dominates
Considerations beyond efficiency
“Decisions about whether to recommend
interventions should not be based on evidence
of their relative costs and benefits alone. NICE
must consider other factors when developing
its guidance, including the need to distribute
health resources in the fairest way within
society as a whole.”
NICE Social Value Judgement report
http://www.nice.org.uk/aboutnice/howwework/socialvaluejudgements/socialvaluejudgements.jsp