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Medicare News
Medicare Making Decisions Based on Profiles that Do
Not Match Beneficiaries
Cardiovascular clinical trial participants differ
in age, sex and country of residence
 Jan. 30, 2008 – Despite the skyrocketing costs of
Medicare and the demand for informed decisions, Medicare is using
clinical trials with participants that do not match the characteristics
of beneficiaries to make decisions about cardiovascular products and
services. The trial participants differ in age, sex and country of
residence, according to a report in the January 28 issue of Archives of
Internal Medicine, one of the JAMA/Archives journals.
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Cardiovascular disease is the leading cause of
death and disability among Medicare beneficiaries, according to
background information in the article; expenses for this condition
exceed those for any other.
“Because Medicare expenditures continue to increase
rapidly, it is necessary that coverage decisions be based on data most
likely to maximize value and optimize outcomes for Medicare
beneficiaries,” the authors write.
An independent panel of physicians and other
professionals advises the Centers for Medicare and Medicaid Services
(CMS) on medical technologies. Panelists review technology assessments
prepared for each new medical product or service and then vote on the
quality of evidence for health benefits.
Sanket S. Dhruva, B.A., and Rita F. Redberg, M.D.,
M.Sc., of the University of California at San Francisco School of
Medicine performed a meta-analysis of all trials included in technology
assessments considered by the CMS advisory panel between 1998 and 2006.
For the panel’s six meetings, 141 studies with a total of 40,009
participants were analyzed.
Compared with Medicare beneficiaries, clinical
trial participants were -
● average age of 60.1 years vs. 74.7,
● 75.4 percent males vs. 41.8 percent and
● 60 percent lived in countries outside the United States vs. zero.
“The trials are conducted mostly in younger,
healthier, male, non–U.S. populations,” the authors write.
“Medicare beneficiaries, on the other hand, are
mostly older women with comorbid [co-occurring] conditions. The clinical
trials primarily relied on to inform national coverage decisions simply
do not reflect the Medicare patient population.
Compounding this
problem, data frequently are not reported by age, sex and race.”
Elderly people and women are the most likely to be
affected by these disparities and should be included in more clinical
trials, the authors note.
“The Food and Drug Administration already requests
sex-specific data for new drug applications; it certainly would be
consistent, and logical, for the CMS to require direct evidence of
benefit in the coverage process.
“Alternatively, the CMS could issue a coverage
decision with a requirement that continued coverage after a specified
period depends on additional subgroup data, a variation of the newly
introduced ‘coverage with evidence development’ initiative,” they write.
“Closer linkage of evidence to coverage would
promote better value and improved outcomes for the rapidly growing and
underrepresented population of Medicare beneficiaries.”
Editor's Note: This study was supported by a
University of California at San Francisco Dean’s Summer Research
Fellowship and by a Robert Wood Johnson Health Policy Fellowship.
Commentary:
Clinical trial results cannot always be generalized
The results of randomized clinical trials are most
directly applied to populations of patients similar to those who
participated in the study, write Noel S. Weiss, M.D., Dr.P.H., and
colleagues at the University of Washington, Seattle, in an accompanying
commentary.
“However, as Dhruva and Redberg illustrate in this
issue of the Archives, the demographic profile of a trial’s participants
and the medical care environment in which the trial is conducted may
differ considerably from the target population and practice context in
which the trial’s findings are later used to guide clinical decision
making and policy,” the authors write.
“Although the measured effect of a particular
therapy on a health outcome in the study population included in a given
trial will, in many instances, closely reflect the effect of that
intervention on the corresponding outcome in other settings, this
extrapolation should not be made reflexively,” they conclude.
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