A comparison of technology coverage decisions in the US and the UK: seeing the NICE side of cost- effectiveness analysis Stirling Bryan, PhD Harkness Fellow

A comparison of technology coverage A comparison of technology coverage decisions in the US and the UK:decisions in the US and the UK:

seeing the NICE side of cost-seeing the NICE side of cost-effectiveness analysiseffectiveness analysis

Stirling Bryan, PhDStirling Bryan, PhD

Harkness Fellow in Health Care Policy 2005/6Harkness Fellow in Health Care Policy 2005/6

Visiting Faculty, Center for Health Policy, StanfordVisiting Faculty, Center for Health Policy, Stanford

Professor of Health Economics, Birmingham, UKProfessor of Health Economics, Birmingham, UK

OverviewOverview

The technology coverage issueThe technology coverage issue

The UK position and the National Institute for Health & The UK position and the National Institute for Health & Clinical Excellence (NICE)Clinical Excellence (NICE)

Some research findings on the use of cost-effectiveness Some research findings on the use of cost-effectiveness analysis (CEA) in coverage decisions in the UKanalysis (CEA) in coverage decisions in the UK

My understanding of the US position (or my My understanding of the US position (or my misconceptions after 2 days!)misconceptions after 2 days!)

Some research questions (for my Harkness project)Some research questions (for my Harkness project)

Technology coverageTechnology coverage

What is it?What is it?– a decision not to ‘cover’ a technology indicates that its a decision not to ‘cover’ a technology indicates that its

cost will not be reimbursed as part of the insurance cost will not be reimbursed as part of the insurance packagepackage

– it involves setting limits on the health care services that it involves setting limits on the health care services that can be accessed or providedcan be accessed or provided

Who makes coverage decisions?Who makes coverage decisions?– private health plans and government health insurance private health plans and government health insurance

programs both make coverage decisionsprograms both make coverage decisions

Coverage decisions in the UKCoverage decisions in the UK

Local level – wide variety of primary and Local level – wide variety of primary and secondary care decision-making bodiessecondary care decision-making bodies

National level – National Institute for Health & National level – National Institute for Health & Clinical Excellence (NICE)Clinical Excellence (NICE)

– one of its functions is to appraise new and existing one of its functions is to appraise new and existing health technologieshealth technologies

– coverage decisions based on explicit criteria and are coverage decisions based on explicit criteria and are informed by an independent assessment of evidence, informed by an independent assessment of evidence, including an economic evaluationincluding an economic evaluation

– submissions also received from the sponsor of the submissions also received from the sponsor of the technology, and other expert bodiestechnology, and other expert bodies

NICE Appraisals Committee

Industry submissions

National guidance

Review and economic analysis

Horizon Scanning Long-list of technologies

Academic HTA team

Short-listof topics

Prioritisation

Patient & professional input

Examples of guidanceExamples of guidance

““Donepezil, rivastigmine and galantamine Donepezil, rivastigmine and galantamine are not recommended for use in the are not recommended for use in the treatment of mild to moderate Alzheimer’s treatment of mild to moderate Alzheimer’s disease (AD).”disease (AD).”

““Riluzole is recommended for the treatment Riluzole is recommended for the treatment of individuals with the amyotrophic lateral of individuals with the amyotrophic lateral sclerosis (ALS) form of Motor Neurone sclerosis (ALS) form of Motor Neurone Disease (MND).”Disease (MND).”

NICE Appraisal Committee NICE Appraisal Committee membership (n=28)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 … The drug itself has no side effects … but the number of health economists needed to but the number of health economists needed to prove its value may cause dizziness and nauseaprove its value may cause dizziness and nausea

UK-based researchUK-based research

Research questionsResearch questions

– To what extent, and in what ways, is cost-To what extent, and in what ways, is cost-effectiveness information used in coverage effectiveness information used in coverage decision-making in the UK?decision-making in the UK?

– How might the impact of CEAs be increased, How might the impact of CEAs be increased, particularly in relation to issues of accessibility particularly in relation to issues of accessibility and acceptability?and acceptability?

