Download Guidance Development – Jane Cowl & Tommy Wilkinson

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
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Grey literature and unpublished data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?’, ‘What is important to you?’ or ‘What is
your experience of care’ 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 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
The value of patient evidence
What insights does patient evidence offer us?
 Personal impact of living with a condition and experience of
care
 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
Evidence from experience of care
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
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
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
How this all works in practice: the
interactive group task
• You will be the technology appraisal committee
• You have a difficult decision to make regarding a
treatment for macular degeneration
• Different members will be required to represent
a different perspective:
Group A Clinical
Group B Public
Group C Health Economics
How this all works in practice: the
interactive group task
Choices available to the committee:
• Option A: Approve, recommending that the drug(s) are
used to treat the “best eye only”
• Option B: Approve, recommending that the drug(s) can
be used in both eyes that are affected by the condition
• Option C: Recommend that funding for the drug should
not be made available on the NHS (decline)
How this all works in practice: the
interactive group task
Perspectives:
• Clinical: Is the recommendation reflecting the
evidence base? How certain are we that the clinical
effect seen in RCTs will be reflected in practice?
• Public: Have all views been taken into account? Have
we thought more broadly about how this might affect
patients, their families and the wider public?
• Health Economics: Could we do more good by
investing elsewhere in the NHS?