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:
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
- 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.”
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.