Transcript Economic and ethical issues in ultra

A comparison of technology coverage
decisions in the US and the UK:
seeing the NICE side of costeffectiveness analysis
Stirling Bryan, PhD
Harkness Fellow in Health Care Policy 2005/6
Visiting Faculty, Center for Health Policy, Stanford
Professor of Health Economics, Birmingham, UK
Overview
 The technology coverage issue
 The UK position and the National Institute for Health &
Clinical Excellence (NICE)
 Some research findings on the use of cost-effectiveness
analysis (CEA) in coverage decisions in the UK
 My understanding of the US position (or my
misconceptions after 2 days!)
 Some research questions (for my Harkness project)
Technology coverage
 What is it?
– a decision not to ‘cover’ a technology indicates that its
cost will not be reimbursed as part of the insurance
package
– it involves setting limits on the health care services that
can be accessed or provided
 Who makes coverage decisions?
– private health plans and government health insurance
programs both make coverage decisions
Coverage decisions in the UK
 Local level – wide variety of primary and
secondary care decision-making bodies
 National level – National Institute for Health &
Clinical Excellence (NICE)
– one of its functions is to appraise new and existing
health technologies
– coverage decisions based on explicit criteria and are
informed by an independent assessment of evidence,
including an economic evaluation
– submissions also received from the sponsor of the
technology, and other expert bodies
Horizon Scanning
Long-list of
technologies
National guidance
Prioritisation
Industry submissions
NICE
Appraisals Committee
Patient &
professional
input
Review and economic
analysis
Short-list
of topics
Academic HTA team
Examples of guidance
“Donepezil, rivastigmine and galantamine
are not recommended for use in the
treatment of mild to moderate Alzheimer’s
disease (AD).”
“Riluzole is recommended for the treatment
of individuals with the amyotrophic lateral
sclerosis (ALS) form of Motor Neurone
Disease (MND).”
NICE Appraisal Committee
membership (n=28)
Area of expertise
Number of Committee
members
Medical (e.g. GP, physician,
surgeon)
12 (43%)
Other clinical (e.g. nurse,
pharmacist)
4 (14%)
Methodologists (e.g. health
economist, statistician)
5 (18%)
Managers
3 (11%)
Patient ‘advocate’
2 (7%)
Manufacturer ‘representative’
2 (7%)
The drug itself has no side effects …
but the number of health economists needed to
prove its value may cause dizziness and nausea
UK-based research
 Research questions
– To what extent, and in what ways, is costeffectiveness information used in coverage
decision-making in the UK?
– How might the impact of CEAs be increased,
particularly in relation to issues of accessibility
and acceptability?
Research methods: NICE case
study
 Background interviews with members of NICE
appraisals team
 Focus on 7 technology appraisals
– Documentary analysis
– Observation of committee meetings
– Interviews with selected members of Committee
 Additional, non-technology specific interviews with
Committee members
The AC interview sample (n=28)
Area of expertise
Medical (e.g. GP, physician,
surgeon)
Number of Committee
members interviewed
13 (46%)
Other clinical (e.g. nurse,
pharmacist)
3 (11%)
Methodologists (e.g. health
economist, statistician)
6 (21%)
Managers
2 (7%)
Patient ‘advocate’
3 (11%)
Manufacturer ‘representative’
1 (4%)
The ‘importance’ of the
economic analysis
People have come to accept that the economic
evaluation is more crucial than they thought. I
think a lot of them came along two years ago
with the idea that … you had to listen to the
economist say something.
… they’ve moved to saying ‘this is all so
complicated, just tell us what the ICER is!’
because they’ve actually realised that it is a
crucial issue.
Political
Concepts &
processes
Appraisal Committee
composition
The ‘workings’ of
the Committee
Information
processing
Practical
Roles of
Committee members
Committee
procedures
Conceptual
challenges
QALYs
Practical issues
relating to economic
analyses
Equity
concerns
Political
Concepts &
processes
Appraisal Committee
composition
The ‘workings’ of
the Committee
Information
processing
Practical
Roles of
Committee members
Committee
procedures
Conceptual
challenges
QALYs
Practical issues
relating to economic
analyses
Equity
concerns
Information processing (1)
 Ordinal approach to considering the evidence (i.e.
