Measure for Measure
by Elizabeth Ecker
October 2008
A proposed Health Care Comparative Effectiveness Research Institute in the United States may force the biopharmaceutical industry to emphasize patient outcomes and quality of life issues when developing a new medicinal product.
Photography by ©artpartner-images/Photographer's Choice RR/Getty Images
Legislation was proposed in the United States this summer to make a wealth of medical treatment research available to all American patients and doctors. Although there is little debate regarding the assistance that comparative effectiveness could provide to those administering and seeking treatment, the role of cost comparison in the process isn’t clear.
The Comparative Effectiveness Research Act of 2008, proposed by Senate Finance Committee Chairman Max Baucus (D-Mont.) and Budget Committee Chairman Kent Conrad (D-N.D.) on July 31, aims to improve the quality of health care for Americans through the widespread distribution and availability of medical research. In essence, it would equip Americans with sufficient information to guide their choices with regard to specific treatments and would eliminate unnecessary or excessive treatment in order to save precious health care dollars.
Distribution of this research would be facilitated through a proposed Health Care Comparative Effectiveness Research Institute—a nonprofit, non-government corporation including an expert methodology committee and peer review process to ensure the research is sound and unbiased. Through that research, the institute would be tasked with generating evidence of the effectiveness of health care interventions and services by comparing them with alternative therapies for the same conditions. This would enable doctors and patients to become informed of the best possible treatment course, not merely the one that is most common or has been used in a majority of cases.
With an eye toward expense, the proposal suggests several sources of funding for the institute including private and public funds, amounts from Medicare trust funds and fees on insured health plans. Estimates of funds after the institute’s first five years are in the realm of US$300 million annually.
Health insurers gave the proposal a resounding thumbs up in the weeks following its introduction, with BlueCross BlueShield leading the pack. In a statement released the day following the proposal, BlueCross stated that as much as 30 percent of every dollar spent on health care is currently wasted on “ineffective, inappropriate or redundant” care in the United States. The legislation, BlueCross says, “is an important and necessary first step toward creating a knowledge-based health care system where treatment decisions are based on sound clinical data.”
Physicians, similarly, sent a letter expressing support of the proposal with the American College of Physicians (ACP) commending Baucus and Conrad on the institute idea, its members and general research processes.
The ACP, however, underlined a key concern with the proposed legislation, which would have serious implications for pharmaceuticals and the overall health care community: How and when will cost-effectiveness factors come into play?
According to the proposal, “Cost and health plan design factors will not be used by the institute, but a future Congress may decide to incorporate these factors into the institute’s research down the road.” The ACP, though, strongly urges lawmakers to include cost consideration as soon as possible, stressing the importance of cost as a consideration in the evaluation of clinical intervention.
Others are more hesitant about cost coming into play, with implications for pharmaceuticals and device makers proving less enlightening. With cost consideration in early testing of treatment therapies and procedures, there is concern that costs could prohibit patients from gaining access to new and innovative treatment—that the structure of pharmaceutical pricing including research and development costs does not lend itself to a system that researches and recommends treatment based on cost. Recent examples in the United Kingdom, which relies, in part, on its National Institute for Health and Clinical Excellence (NICE) for medical technology research and assessment, demonstrate this danger for pharmaceuticals. Specifically, a draft issued by NICE in August advised against the recommendation of what the institute deemed expensive kidney cancer drugs, not because of their effectiveness, but because of their cost. Ultimately, drug companies can opt to defend the drugs in question, or lower the prices to achieve NICE’s recommendation. Similar problems could arise with a comparable research body in the United States.
To date, the U.S. legislation has not moved beyond the proposal stage. However, it remains to be seen whether potential changes to the American health care system under the next presidential term might affect comparative effectiveness research on some level. Both candidates have expressed support of the research as a tool, although not as a rigid guideline that would impact the availability of treatment for patients.
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