Research methods: NICE case studyResearch methods: NICE case study

Background interviews with members of NICE Background interviews with members of NICE appraisals teamappraisals team

Focus on 7 technology appraisalsFocus on 7 technology appraisals– Documentary analysisDocumentary analysis– Observation of committee meetingsObservation of committee meetings– Interviews with selected members of CommitteeInterviews with selected members of Committee

Additional, non-technology specific interviews with Additional, non-technology specific interviews with Committee membersCommittee members

The AC interview sample (n=28)The AC interview sample (n=28)

Area of expertise Number of Committee members interviewed

Medical (e.g. GP, physician, surgeon)

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 The ‘importance’ of the economic analysiseconomic analysis

People have come to accept that the economic People have come to accept that the economic evaluation is more crucial than they thought. I evaluation is more crucial than they thought. I think a lot of them came along two years ago think a lot of them came along two years ago with the idea that … you had to listen to the with the idea that … you had to listen to the economist say something. economist say something.

… … they’ve moved to saying ‘this is all so they’ve moved to saying ‘this is all so complicated, just tell us what the ICER is!’ complicated, just tell us what the ICER is!’ because they’ve actually realised that it is a because they’ve actually realised that it is a crucial issue.crucial issue.

Informationprocessing

The ‘workings’ of the Committee

Practical issuesrelating to economic

analyses

Appraisal Committee composition

Conceptual challenges

Committeeprocedures

Political

Concepts & processes

Practical

QALYsEquity

concerns

Roles ofCommittee members




analyses



Committeeprocedures

Political


Practical

QALYsEquity

concerns


Information processing (1)Information processing (1)

Ordinal approach to considering the evidence (i.e. Ordinal approach to considering the evidence (i.e. ‘effectiveness’ then ‘CE’):‘effectiveness’ then ‘CE’):

My first consideration when I look at this is ‘does this My first consideration when I look at this is ‘does this treatment actually work?’ … obviously it has to be treatment actually work?’ … obviously it has to be clinically effective in order to be cost-effectiveclinically effective in order to be cost-effective

I don’t believe effectiveness should be a criterion for I don’t believe effectiveness should be a criterion for NICE decisions. Now that’s a fundamental conceptual NICE decisions. Now that’s a fundamental conceptual problem with NICE that they require clinical effectiveness problem with NICE that they require clinical effectiveness before we go on to examine cost effectiveness. before we go on to examine cost effectiveness.

Information processing (2)Information processing (2)

NE

SW

NW

SE

Difference in cost

Difference in effectiveness

Committee proceduresCommittee procedures

The threshold:The threshold:

There is a feeling when we get beyond £30,000 per QALY There is a feeling when we get beyond £30,000 per QALY we’re running into trouble.we’re running into trouble.

I do sometimes have reservations about the figure of £30,000 I do sometimes have reservations about the figure of £30,000 per QALY. Where does the figure come from? Who per QALY. Where does the figure come from? Who determines where the cut-off point should be? … This magic determines where the cut-off point should be? … This magic figure of £30,000 keeps popping up but I lack the underlying figure of £30,000 keeps popping up but I lack the underlying knowledge to be able to challenge.knowledge to be able to challenge.

My biggest criticism … is basically we are funding things at a My biggest criticism … is basically we are funding things at a level that actually the NHS cannot fund – that the [cost per] level that actually the NHS cannot fund – that the [cost per] QALY figure is far too high, it should be much lower.QALY figure is far too high, it should be much lower.




analyses



Committeeprocedures

Political


Practical

QALYsEquity

concerns


Conceptual challenge: equityConceptual challenge: equity

No strong evidence currently on which to base equity No strong evidence currently on which to base equity weighting:weighting:

I think there’s a sort of recognition at the moment, that we I think there’s a sort of recognition at the moment, that we have no basis for doing the weighting.have no basis for doing the weighting.

