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Technology coverage decision
making: further reflections from
‘an Englishman abroad’
Stirling Bryan, PhD
Stanford University
University of Birmingham, UK
Overview
• Study rationale and objectives
• Methods
• Technology coverage decision making
in the US
• Cost and cost-effectiveness in the US
• Challenges for:
• the US
• the UK
Study rationale
• High and rising cost of health care
• A near universal problem
• A major cause: ongoing introduction of new
health care technologies
• Literature
• In the US, cost-effectiveness information is not
routinely considered in coverage decisions
• In England & Wales, use of CEA at the national
level (by National Institute for Health & Clinical
Excellence)
Fellowship objectives
•
To describe technology coverage policy in
a number of US health care organizations
•
To elicit views of stakeholders on coverage
policy and, specifically, on the use of costeffectiveness information
•
To recommend how coverage policy in the
UK and US might be strengthened
New Yorker
You can rest assured, Mrs. Wilson, that your husband
will receive the best care known to medical coverage.
Methods / Data
• What am I drawing on?
• Data from 4 US case studies
Kaiser-Permanente, Aetna, Blue Cross Blue Shield,
Veterans Health Administration
• Methodology
• Predominantly qualitative
• Primarily exploratory in nature
• Data collection
• Documentary analysis
• Interviews with key professionals (n=16)
• (Workshops and surveys)
Technology coverage process
Horizon scanning
Technology
assessment
Appraisal /
Decision making
Implementation
Review /
Re-evaluation
Technology coverage process
Horizon scanning
1. Technology
assessment
2. Appraisal /
Decision making
3. Implementation
Review /
Re-evaluation
1. Technology assessment in the US
• Formal, evidence-based, policy
processes (in all settings)
• Structured and organization-wide input
to policy process (in some settings)
Structured and organization-wide input to
policy process
[the draft monograph] “goes to the VISN
formulary leaders, who review it and
circulate this to people who they think it
would be of interest to … a cardiology drug,
they send to various cardiologists. We also
broadly disseminate these monographs and
so there are technical advisory groups in the
VA, such as nephrology, etc. … and we send
a copy to them.”
1. Technology assessment in the US
• Formal, evidence-based, policy
processes (in all settings)
• Structured and organization-wide input
to policy process (in some settings)
• Focus on effectiveness (and not costs)
Focus on effectiveness (and not costs)
“That’s important – cost is not discussed. The
physicians involved, the literature, nothing
discusses cost. It’s only ‘Is it medically necessary,
is it safe and is it effective? … occasionally people
will try and get a cost discussion going but we have
to shut them down because I don’t want anybody
saying your medical policy decided this on the basis
of cost.”
“We spend a lot of time looking at costs because it’s
very important that we are good stewards of federal
tax money … and, as you know, most commonly we
don’t have good CEA data.”
1. Technology assessment in the US
• Formal, evidence-based, policy processes (in
all settings)
• Structured and organization-wide input to
policy process (in some settings)
• Focus on effectiveness (and not costs)
• Use of published material predominantly
• Limited input from industry/pharma (in most
settings)
Technology coverage process
Horizon scanning
1. Technology
assessment
2. Appraisal /
Decision making
3. Implementation
Review /
Re-evaluation
2. Appraisal / Decision making
• Decisions by formal committees (e.g.
INTC, MAP, CPC)
• Some committees do not make
‘coverage’ decisions
Some committees do not make
‘coverage’ decisions
“The Blue Cross Blue Shield companies …
make independent coverage decisions, the
Association does not make coverage
decisions for them; we make
recommendations to them on policies. Most
of the time their policies are consistent with
the recommendations in our medical policy
reference manual”
“The INTC does not make coverage
decisions. They issue advice and guidance
to the 8 regions ... Coverage decisions are
made at the bedside or on an individual
patient level.”
2. Appraisal / Decision making
• Decisions by formal committee (e.g.
INTC, MAP, CPC)
• Some committees do not make
‘coverage’ decisions
• Explicit criteria used (in most cases)
• Cost rarely considered explicitly at the
coverage decision
Technology coverage process
Horizon scanning
1. Technology
assessment
2. Appraisal /
Decision making
3. Implementation
Review /
Re-evaluation
3. Implementation
• Generally, high levels of adherence to
formulary / guidance
• Achieved through:
• Broad consultation process in policy
development
Broad consultation process in policy
development
“we spend a lot of time up front getting buy-in and
we believe that’s important … We believe that by
including them up front and giving them the
opportunity, by the time we make the decision and
they have some action, there’s not going to be as
much push-back ... So it works very well.”
