#PharmEconFriday: Got CER?
A guest post by Brian Ung, PharmD Candidate 2016.
As part of the American Recovery and Reinvestment Act of 2009 (ARRA) also known as the Stimulus or Recovery Act, Barack Obama passed legislation that allotted $1.1 billion in government funding towards something called comparative effectiveness research (CER).1 But what is CER? And why does it need over a billion dollars?
What is CER?
The Institute of Medicine (IOM), now called the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine, has defined CER as:2
“CER is 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 to make informed decisions that will improve health care at both the individual and population levels.”
In other words: Rather than answering questions like “Does this work?” CER studies seek to answer questions such as “Is this better than that?”
How do we do CER?
CER will compare outcomes (harms/benefits) of least two alternative interventions. This information is used to address specific clinical decisions from the patient perspective or health policy decisions from the population perspective. Because comparative effectiveness research studies can be conducted in a number of different ways, it is important to understand that inherent bias and confounding associated with each methodology. The information gathered from sources to generate retrospective studies can affect the reliability of the study findings.
|Method of CER3||Examples|
|Experimental study||Randomized control trials (RCTs), head-to-head study|
|Observational study||Prospective/retrospective observational, cross-sectional study|
|Research synthesis||Systematic review, meta-analysis|
When deciding which intervention (drug, PCI, CABG surgery) to use for coronary revascularization in patients with coronary artery disease, retrospective observational studies could be constructed to compare one or more therapies against one another, evaluating which intervention was most appropriate for specific patients and sub-groups. CER studies could examine different drug therapies or pit a specified drug therapy versus a surgical intervention. Researchers could elect to use different data sources (i.e. pharmacy claims, patient charts, medical claims) to answer their questions surrounding the differences in coronary revascularization therapies.
For the full 2007 report with the example of coronary artery disease, use this link: “Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Grafting for Coronary Artery Disease.” The report contains comparisons of PCI vs. CABG surgery by various patient demographics and comorbidities. It can get complicated quickly, but this is an example to demonstrate how this research doesn’t just look at PCI vs. nothing and CABG vs. nothing.
Who conducts CER? (The Alphabet Soup of Agencies)
A combination of federal, Agency for Healthcare Research and Quality (AHRQ) and non-federal, Institute for Clinical and Economic Review (ICER) and Patient-Centered Outcomes Research Institute (PCORI) agencies have taken leadership initiatives in CER. Additionally, the Academy of Managed Care Pharmacy (AMCP), National Pharmaceutical Council (NPC), and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) have teamed up to form the CER Collaborative, which offers a Comparative Effectiveness Research Certificate to pharmacists, physicians and other clinical decision-makers and provides formal training on how to collect and assess a body of evidence generated from a number of different sources.3
- American Recovery and Reinvestment Act of 2009 (Public Law No. 111-5). February 17, 2009.
- Sox, Harold C., and Sheldon Greenfield. “Comparative effectiveness research: a report from the Institute of Medicine.” Annals of Internal Medicine 151.3 (2009): 203-205.
- Ratner, Robert, et al. “Initial national priorities for comparative effectiveness research.” Institute of Medicine. Washington, DC: National Academies Pr (2009).