‘effectiveness’ then ‘CE’):
My first consideration when I look at this is ‘does this
treatment actually work?’ … obviously it has to be
clinically effective in order to be cost-effective
I don’t believe effectiveness should be a criterion for
NICE decisions. Now that’s a fundamental conceptual
problem with NICE that they require clinical effectiveness
before we go on to examine cost effectiveness.
Information processing (2)
Difference in cost
NW
NE
Difference in
effectiveness
SW
SE
Committee procedures
 The threshold:
There is a feeling when we get beyond £30,000 per QALY
we’re running into trouble.
I do sometimes have reservations about the figure of
£30,000 per QALY. Where does the figure come from?
Who determines where the cut-off point should be? …
This magic figure of £30,000 keeps popping up but I lack
the underlying knowledge to be able to challenge.
My biggest criticism … is basically we are funding things at
a level that actually the NHS cannot fund – that the [cost
per] QALY figure is far too high, it should be much lower.
Political
Concepts &
processes
Appraisal Committee
composition
The ‘workings’ of
the Committee
Information
processing
Practical
Roles of
Committee members
Committee
procedures
Conceptual
challenges
QALYs
Practical issues
relating to economic
analyses
Equity
concerns
Conceptual challenge: equity
 No strong evidence currently on which to base equity
weighting:
I think there’s a sort of recognition at the moment, that
we have no basis for doing the weighting.
 Some implicit weighting is being done:
At the end of each of these discussions people say, ‘well
we have no basis for doing this so let’s just treat a QALY
as a QALY regardless’. But where that isn’t true, I think,
is in relation to children … although people don’t
necessarily explicitly state it, I think everybody tends to
give it more weight.
Political
Concepts &
processes
Appraisal Committee
composition
The ‘workings’ of
the Committee
Information
processing
Practical
Roles of
Committee members
Committee
procedures
Conceptual
challenges
QALYs
Practical issues
relating to economic
analyses
Equity
concerns
Practical issues
 Understanding of the economic evaluation by Committee
members:
Some are probably not all that clear as to how it is done
… I think there are certainly a number who probably don’t
understand a word of what is going on in the health
economics bit. … and some people do keep very quiet
when the health economics is being talked about and
that’s very noticeable.
There’s a fuzzy belief that people do understand costeffectiveness, because it is so important we all
understand it, but the actual principles and so on are not
well understood.
Political
Concepts &
processes
Appraisal Committee
composition
The ‘workings’ of
the Committee
Information
processing
Practical
Roles of
Committee members
Committee
procedures
Conceptual
challenges
QALYs
Practical issues
relating to economic
analyses
Equity
concerns
The US, coverage and CEA
“Coverage policy is tightly linked to the affordability
of health insurance, and hence the rate of
uninsurance … [and] also influences the types of
medical care Americans receive.
Absent from these [health care reform] debates is
any systematic discussion of processes to choose
the medical goods and services that health
insurance should cover.”
Garber (2004, p284)
“We currently lack a consensus on principles that
would tell us how to distribute health care fairly.”
Daniels and Sabin (2002, p3)
Medicare coverage
“One of the most difficult policy issues confronted
in any decision on coverage criteria is the role of
cost-effectiveness analysis in deciding what is to
be considered reasonable and necessary.”
Tunis (2004, p2197)
“To Medicare, CEA has been an elephant in the
living room, officially ignored despite its obvious
importance.”
Neumann (2005, p148)
A hopeful future?
“After a decade of failed attempts to integrate CEA
as a criterion for coverage, prospects for its
ultimate adoption … appear dim.
These attempts have revealed the strength of
antagonism in the US towards openly confronting
resource constraints. If Medicare officials – and
politicians – learned anything from the experience,
it was the political folly of trying to ration honestly.”
Neumann (2005, p149)
Harkness project
 Central research questions
– What principles and processes underlie coverage
decisions in the US, what use is made of information on
the cost-effectiveness of health technologies and, if use
is limited, why is this the case?
 Objectives
– In the main agencies concerned with the finance and
delivery of health care in the US, to describe the
principles underlying coverage policy and the processes
employed
– For selected recent coverage decisions, to explore the
‘impact’ of using a CE criterion
– To elicit the views of stakeholders (including the general
public) on coverage policy principles and processes,
and specifically the use of CE criterion