Pharmacy groups battle for inclusion in comparative research studies

May 8, 2009

The stimulus package passed in February has catapulted the field of comparative effectiveness research into a defining moment.

The stimulus package passed in February has catapulted the field of comparative effectiveness research (CER) into a defining moment. Meetings in Washington are packed with advocates asking that studies be formulated to emphasize one area or another. As government panels face short deadlines for setting the priorities, pharmacists are weighing in.

CER compares one intervention - drug, device, procedure, or other - directly against another. Examples include the study that found no clinically significant difference between epoetin and darbepoetin in anemia management and another study that found nonsteroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors present similar increased risk of heart attack.

For several years many advocates of healthcare quality, including leaders in Congress, have been pushing for the research to be greatly expanded, even calling for a large new government institute to direct the effort.

The stimulus funding provided a total of $1.1 billion to the Agency for Healthcare Research and Quality, the National Institutes of Health, and the Health and Human Services Office of the Secretary. Now the first plans for the work are due by midyear and the Institute of Medicine and the new Federal Coordinating Council on Comparative Effectiveness are working quickly to set priorities.

AHRQ is the thought-leader for all this, having sponsored a number of these studies in the past few years. AHRQ head Carolyn Clancy, MD, says the new funding is what has been dreamed of by agencies and people passionate about healthcare improvement.

But, she says, it is moving her agency and other parts of HHS “way, way faster” than they have been accustomed to move. Meanwhile pharmacy organizations, testifying along with many other groups, have told the agencies and committees that there are many pharmacy issues worthy of attention.

The American College of Clinical Pharmacology (ACCP) has urged that studies compare models that include the services of clinical pharmacists in interprofessional delivery of care to models that do not.

A number of models, including the Asheville project, have provided evidence of clinical pharmacists serving as part of interprofessional teams and giving pharmacotherapeutic care of high quality to patients with multiple conditions, Edwin Webb, ACCP’s associate executive director, told the IOM comparative effectiveness panel. But there are still very few of those models, he said.

At the AHRQ advisory council meeting, William Lang, MPH, vice president of the American Association of Colleges of Pharmacy, said, “We need to know which clinicians — working alone or in teams — impact those outcomes associated with medication management strategies.”

Cynthia Reilly, of the American Society of Health-System Pharmacists, called for research to compare medication therapy management delivered by pharmacists with other models of care.

Tom Clark, of the American Society of Consultant Pharmacists, said that CER should look at not only quality, but safety issues in older adults. As have manufacturers, he expressed concern to the AHRQ advisory council that comparison studies could be used to limit access to medications. Clark argued that even a drug that does not work as well as another in some studies may have a role for older adults. For example, it may have an improved safety profile or it may be able to be used for two conditions at the same time, he said.

The AHRQ council members also raised the issue of cost-effectiveness, long a hot-button topic in CER discussion. Various members told the AHRQ staff that although the agency has stayed away from those types of studies, with healthcare reform and unsustainable costs now on the nation’s agenda, it will be necessary to tackle studies looking at costs related to therapies.

A big question is whether the research will continue to focus on drugs and devices or how broadly it will begin to look at care processes. Representatives from both the pharmaceutical and medical device industries argued that the studies should look at something other than their products.

Les Paul, MD, MS, vice president of the National Pharmaceutical Council, told AHRQ that CER should not be limited just to drugs, but “should be extended to all relevant healthcare services, including medical and surgical procedures, diagnostics, and medical devices. In addition, this research should include alternative healthcare delivery methods and insurance benefit designs.”

Asked about extending CER’s subject areas and the possibility of expanding them into public health measures, AHRQ’s Clancy said there will be a lively debate in all the arenas discussing the priorities. The decisions were easier, she said, when there was only $15 million or so for CER. Now, with more resources, she said, “The question is what is more transformational, how much should we challenge the boundaries.”

But she cautioned that if the investment is seen as a success only if it fixes every single healthcare challenge, “That is a setup for failure.”