Getting Our Priorities Straight

We all are familiar with the Obama Administration’s “down payment” on healthcare reform — namely, comparative effectiveness research (CER). I’d like to define our terms and describe the priority list for CER from the Institute of Medicine (IOM). Then, I will compare and contrast this list with the “priorities” of the biologic industry.

The American Recovery and Reinvestment Act of 2009 commits more than $1.1 billion to improve the quality and efficiency of healthcare through CER. Of this, $400 million is set aside for research. Congress asked the IOM to develop a priority list of research topics that could potentially receive some of this funding.

The IOM defines CER as “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers with informed decisions that will improve healthcare at both the individual and population levels” (IOM 2009).

To compile this list, a committee representing more than 100 stakeholders considered four criteria — clinical category, study populations, categories of interventions, and research methodology. These criteria help to form what the IOM calls a balanced CER portfolio that not only studies “conditions with the greatest effects on the health of the U.S. population, but also the rare conditions that disproportionately and seriously affect subgroups of the population. The committee sees great value in extending the concept of drug-to-drug comparisons to a variety of interventions, including tests to screen for or monitor disease, surgical techniques, and therapeutic alternatives. Additionally, CER that examines different means of delivering healthcare was considered to be an important determinant of quality” (IOM 2009).

Everything, in other words, was on the table.

Ultimately, the IOM released its top 100 areas for potential funding. The first recommendation calls for the “prioritization” of CER topics that should be sustained. The IOM understands that CER is a dynamic process that will require closure of the feedback loop because disease states are complex, and knows that a CER program must be open to public analysis. Moreover, any program should promote rapid adoption of CER findings and identify the most effective strategies for disseminating them; currently, it takes nearly 17 years for good health research to make it from the bench to the bedside.

Among the top 25 recommendations for CER funding was one to “compare the effectiveness of different strategies of introducing biologics into the treatment algorithm for inflammatory diseases.” I am happy to see this, but it is the only explicit recognition of the role of biologics in the top quartile of potential CER projects. Surely, the industry could have promoted a broader biologic-based agenda.

Across all of its recommendations, the IOM wants more research into patient adherence to therapy. Additionally, the IOM calls for an opportunity to “compare the effectiveness of shared decision making and usual care on decision outcomes such as treatment choice, treatment-preference concordance, and decisional conflict in children and adults with chronic diseases such as stable angina and asthma.”

Despite the IOM’s request for broad public input, the pharmaceutical industry, including biotechs, provided only 11 of the 2,600 suggestions submitted from professional groups, policy makers, and the public (Yao 2009). If the industry sent in only 11 suggestions, it can’t be too upset with the IOM’s priorities. From a research angle, I’m happy that the Jefferson School of Population Health is working on many of the issues on the IOM list. It strikes me as the adage that you can’t expect change unless you are directly participating in the process of change itself.

How will the biologics industry relate to these priorities? Only time will tell. Perhaps, as the agenda unfolds, the biologics industry will continue to have an important role in securing clinical benefits for our ultimate customer, the patient. As always, I am interested in your views. You can e-mail me at « david.nash@jefferson.edu», and please visit our website at «http://jefferson.edu/population_health».