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Comparative Effectiveness: Government's Way To Convert Patients Into Cost Centers?
Vol. 24 No. 5 February 13, 2009
“COMPARATIVE EFFECTIVENESS”:
GOVERNMENT’S WAY TO CONVERT
PATIENTS INTO COST CENTERS?
by
Peter J. Pitts
Like other cost-based practices, comparative effectiveness (aka “healthcare technology assessment”)—the
effort to manage medical technologies by evaluating their relative value—is designed to reduce costs and restrict
patient care. But, properly designed in a way to provide and pay for the best care for patients, it can also be
patient-centric. Just as we need new and better tools for drug development, we need them for effective
measurement as well.
Today, health technology assessment is a short-term, short-sighted, politically-driven policy that results in
one-size-fits-all medicine. While it may provide transitory savings in the short-term, current strategies result in a
lower quality of care that result in higher healthcare costs over time.
Comparing Cost Effectiveness. The United Kingdom’s National Institute for Health and Clinical
Excellence (NICE) has issued cost effectiveness decisions for many new medicines. More often than not, after a
one- to three-year period of review after a drug has received market approval, the institute has recommended
against using the drugs because they are not cost effective compared to existing treatments. That is why policy
folks in the UK, instead of using “NICE” prefer “NASTY”, for “Not available, so treat yourself.”
The drugs the institute has rejected or rationed include Gleevec, a drug that targets a specific pathway that
causes stomach cancer. In 2001, Gleevec became frontline therapy for stomach cancer in the United States. To
the outrage of most cancer specialists, the institute took three years to decide that it would use Gleevec as a last
resort, in a limited dose. It took Gleevec away from patients who have some tumor sites that are responding to
treatment and some tumor sites that are not.
The institute has also recommended against paying for Herceptin to treat metastatic breast cancer, as well
as other drugs used to treat osteoporosis, Alzheimer’s and multiple sclerosis based on comparative effectiveness
reviews. Similarly, independent review agencies in Australia, New Zealand and Canada have done the same.
The institute did not regard any new drugs as clinically less effective then older drugs. Rather, officials
judged them to be, relative to their cost, not worth paying for given the additional benefit the drugs provided. The
benchmark used in each case was something called a “quality of life year” or a year of life free of disease or
infirmity.
Copyright 8 2009 Washington Legal Foundation 2 ISBN 1056 3059
Sir Michael Rawlins, chairman of NICE, told the British House of Commons that comparative
effectiveness, a means of health technology assessment, is not based on empirical research: “There is no
empirical research anywhere in the world, it is really based on the collective judgment of the health economists
we have approached across the country,” he said. “It is elusive.” See
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/uc27-i/uc2702.htm.
The problem is that health technology assessment, as it is currently designed, places into conflict the
short-term budgeting dilemmas of governments elected for relatively short periods of time with the everlengthening
life spans of their electorates.
$50,000 Per Year of Life. In every analysis described, health systems assumed an additional quality of
life year was worth about $50,000, the average price of a fully loaded Land Rover. Because most new medicines
are targeted therapies that are tested first in critically ill patients, it will be almost impossible to demonstrate
significant improvement in well-being or life expectancy for any new medication. The United States Medicare
Payment Advisory Commission (MedPAC – the independent federal body established to advise Congress on
issues affecting Medicare) never mentions a number, but invokes efficiency enough times to make the point that
comparative effectiveness is tool for controlling costs, not improving the lives of people. Indeed, it notes
“increasing the capacity to examine the comparative effectiveness of health care services,” will lead to
“[increased] federal administrative spending relative to current law.” That would mean more price controls and
government interference in medicine.
It happens that MedPAC and America’s Health Insurance Plans favor large randomized clinical trials to
compare older drugs sponsored in part by government agencies and private companies. Randomized trials tend to
ignore differences in clinical outcomes due to side effects or genetic variations. So whether you analyze them
together or individually, researchers will most always find no difference in the effect of medicines, a result that is
biased in favor of older, cheaper drugs.
Proponents point to two troubling examples. For instance, The Department of Veterans Affairs, along
with the National Institute of Mental Health, conducted a study comparing older and cheaper drugs for
schizophrenia to newer ones. Patients with chronic schizophrenia were assigned to treatment with perphenazine,
olanzapine, risperidone, quetiapine or ziprasidone for up to eighteen months.
The first thing the National Institute of Mental Health and the Department of Veterans Affairs did was
exclude people who froze up and went numb from the older drugs, a common reaction that led to the
development of second-generation medicines in the first place. Then the study only compared how well each
patient did on each drug. Even then, the researchers assigned their own value to the reasons patients switched,
substituting their preferences for those of patients and patient groups. Even though most patients wound up
staying on newer drugs for longer periods of time—because of side effects that the study devalued—the
researchers claimed that the older drugs were cost-effective.
A Judgment Controversy. Another example of the kind of research proponents of comparative
effectiveness swoon over is the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.
That was a five-year, 42,000 patient trial that studied the comparative effectiveness of first-generation blood
pressure drugs (diuretics) against second-generation medicines in reducing heart attacks. Patients were allowed to
switch to a combination of drugs only if they failed on the older medicine first.
The authors of the study concluded that diuretics were cheaper and as effective in reducing death from all
forms of heart failure, if not heart attacks and were therefore cost effective. But like the trial conclusion in the
study that compared drugs to treat schizophrenia, this judgment was not without controversy. As Michael Weber,
one of the members of the steering committee overseeing the trial noted, the entire cost benefit of the older drugs
was based on the fact that African-American patients suffering forty percent more deaths from stroke because
they were assigned to precisely the wrong treatment for high blood pressure compared to the diuretics.
