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Reflections on the Quality of the QALY…
Diana Brixner PhD, 2007-2008 ISPOR President and Associate Professor and Chair of
the Department of Pharmacotherapy and Executive Director of the Pharmacotherapy
Outcomes Research Center at the University of Utah College of Pharmacy, Salt Lake
City, UT, USA
Recently, I had the privilege of attending the
ISPOR Invitational Workshop on Moving the
QALY Forward held in Philadelphia, Pennsylvania
USA, November 7-8, 2007. The intent of the program
was to develop a thought-leader-driven
research agenda concerning the quality-adjusted
life-year. In the presence of those who have
originated and refined the concept of quality-oflife
as an outcome measure and those who have
debated its relevance and use in decision making
I attended as an observer, someone who has
been in the arena of conducting outcomes
research but would not consider myself either a
methodologist in the principles of the QALY nor a
direct decision maker. With these qualifiers at
hand, I made the following observations.
First and foremost is the humble recognition of
the depth and breadth of economic theory that
has gone into the development of the QALY as a
measure of patient preference for various states
of health. Competing technologies may be
assessed for their ability to either delay or prevent
transition to a less advantageous health
state in the progression of disease. Typically the
manufacturer of a technology, with demonstrated
evidence through clinical or observational studies
of such a benefit, will charge a higher price for
the product. Those in the field of technology
assessment will review the evidence and determine
a dollar value from the perspective of the
decision or policy maker on the incremental benefit
of a prolonged existence in a more desirable
health state and thus a cost per QALY is determined.
Although relatively straight forward in
principle there are challenges in the pragmatic
application of the QALY in the decision making
process. The first such issue arises when one
looks “under the hood” of how the QALY is determined.
Again, thanks to the numerous qualified
researchers in the field, the dynamics of patient
choice in good health vs. disease and in selfinterest
vs. those of an unrelated group may differ
and various techniques and tools in the measurement
of the QALY have arisen to address these
concerns. This has left the technology developers
with good intent of including QALYs as a clinical
trail measure for a technology in a quandary
as to which instruments to pick to best reflect the
benefit of their product. Current options for a
general instrument alone include the QOL Shortterm
36 or 12 or 6, the HUI1 or HUI2, VAS and
the EQ5D to measure the determinants of quality
of life before and after exposure to a treatment.
The value of the different states can be determined
by a standard gamble, time trade off, or
various other methods. The financial impact of
measuring QALY in a clinical trial cannot be
avoided. There is the cost of incorporating any
one tool into the clinical trial protocol, where the
addition of one measure can add up to a million
dollars to the budget. In addition there is the
opportunity cost related to increase in time to
collect and analyze the QALY results which may
delay approval in major markets and postpone
sales. Therefore
the complexity of
QALY analysis,
resulting in various
tools to customize
the approach, can
be a barrier in
moving the field
forward.
A second observation is in the application of
QALY information to decision making. Around
the world there are demonstrations of where the
information is being used proactively and examples
where the definition of QALY is still not clear.
In the UK, a country with a single payer health
system and a clear societal perspective in technology
assessment, the QALY seems particularly
well utilized in decision making. This has been
demonstrated by the health economist experts
that participate on the National Institute for
Clinical Excellence review board for the National
Health Service. The cost and benefit of a technology
is summarized in a cost per QALY and
standards have been set to create a threshold
(generally £30,000 per QALY) of what is acceptable
to society. On the other hand we have significant
issue in the United State in understanding
and implementing the QALY. Due to a fractured
health care system, the payers often have different
perspectives in making health care decisions,
and these perspectives may or may not include
the concept of quality of life. For many payers
the QALY has not yet been accepted as an outcome
measure, i.e. a measure of utility in a cost-utility analysis in the same way one
considers a change in blood pressure,
A1C or LDLs as an effectiveness measure
in a cost-effectiveness analysis. The connection
of a benefit in QALY to the long
term benefit in disease outcomes has
largely not been made for most US payers.
There are pockets of change from the
perspective of the employer, where a connection
between the QALY and employee
productivity is clearer, and perhaps in the
integrated health care system where all
costs are accounted for. This would
appear to be highly relevant to a single
payer such as Medicare; however the drug
benefit for the elderly is delivered through
the fragmented private payer.
In conclusion, I applaud the initiative to
bring researchers, decision makers, and
observers together to contribute to an
ongoing dialogue of how to resolve current
barriers to the acceptance of the QALY as
a measure of patient benefit, the assignment
of a cost to that benefit, and the
application of this evidence to improved
decisions in the future.
For further details on this ISPOR invitational
(funded by a grant from US Agency for
Health Care Research and Quality) workshop,
see: http://www.ispor.org/meetings/MeetingsInvited.aspx.
For QALY issues, see:
https://www.ispor.org/news/articles/Oct07/WTQ.asp.
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