This morning I went to a meeting on the “Do’s and Don’ts of Comparative Effectiveness Research.” Comparative Effectiveness Research, also called CER, has been the topic of much discussion since it was included in the stimulus package (American Recovery and Reinvestment Act of 2009). CER is a topic that has been discussed extensively on the ACC in Touch Blog, in part because it’s such a hot topic and in part because how it’s structured in the future could have wide-sweeping impacts on the practice of medicine.

Why so? Clearly, understanding the relative benefits and harms of two treatments is beneficial to providing the highest quality of care possible. CER has the potential to provide valuable information on the relative value of competing drugs, devices and treatment strategies, which in turn could improve outcomes, efficiency and satisfaction.

However, where the controversy comes in is how this ties into reimbursement for drugs or treatment options. If Drug A is superior for most patients than Drug B, then there is the potential that Drug B could stop being reimbursed by Medicare, which then may trickle down to private insurers. This isn’t problematic for the large majority of patients who benefit from Drug A – but what about the minority of patients who actual do better on Drug B? Should they have higher drug costs because they’re in the minority?

It’s the tie between money and effectiveness that’s at the root of the issue, and it continues to be a hot topic as evidenced from this morning’s meeting. In addition, the quality of the trials conducted – given their wide-reaching implications – is of utmost importance. The trials need to stand up to the strictest research standards to ensure that the findings are able to reflect what’s actually happening in the population.

The ACC wholeheartedly support CER for the value it will add to our cardiovascular knowledge, but recognizes the potential for it to be used to deny coverage. That’s why in 2009, the ACC released an advocacy position statement on CER, articulating where we stand on the issue. Its main findings:

• The ACC strongly supports CER as a way of having informed decision-making.
• CER priorities should be set by a multi-stakeholder group to ensure that the research agenda reflects the needs of the country. The research agenda should be based the burden of the disease being considered, mainly morbidity and mortality.
• The ACC recognizes that the research on comparative effectiveness is “only the first step in improving the quality, equity and efficiency of medical care,” and stresses that improving quality must be the primary aim of CER.
• CER should be distinct from entities that create coverage and benefit programs, and requires close monitoring to avoid adverse consequences on access, quality or safety.
• The ACC recognizes that CER will require substantial and long-term financial support.

The policy statement concludes: “The ACC believes CER research, when conducted correctly, is a useful tool that assists physicians and other providers in delivering high-quality, equitable and effective health care to patients.”

CER MUST separate cost efficiency from clinical effectiveness. Not only is this necessary to ensure coverage for all patients, it also is necessary to maintain physician and patient trust that CER is untainted scientifically from societal/government pressure to reduce costs.

Below are some related resources if you’re interested in learning more about CER, including a video on shot at one of last year’s Medical Directors Institutes. I’m interested to hear your views on CER in the comments section below.

• ACC 2009 Advocacy Position Statement: Principles for CER
• Guest blog post from former ACC Chapter President John Brush, MD, FACC on how he feel CER should be structured
• All past blog posts on comparative effectiveness

 

[youtuber youtube='http://www.youtube.com/watch?v=2EgDpoVBUjs']

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