Copyright 8 2009 Washington Legal Foundation 3 ISBN 1056 3059
Weber particularly criticized the use of the combination of an ACE inhibitor and a beta-blocker in
African-American patients as “absolutely inappropriate.” Weber questioned how those responsible for monitoring
safety in the trial could have let African-American patients be exposed to certain danger and even death. The
Department of Veterans Affairs now has a program where it pays doctors to prescribe blood pressure medications
according to guidelines that emerged from the trial.
As currently organized, comparative effectiveness will be used to increase government control over the
practice of medicine and expand price controls. It will turn patients into cost centers, not the center of efforts to
prevent disease and extend life. Using a combination of cutting-edge information technology and genetic tests,
doctors can do a better job than any cost-benefit agency to ensure that their patients get the right treatment at the
right time. Many new drugs, including top selling cancer drugs such as Tarceva and Avastin, have associated
genetic tests either on the market or in clinical development that will allow doctors to provide individuals with
personalized medicine. New drugs for asthma, depression, HIV and blood pressure will have similar tests.
Personalized medicine gives doctors and patients control over healthcare decisions while comparative
effectiveness, as it is now defined, will increase government control over the choices doctors and patients make
in the future. The battle over the value of medicine and who decides what is valuable will determine who controls
healthcare in America over the next decade.
In his movie SiCKO, the simplistic and calculated portrayal of how other nations provide healthcare,
Michael Moore depicted the British National Health Service and the Canadian health system as particular
exemplars of excellence. He backed it up with a lot of statistics, but statistics, as the saying goes, are like a
bathing suit. What they show you is interesting, but what they conceal is essential.
And what SiCKO concealed was that systems such as those in the United Kingdom and Canada are costbased
rather than patient-centric models. Facts, no matter how inconvenient to one’s argument, must not be
ignored.
Citizens of countries with government-run health care systems experience long wait times, a lack of
access to certain treatments and, in many instances, substandard medical care. For example:
•The five-year survival rate for early diagnosed breast cancer patients in England is just 78 percent,
compared to 98 percent in the U.S.
•A typical Canadian seeking surgical or other therapeutic treatment had to wait 18.3 weeks in 2007, an
all-time high, according to The Fraser Institute.
•The average wait time for bypass surgery in New York is 17 days compared to 72 days in the
Netherlands and 59 days in Sweden.
•More than half of the Canadian adults (56 percent) sought routine or ongoing care in 2005—of these,
one in six said they have trouble getting routine care.
•Eighty-five percent of doctors in Canada agree private insurance for health services already covered
under Medicare would result in shorter wait times.
•Approximately 875,000 Canadians are on waiting lists for medical treatment.
“Congress has an important role to play in health care reform” said United States Representative John
Shadegg, who has introduced health care legislation in support of free-market competition. “We can help patient
in this country, not by setting up a massive new government bureaucracy, but by empowering individuals to
make the best choices for themselves and their families.”
If we are going to look to other healthcare models for solutions, we must uncover and study their
problems. Healthcare is too important to allow reform by sound bite. “Drugs from Canada” is as much a false
promise as “free” healthcare.
Last autumn, the Center for Medicine in the Public Interest interviewed people on the streets of New
York City and asked them if they’d prefer “government” healthcare or “universal” healthcare. They
overwhelmingly chose “universal” healthcare. But when we asked them to explain the difference between the
two, they generally just shrugged their shoulders. See http://www.youtube.com/watch?v=CnvQt587TPY.
And when we asked them how much more in taxes they would be willing to pay to support universal
healthcare, they shook their heads and said, “No, we want it to be free, like in Europe and Canada.” Such are the
fallacies that political rhetoric hath wrought.
Equally as prevalent is the notion of “free” or “low cost” drugs “like in Canada and Europe.” And here
too we need to be honest and examine the other side of the coin – that of cost-savings for the payer (often in the
guise of healthcare technology assessment programs such as Britain’s National Institute for Health and Clinical
Excellence) versus care denied for the patient. What is overlooked is that price controls equals choice controls.
Our national conversation about healthcare has to go beyond vague concepts of reform and convenient
political rhetoric. We must all be part of the solution and suspicious about false choices.
New Model Needed. We need to develop proposals that modernize the information used in the evaluation
of the value of treatments. Just as the key scientific insights guiding the FDA Critical Path program are genetic
variations and biomedical informatics that predict and inform individual responses to treatment, we must
establish a science-based process that incorporates the knowledge and tools of personalized medicine in
reimbursement decisions: true evidence-based, patient-centric medicine.
For instance, the FDA, in cooperation with many interested parties, has developed a Critical Path
opportunities list that provides 76 concrete examples of how new scientific discoveries in fields such as genomics
and proteomics, imaging, and bioinformatics could be applied during medical product development to improve
the accuracy of the tests used to predict the safety and efficacy of investigational medical products.
We need a Critical Path for Comparative Effectiveness to begin the process of developing a similar list of
ways new discoveries and tools (such as electronic patient records) can be used to improve the predictive and
prospective nature of comparative effectiveness.
It’s a complicated proposition—but such a goal is as simple as it is essential—cost must never be allowed
to trump care, and short-term savings must not be allowed to trump long-term outcomes. Just as we need new and
better tools for drug development, so too do we need them for comparative effectiveness measurements.
A health technology assessment model for the 21st Century should reflect and measure individual
response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what
keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new healthcare
paradigm capable of providing for its needs in the 21st Century. Equality of care must be matched with quality of
care.
In an era of personalized medicine, one-size-fits-all treatments and reimbursement strategies are
dangerously outdated. We are early in this debate, but at least we can all agree that this is not, and must not be
exclusively, a debate about saving money. It must be about patient care.
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