As a part of ‘evidence-based medicine,’ CER uses a number of methods including randomized controlled trials, observational studies, and systematic reviews, which assess and compare the results from multiple primary studies. By comparing the results of treatments, CER can help demonstrate whether one treatment option is superior for certain patients under certain circumstances or that a less expensive alternative is equally effective.
CER has been carried out in the US since the 1970s, usually by government entities. The National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), and the Department of Veterans Affairs have all conducted CER programs. In addition, CER has been used as a model in clinical ‘comparator’ trials by the life sciences industry, private payers, collaborations between public and private organizations, academic researchers, professional societies, and manufacturers.
Recently, CER has been the focus of attention – and controversy – in relation to the 2009 healthcare reform bill. No one debates the basic need for reform. The US now spends more than any other country – and more per person – on healthcare. In 2010, healthcare expenditures were estimated at $2.6 trillion, about 18 percent of the nation’s GDP. By 2019, US healthcare expenditures are estimated to increase to $4.6 trillion, approximately 20 percent of the GDP.
However, The Institute of Medicine, part of the National Academies, reports that more than half the treatments provided to patients lack clear evidence that they are effective at all. Yet research on comparative effectiveness has traditionally been limited to less than 0.1 percent of total investments in healthcare. Not surprisingly, the American Academy of Family Physicians recently stated that ‘despite the numerous randomized clinical trials’ that are conducted each year, around the world, there still is a surprisingly large gap between what we know and what we need to know to provide optimal care.
To help address these issues, the healthcare reform bill included several measures to increase support and funding for CER. The American Recovery and Reinvestment Act of 2009 (ARRA) appropriated $1.1 billion to conduct and fund CER over the next two years. The AHRQ, the NIH and the Secretary of Health and Human Services (HHS) each received funding between $300 and $400 million. The Patient-Centered Outcomes Research Institute (PCORI) was created as a provision in the healthcare law to coordinate research comparing medicines, devices or methods of delivering care for patients.
In addition, the newly established Federal Coordinating Council (FCC) for CER developed a CER priority-setting process. The Council recommended focusing federal investments on the development of a CER infrastructure and the creation of strategies to support the translation and distribution of CER findings.