“it’s not like we’re trying to reach out and grab
people by the scruff of the neck and shake them like
the health plans have to do … I don’t mean we
never have any problems but, if you sat in on the
twelve medical directors meetings during the year,
you wouldn’t hear this issue [implementation
problems] come up once at this time… not a big
deal.”
3. Implementation
• Generally high levels of adherence to
formulary / guidance
• Achieved through:
• Broad consultation process in policy
development
• Use of electronic guidelines
• Influence
• Payment
• Monitoring and feedback
Cost / CEA and US health care
• Cost considerations largely absent from
coverage decisions
• Some exceptions:
• VHA (as referred to earlier)
• Kaiser-Permanente
“CEA tends to be used more in terms of making
decisions about selection of drugs within a therapeutic
class or for a specific indication”
• BCBS
“In a number of situations we have commissioned CE
studies … as a means of providing information to the
system. Whether individual plans use those in their
decision making or not is uncertain.”
Views on cost information and CEA (1)
• Widespread (but not universal) frustration at lack of
use
“People don’t like to put a money value on life and
it’s dumb. I’ve had these discussions, … and every
time I get into this issue of cost, people say ‘Cost
should not be your concern, your concern as a
physician … should be only one thing, what is the
best thing for the patient?’ …
And I have patients who will say to me ‘Ah, the VA
is just trying to save money’ and I’m unapologetic. I
say, what is so bad about that? If money were no
issue, if the well springs were open and we had
unlimited dollars, I would love not to worry about
money.”
Views on cost information and CEA (2)
• Fear of media reaction
“Personally I would support that. From the organisation
perspective, they are so much afraid of being accused of
deciding coverage on price that they don’t want to do that
unless somebody like Medicare does it first. They don’t
want to take the heat because we would end up in the New
York Times”
• Some fear of courts
“we fear the media much more than we do the legal
because we get sued 4,500 times a year and most of them
are civil suits and we fight them and they’re all done and
don’t get in the papers”
“The hands of providers in the US are tied, especially
because of the litigious nature of the US society.”
New Yorker
And, in our continuing effort to minimize
surgical costs, I’ll be hitting you over the head
and tearing you open with my bare hands.
Views on cost information and CEA (2)
• Fear of media reaction
“Personally I would support that. From the organisation
perspective, they are so much afraid of being accused of
deciding coverage on price that they don’t want to do that
unless somebody like Medicare does it first. They don’t
want to take the heat because we would end up in the New
York Times”
• Some fear of courts
“we fear the media much more than we do the legal
because we get sued 4,500 times a year and most of them
are civil suits and we fight them and they’re all done and
don’t get in the papers”
“The hands of providers in the US are tied, especially
because of the litigious nature of the US society.”
New Yorker
I don’t feel quite as fulfilled
when I’ve saved a lawyer.
Views on cost information and CEA (3)
• Mistrust of industry-sponsored CEAs
“the problem is, as I’m sure you know working with NICE,
that usually when a new drug comes out there is no cost
effectiveness stuff, or the only stuff out there is basically
garbage from the drug manufacturer”
• Lack of relevant CEAs (e.g. analyses for VA
population)
“we don’t have good CEA models. The ones that we’ve
looked at are either too rigid, you can’t change the
parameters, … or maybe have some basic underlying
assumptions which we would not necessarily agree with and
that’s the foundation for the model … We don’t have the
funding to do a CEA for every drug”
Views on cost information and CEA (4)
• Perceived public resistance
• Problems with state regulators
• Preferable alternatives
Some of the challenges for the US
• Bolder health plans?!
• Why not test the market with policies that have explicit
limits/restrictions (‘prudent plans’)?
• Would need to overcome multiple fears: media reaction,
public backlash, litigation, regulators, not following
Medicare
• Would need strong sales pitch and strong
supporters/advocates
• Less duplication of technology assessment activity
• More collaboration, including international collaboration?
• More consideration of role/influence of
pharmaceutical and device manufacturers (some
examples of considerable success)
Some of the lessons/challenges for the
UK
• Structured and organization-wide input to
policy process
• Practice/utilization monitoring
• Policy implementation
• Appropriate role/influence of pharmaceutical
and device manufacturers
• Building ‘resource stewardship’ culture
A very big ‘thank you’ to …
• My mentors, Alan Garber and Marthe
Gold
• And everyone else at, or associated
with, Stanford
• And everyone who was happy to talk
with me
• And, not least, the Commonwealth
Fund for sponsorship!