Gail Wilensky
|
A group of health plans, health-services researchers, drug companies, and others are asking Congress for a new agency with
major funding for research on what works best in drugs, devices, biologicals, and procedures. This is in lieu of current research
that looks simply at whether or not technologies are effective. A "center for comparative clinical effectiveness" is proposed
for improving health care as well as containing costs in a rational way. Representatives at a recent forum in Washington,
D.C., sponsored by Health Industry Forum, Kaiser Permanente, and America's Health Insurance Plans, said there is interest
in Congress in discussing such an entity, perhaps even during this session, although they would not name any potential Congressional
sponsors.
"We need to find ways to spend smarter," said Gail Wilensky, Ph.D., a senior fellow at Project Hope and a former administrator
of the Health Care Financing Administration (now the Centers for Medicare & Medicaid Services, or CMS). She has been a proponent
of this research for some time. Such a center, she said, would not be one where decisions are made but would instead "provide
data so that good decision-making can occur."
John Rowe, M.D., who until last year was CEO at Aetna, said, "I would expect wide adoption of any recommendations that came
out of an organization like this in the commercial and the not-for-profit health plans in the United States.... They are really
hungry for this."
Karen Ignagni, CEO of America's Health Insurance Plans (AHIP), said there has been much discussion about healthcare quality
and maximizing healthcare value. But, she said, "for approximately a decade or longer, there really has not been much discussion
about access to information, how we prioritize it, how we compare it, or how we analyze it." Companies providing drugs and devices should embrace this kind of research, said Kathleen Buto, M.P.A., VP of Johnson & Johnson,
because it will "cause more research to be directed, we think, to those things that matter—and, by the way, to have the evidence
produced at an early stage that appropriately looks at the value-added of these technologies." Referencing the current rate
of healthcare cost increases, which the speakers agreed is almost unsustainable, she said that having information on what
works best will be better than undertaking "draconian" measures like across-the-board cuts and "even direct negotiation with
pharmaceutical companies."
Most of the current information about safety and efficacy, Wilensky emphasized, comes from the approval process for drugs
and devices at the Food & Drug Administration. But the problem with that research, she posited, is that it is either "against
placebos or whatever the single standard of care is." More significantly, she added, that information is only on pharmaceuticals
and devices. Although she would include those things in the new research center, she said, "the money is much more in medical
procedures."
Where such an agency should be placed is still under discussion. Wilensky said that decision will be made in the political
process. It could be part of the Department of Health & Human Services, it could be a freestanding agency like the Federal
Reserve Board, or it could be an independent agency related to the government, like the Institute of Medicine.
Rowe, however, pointed to other evaluative centers that have disappeared from the federal constellation in past decades. Many
people in the healthcare industry feel the center should be completely outside government.
There are concerns within the device and pharmaceutical industries that such a center will become yet another hurdle, along
with the FDA, for products to clear. Buto maintained that guidelines based on the research should include flexibility for
the differences among individual patients.
Asked why the center should not do comparative effectiveness research on drugs before they come to market, Rowe indicated
that it was a bad idea, since a variety of drugs for the same condition can be useful because of differences in patients.
While there is also a need for cost-effectiveness research, Wilensky believes it should not be connected to the comparative
effectiveness center, for fear that political implications would kill the nascent effort.
The researchers and others also presented the ideas in a one-day meeting, last fall, sponsored by Merck, Kaiser Permanente,
and AHIP in connection with Brandeis University's "Health Industry Forum." There are also Web-exclusive papers on it in the
journal Health Affairs.
THE AUTHOR is a writer based in the Washington, D.C., area.
Drug Topics archives are now available on ModernMedicine.com, a new online resource designed to meet the evolving needs of physicians.