Some implicit weighting is being done:Some implicit weighting is being done:

At the end of each of these discussions people say, ‘well 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 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 as a QALY regardless’. But where that isn’t true, I think, is in relation to children … although people don’t necessarily in relation to children … although people don’t necessarily explicitly state it, I think everybody tends to give it more explicitly state it, I think everybody tends to give it more weight.weight.




analyses



Committeeprocedures

Political


Practical

QALYsEquity

concerns


Practical issuesPractical issues

Understanding of the economic evaluation by Committee Understanding of the economic evaluation by Committee members:members:

Some are probably not all that clear as to how it is done … I Some are probably not all that clear as to how it is done … I think there are certainly a number who probably don’t think there are certainly a number who probably don’t understand a word of what is going on in the health understand a word of what is going on in the health economics bit. … and some people do keep very quiet economics bit. … and some people do keep very quiet when the health economics is being talked about and that’s when the health economics is being talked about and that’s very noticeable.very noticeable.

There’s a fuzzy belief that people do understand cost-There’s a fuzzy belief that people do understand cost-effectiveness, because it is so important we all understand effectiveness, because it is so important we all understand it, but the actual principles and so on are not well it, but the actual principles and so on are not well understood.understood.




analyses



Committeeprocedures

Political


Practical

QALYsEquity

concerns


The US, coverage and CEAThe US, coverage and CEA

““Coverage policy is tightly linked to the affordability Coverage policy is tightly linked to the affordability of health insurance, and hence the rate of of health insurance, and hence the rate of uninsurance … [and] also influences the types of uninsurance … [and] also influences the types of medical care Americans receive.medical care Americans receive.

Absent from these [health care reform] debates is Absent from these [health care reform] debates is any systematic discussion of processes to choose any systematic discussion of processes to choose the medical goods and services that health the medical goods and services that health insurance should cover.”insurance should cover.”

Garber (2004, p284)Garber (2004, p284)

““We currently lack a consensus on principles that We currently lack a consensus on principles that would tell us how to distribute health care fairly.”would tell us how to distribute health care fairly.”

Daniels and Sabin (2002, p3)Daniels and Sabin (2002, p3)

Medicare coverageMedicare coverage

““One of the most difficult policy issues confronted in One of the most difficult policy issues confronted in any decision on coverage criteria is the role of cost-any decision on coverage criteria is the role of cost-effectiveness analysis in deciding what is to be effectiveness analysis in deciding what is to be considered reasonable and necessary.” considered reasonable and necessary.”

Tunis (2004, p2197)Tunis (2004, p2197)

““To Medicare, CEA has been an elephant in the To Medicare, CEA has been an elephant in the living room, officially ignored despite its obvious living room, officially ignored despite its obvious importance.”importance.”

Neumann (2005, p148)Neumann (2005, p148)

A hopeful future?A hopeful future?

““After a decade of failed attempts to integrate CEA After a decade of failed attempts to integrate CEA as a criterion for coverage, prospects for its as a criterion for coverage, prospects for its ultimate adoption … appear dim.ultimate adoption … appear dim.

These attempts have revealed the strength of These attempts have revealed the strength of antagonism in the US towards openly confronting antagonism in the US towards openly confronting resource constraints. If Medicare officials – and resource constraints. If Medicare officials – and politicians – learned anything from the experience, politicians – learned anything from the experience, it was the political folly of trying to ration honestly.”it was the political folly of trying to ration honestly.”

Neumann (2005, Neumann (2005, p149)p149)

Harkness projectHarkness project Central research questionsCentral 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?

ObjectivesObjectives– In the main agencies concerned with the finance and In the main agencies concerned with the finance and

delivery of health care in the US, to describe the delivery of health care in the US, to describe the principles underlying coverage policy and the processes principles underlying coverage policy and the processes employedemployed

– For selected recent coverage decisions, to explore the For selected recent coverage decisions, to explore the ‘impact’ of using a CE criterion‘impact’ of using a CE criterion

– To elicit the views of stakeholders (including the general To elicit the views of stakeholders (including the general public) on coverage policy principles and processes, public) on coverage policy principles and processes, and specifically the use of CE criterionand specifically the use of CE criterion

Documents

A comparison of technology coverage decisions in the US and the UK: seeing the NICE side of cost- effectiveness analysis Stirling Bryan, PhD Harkness Fellow