Authors explain why health care reform initiative should include CER

The current health care reform bills approved by the House and the Senate seek to expand health insurance coverage while containing costs; however, the proposed policy changes are not guaranteed to improve health for individuals or society, according to a "Perspective" article by faculty of Weill Cornell Medical College in the Jan. 6 New England Journal of Medicine.

To better assure that the public's health is improved, rather than diminished, by financial and regulatory measures aimed at containing costs, the authors explain why any reform initiative should include comparative effectiveness research (CER) -- a method of comparing medical treatments, such as between two drugs or devices, to determine which works best for patients.

"Although both the House and Senate versions of the health care reform bill include provisions for funding comparative effectiveness research, unfortunately, there is still a widespread lack of understanding about what CER will do," says lead author Dr. Alvin I. Mushlin, chairman of the Department of Public Health and the Nanette Laitman Distinguished Professor of Public Health and professor of medicine at Weill Cornell Medical College, and public health physician-in-chief at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

"Many people fear that patients will be denied effective care on the basis of CER's findings. In fact, CER is a tool that will lead to more effective care. One way will be by preventing insurance companies from blindly denying coverage for treatments that are more expensive but produce the best outcomes for certain categories of patients," says Dr. Mushlin.

One example is implantable defibrillators for patients with tachycardia following a heart attack. While initially more expensive, the treatment has been shown to be more effective than drug therapy in terms of improving outcomes and quality of life for patients over the long term.

Likewise, CER can identify less-expensive therapies that produce better outcomes. For example, inexpensive diuretic medications have been demonstrated to be more effective than more-expensive treatments such as angiotensin-converting enzyme (ACE) inhibitors, calcium-channel blockers, and alpha-blockers.

These changes in care and outcomes, the authors argue, would never have been envisioned, much less achieved, through shifts in the financing, organization or delivery of care.

"In this era of high-tech care, it's unlikely that less-complex and cheaper therapies will be utilized unless CER is allowed to identify and validate them," says Dr. Hassan Ghomrawi, instructor in public health in the Division of Health Policy and the article's co-author. "We need such research to suggest ways in which the proposed new financial incentives can be applied effectively and safely."

Creating Disincentives for "Me Too" Drugs and Devices
In addition to having direct effects on clinical decisions, the authors write that CER should also improve medicine in other ways. One way is changing the climate so that health care decision makers favor data from CER that will create disincentives for the development of "me too" drugs and devices that offer the same benefits as existing therapies without lowering the cost. And once the medical community begins to expect and demand clear evidence of superiority, pharmaceutical companies and device manufacturers will have to devote more of their resources to the discovery of true advances.

Furthermore, if the emphasis is also on cost reduction, there is an added incentive to do the research and development that will bring to the marketplace not only superior therapeutics, but equivalent interventions that are cheaper than their predecessors and therefore more cost-effective. Such comparative effectiveness and cost-effectiveness requirements have already led to the development and introduction of superior drugs in Britain, Australia and Canada.

Finally, CER will help the academic medical and public health communities to develop a research agenda that will provide health care professionals with information for clinical decision making. At the same time, the push for CER will result in greater demand and thus more opportunities for physician-scientists to do this type of research.

"The medical and public health communities should be enthusiastic about CER and support it. It is physicians' first line of defense against blind cost containment. On the basis of CER, our drug and device industries will be encouraged to produce products that really matter," says Dr. Mushlin. "Important medical decisions should be guided by the scientific community, not the capricious nature of the marketplace."