This content appeared in the January 2, 2012 print edition of Chain Drug Review.
In the span of just one year, the health care landscape has undergone dramatic changes. Many elements of the health reform law—the Patient Protection and Affordable Care Act--have gone into effect, and elements like comparative effectiveness research (CER) are now more widely understood by policy makers as potential tools to improve patient health outcomes.
Included in this vast new landscape is the creation of the Patient-Centered Outcomes Research Institute (PCORI), the public-private entity charged with overseeing CER. PCORI is now fully operational and is developing an agenda and national priorities that will establish CER as an integral part of our evaluation of quality and outcomes in our health care system.
Potential of CER
But most important, the notion of what CER can and should be used for is evolving, and for the better. Back in 2009, President Obama was quoted as defining CER as comparing the “blue pill versus the red pill,” and explained that if they worked equally well but one cost less, then the lower priced pill should be utilized. What the public is now beginning to understand two years later, and as pharmacists know well, is that no pill works equally for all people. Some respond to one treatment while others respond to another. Even within specific patient populations, individual patients will have varied preferences around what matters most to them. If CER is used to determine what works best on average, we may lose sight of what works best for individuals. If coverage and/or reimbursement decisions are made based on the average, then individual patient health outcomes may not improve (they may decline) and costs may actually go up. While this issue of treatment variations, known as heterogeneity, has not fully been resolved, it is now an important part of the CER and health care conversation.
Discussion of the Results
Another major development in the CER dialogue is the realization that our current rules and regulations may not allow for a full and accurate discussion of CER results. Currently innovative pharmaceutical companies are strictly regulated by the Food and Drug Administration in what and to whom they can communicate when it comes to their products. However, these rules do not take into account the new world of CER. Since it is clear that pharmaceutical products will be part of CER research, who will be able to discuss the results, just the researchers or sponsoring organization? How will pharmaceutical companies be able to respond to research conducted on their own products? What role will stakeholders like pharmacists have in this discussion, since contradictory results may be produced from multiple studies? We must address this issue, or in the end we may ill-serve patients and the physicians who treat them.
Related to the debate over CER communications is the issue of academic detailing. CER will be further amplified through academic detailing initiatives, in which government or academic institutions train health experts to discuss CER with physicians. In the United States, the Agency for Healthcare Research and Quality is leading the multi-million dollar federal initiative that is targeting primary care physicians and health systems. The federal government is not alone in its efforts – states including Vermont, Pennsylvania, South Carolina and Maine have been conducting academic detailing for a number of years.
Additionally, CER information will be further disseminated via continuing medical education programs and payer review guides, which are currently in development by groups such as Prime Education Inc. and the University of Arizona.
Although these programs can be useful in providing providers and payers with information that they might not have been aware of, some health care stakeholders have expressed concern that the information could be incomplete, inaccurate or misleading unless there are rigorous checks and balances in place to ensure accuracy. This is especially important because health care providers need the best and most reliable information available so they can make treatment decisions that are in the best interests of their patients.
Employers Take Interest
Another significant change is the interest of employers in CER. Employers are looking to reduce health care costs and improve the quality of care their employees receive, because they recognize that healthier employees lead to greater productivity. As an NPC survey of employers found, employers view CER as a potential tool in meeting these objectives. So it is important to take this interest in enhancing employee productivity into consideration as we move forward with developing and publishing CER studies.
Similarly, payers also are looking to reduce costs and improve health, and CER will play a key role. Payers--including private insurance and state Medicaid programs--utilize CER in decision-making but often interpret and apply this evidence in benefit designs in very different ways. With an influx of CER expected in coming years, it will be important for payers not to view CER as a “blue pill versus red pill” exercise but to take a more sophisticated approach that will lend itself to improving outcomes as treatment becomes less one-size-fits-all and more tailored toward each individual.
Making Value the Measure
The hope is that all of this leads us to a better understanding of the importance of using value as the measure in health care. But we need to better understand that the more targeted our treatments can become, the fewer occasions there will be when ineffective or inappropriate treatments are used. This in turn will lead to better outcomes, quicker end to disease or illness, faster returns to work and increased productivity both at work and at home, and overall lower costs.
If we can get to an understanding of CER in helping us make treatment decisions based on the value of a specific treatment for an individual, CER will certainly be a valuable tool in helping the country improve health outcomes.