IOM, AHRQ and the FCCCER discuss funding CER

By Dan Leonard, NPC President

In recent weeks, the Institute of Medicine (IOM), the Agency for Healthcare Research and Quality (AHRQ), and the Federal Coordinating Council for Comparative Effectiveness Research held public meetings to discuss priorities for funding comparative effectiveness research (CER) projects with the $1.1 billion allocated by the economic stimulus bill. It’s not surprising that this funding has generated considerable debate among health care stakeholders, who are concerned about how the research dollars will be prioritized and disbursed.

It is clear, however, that there is a pressing need to improve the quality of care and stem the unsustainable growth in health care costs in the United States, and CER is being positioned to help with both of those issues. With that in mind, it is reasonable for CER priorities to focus on medical conditions with the greatest impact on morbidity and cost. These include chronic conditions such as cardiovascular disease, chronic obstructive pulmonary disease, asthma, cancer, diabetes, and serious mental health conditions. CER should not be limited to the drugs used to treat those conditions, but rather, it should be extended to all relevant health care services, including medical and surgical procedures, diagnostics, medical devices and healthcare delivery methods, including benefit designs. Regardless of which conditions or services are chosen to be studied, the prioritization of CER study expenditures and the associated research time frames should be transparent to all health care stakeholders, and the study outcomes and related information must be disseminated to health care providers and patients in a timely manner.

It also is important for the IOM, AHRQ, and certainly the new Federal Coordinating Council for CER, to consider additional factors in their decision-making processes as well.

• First, they should conduct an assessment of strategies to ensure the continuous evaluation of new evidence that may be generated about specific healthcare technologies (e.g., when should a health technology assessment be revised based on new clinical information?).
• Second, they should study how best to employ CER in a manner that preserves incentives for the continuous innovation of healthcare technologies in areas of unmet need.
• Third, it should be a priority to study how CER can be balanced with the goals of personalized medicine to encourage the development of targeted therapies for subpopulations.
• Fourth, it is important to define rigorous, high quality, and validated CER methodologies that are focused on providing timely, accurate and balanced information to providers and patients in order to assist clinical decision making. Decision makers must consider, among other issues, how best to address the full range of effects of a new technology, including quality of life, functionality, and productivity, as well as how best to appropriately characterize the strengths, weaknesses, and limitations of various underlying health technology assessment analytic methodologies in the dissemination of CER.
• Fifth, there should be clear support for the development of new CER methodologies, such as analysis of non-randomized studies of treatment effects using secondary databases, practice-based clinical practice improvement studies, more accurate modeling and simulation techniques, and methodologies that ensure optimal interpretation and application of CER in a variety of patient care settings.
• Sixth, the pharmaceutical industry has considerable expertise and experience in generating scientific data and developing research methodologies. IOM, AHRQ and the FCCCER should view the industry as valuable stakeholders who can be called upon to assist with challenging CER questions.
• Lastly, when considering CER findings, decision-makers should consider a broad view of the value of healthcare technology including associated improvements in quality of life and productivity and the reduction in days missed from work, hospitalization, and caregiver burden.    

It is critical for the federal agencies to establish the right guiding principles that will be used by decision-makers in determining CER priorities, which can play a critical role in improving patient health outcomes in the future. Ultimately, it is the patients who will benefit under a healthcare system where sound evidence is recognized by independent experts, considered appropriately by plans, reflected adequately in benefit design, and incorporated into clinical decision-making.