Balancing costeffectiveness with other values: the NICE experience

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Balancing cost-effectiveness with other values
the NICE experience

• Stirling Bryan
• Department of Health Economics

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Overview

• Introduction to the National Institute for Health
  Clinical Excellence (NICE)
• Cost-effectiveness analysis as a key driver of
  NICE decisions
• The NICE equity and social value principles

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The United Kingdom
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NICE Programmes

• Technology appraisals
• Criteria include both clinical and cost
  effectiveness
• Clinical guidelines
• Criteria include both clinical and cost
  effectiveness
• Public health guidance
• Criteria include both effectiveness and cost
  effectiveness
• Interventional procedures
• Guidance on safety and efficacy

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Technology coverage decisions in England

• Local level main budget holders are the PCTs
  but wide variety of decision-making bodies
• National level NICE
• coverage decisions based on explicit criteria,
  informed by evidence review and economic
  evaluation
• submissions received from independent academic
  team, the sponsor of the technology, and other
  expert bodies

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Consultation on evidence
13 weeks
4 weeks

• 1st Committee meeting
• preliminary
• recommendations

14 weeks
Review
Consultation on preliminary recommendations
4 weeks
2st Committee meeting ? final guidance
Appeal (or not)
14 months
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NICE Appraisal Committee membership (n28)
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NICE reference case for CEA
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Example CEA anakinra for RA
Guidance Anakinra should not normally be used
as a treatment for rheumatoid arthritis. It
should only be given to people who are taking
part in a study on how well it works in the long
term.
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The importance of CEA at NICE

• Secretary of States Direction to NICE
• NICE should consider The broad balance of
  clinical benefits and costs
• Bryan et al (2007)
• I think economic evaluation was regarded as
  being important from day one.
• It the CEA seems to me to be the clincher
  really. If its too high then its not going to
  get funded.
• NICE social value principle 2
• NICE must take into account the relative costs
  and benefits of interventions (their 'cost
  effectiveness') when deciding whether or not to
  recommend them.

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The drug itself has no side effects but the
number of health economists needed to prove its
value may cause dizziness and nausea
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The US and this debate

• Britain Stirs Outcry by Weighing Benefits of
  Drugs Versus Price
• Millions of patients around the world have taken
  drugs introduced over the past decade to delay
  the worsening of Alzheimer's disease.
• But this year, an arm of Britain's government
  health-care system, relying on some economists'
  number-crunching, said the benefit isn't worth
  the cost. It issued a preliminary ruling calling
  on doctors to stop prescribing the drugs.
• THE WALL STREET JOURNAL November 22,
  2005 Page A1

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Committee procedures the threshold

• There is a feeling when we get beyond 30,000
  per QALY were 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?
• My biggest criticism is basically we are
  funding things at a level that actually the NHS
  cannot afford that the cost per QALY figure
  is far too high, it should be much lower.
• Bryan et al (2007)

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Birch Gafni (2007) Economists dream or
nightmare? HEPL

• The efficiency of adopting the new intervention
  depends crucially on where the additional
  resources required to support the new
  intervention are to be taken from and at what
  opportunity cost.

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NICE and procedural justice

• Framework 'accountability for reasonableness
  (Daniels Sabin, 2002)
• Publicity
• Relevance
• Challenge and revision
• Regulation

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NICE reference case and distributive justice
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NICEs social value principles

• Principle 3
• 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.
• Principle 4
• If NICE decides not to recommend use of an
  intervention with a cost per QALY gained within
  or below the range 20,000 to 30,000 per QALY
  gained, or decides it will recommend use of an
  intervention within or above this range, it must
  explain the reasons why.

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NICEs social value principles

• Principle 5
• Although NICE upholds the right of individuals to
  make their own decisions about their care, this
  should not lead NICE to recommend interventions
  that are not effective and cost effective for the
  NHS as a whole.
• Principle 7
• NICE can recommend that use of an intervention is
  restricted to a particular group (e.g. people
  under or over a certain age) but only in certain
  circumstances. There must be clear evidence about
  the increased effectiveness of the intervention
  in this subgroup, or other reasons relating to
  fairness for society as a whole, or a legal
  requirement to act in this way.

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Procedural and distributive justice coming
together

• Principle 6
• NICE should consider and respond to comments it
  receives about its draft guidance, and change it
  where appropriate. But NICE must always use its
  own judgement to ensure that what it recommends
  is cost effective and takes account of the need
  to distribute health resources in the fairest way
  within society as a whole.

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Appraisal Committee composition
Roles of Committee members
Political
The workings of the Committee
Conceptual challenges
Concepts processes
Information processing
Committee procedures
QALYs
Equity concerns
Practical issues relating to economic analyses
Practical
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Conceptual challenge QALYs

• The positives of QALYs
• They really do allow us to begin to compare
  hearing aids to insulin pumps to MS drugs. Now
  there are a lot of problems with them but
  without that it becomes very difficult to do
  anything meaningful in terms of decision making.
• The problem, drawing on the example of MND
• When people with MND are looking forward over
  that really quite dire prospect, having a few
  weeks or a few months of better quality of life
  might be valued much more highly than just
  assigning a QALY weight.

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Conceptual challenge equity

• No strong evidence currently on which to base
  equity weighting
• I think theres 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
  lets just treat a QALY as a QALY regardless.
  But where that isnt true, I think, is in
  relation to children although people dont
  necessarily explicitly state it, I think
  everybody tends to give it more weight.

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And to conclude

• While we recognise that there are aspects of
  NICEs methods that could stand building, on
  balance we think that UK health economists should
  sleep more soundly at night for its presence
• Gold Bryan (2007)

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More in

• Bryan S, Williams I, McIver S. Seeing the NICE
  side of cost-effectiveness analysis A
  qualitative investigation of the use of
  cost-effectiveness analysis in NICE technology
  appraisals. Health Economics 200716(2)179-193
• Williams I, Bryan S, McIver S. How should
  cost-effectiveness analysis be used in health
  technology coverage decisions? Evidence from the
  NICE approach. Journal of Health Services
  Research Policy 200712(2)73-79
• Williams I, Bryan S. Cost-effectiveness analysis
  and formulary decision making in England. Social
  Science Medicine 2007652116-2129
• Gold M, Bryan S. Some reasons to be cheerful
  about NICE. Health Economics, Policy and Law
  20072(2)209-216