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Strange Bedfellows
Strange Bedfellows
The Journal of Life Sciences
By Peter Pitts and Robert Goldberg
July 2,2007
The politics of healthcare make strange bedfellows. Nearly 15 years ago, most health insurance plans opposed Hillary Clinton when she tried to give American healthcare a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton plan as government takeover of medical decision-making based on cost considerations.
Last month, the presidential hopeful and the insurers stood shoulder-to-shoulder in support of giving the federal government the same power government agencies in single-payer systems have to determine what new medicines and services to pay for or not, based on what a government agency decides are cost-effective. In essence, both Clinton and the health care lobby want the government to engage in the practice of medicine.
What's changed? Clinton has always regarded government as the best arbiter of value for medicine. Health plans, now that they have a stake in Medicare, want the government to make across-the-board decisions about reimbursement. Now the Medicare Payment Advisory Commission, the independent federal body established to advise Congress on issues affecting Medicare, has endorsed a specific approach. It wants an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers and public and private payers.
The model, believe it or not, is Britain's National Institute for Clinical Excellence, which reviews comparative effectiveness of new and often expensive medicines in the way the Medicare Payment Advisory Commission and Senator Clinton envision. Steven Pearson, a senior fellow with the insurance industry lobbying group America's Health Insurance Plans, thinks that the British approach is an example of leadership and courage. As such, it's worth looking at the decision process our nation should follow in deciding how, whether and in what circumstances it will pay for a medicine.
Comparing Cost Effectiveness
The National Institute for Clinical Excellence has issued comparative 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's why policy folks in the United Kingdom instead of using the institute's acronym 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 didn't 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.
$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. America's Health Insurance Plan's Pearson has argued for the $50,000 cut-off. The Medicare Payment Advisory Commission 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 the Medicare Payment Advisory Commission, America's Health Insurance Plans and Clinton's 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 or 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 18 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 meds 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 black patients had 40 percent more deaths from stroke because they were assigned to precisely the wrong treatment for high blood pressure compared to the diuretics.
Weber particularly criticized the use of the combination of an ACE inhibitor and a beta-blocker in black patients as "absolutely inappropriate." Weber questioned how those responsible for monitoring safety in the trial could have let black 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. That should make Medicare Payment Advisory Commission, Clinton and insurers happy.
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. That explains why Clinton and the insurance lobby are allies in the effort to give government more control over these important choices in the years ahead.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner. Robert Goldberg is Vice President of Research Programs at the Center for Medicine in the Public Interest. |
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