Comparative effectiveness research is the big buzzword these days. I can’t turn my head 360 degrees without having heard the word thrown at me at least three or four times. The newly fanned health care reform debate, along with the perennial search for a panacea for outcome measurements, is no doubt fueling the demand for tools such as CER. In my opinion though, the debate over the use of CER is not the real issue here. The real issue is how far we can take a tool like CER and how much benefit we can derive from it.
CER has not been widely applied in studies assessing the value of therapeutics, unlike in other market segments, including life sciences and pharma manufacturing, where it’s commonplace. There’s likely many reasons for this, not least of which is the relative lack of controls that regulators put on some health care operations. For example, opening a lab requires CLEA certification, but that process is nowhere as complex and drawn-out as the clinical trial requirements for a new drug launch, which leads to the necessity of leveraging comparative effectiveness and other existing research studies to shorten the trial time.
The other reason could be the fact that establishing a common consensus for the best practices for a therapeutic process is a task much easier said than done. Have you ever tried to convince two doctors on one point of view?
Even now the industry seems to view CER simply as a way to promote “value-based purchasing,” rather than a tool that has the ability to make a sea change in the arena of clinical pathway management.
In the provider setting, CER outcomes based on the analysis of controlled clinical trials, patient registries, observational studies, and claims records can hugely contribute toward clear-cut treatment decision support. CER also provides rapid identification and dissemination of disease-specific standards of clinical practices, prioritization of therapies based on drug-drug interactions and patient medical profiles, and identification of high-risk patients for triaging and prompt intervention.
Not only that, but historically, provider organizations have largely relied upon physician/surgeon preferences as the primary factor in deciding whether to utilize any new drug or device (irrespective of cost and clinical outcomes). CER could potentially be the decisive tool that enables executives to fight vigorously against this traditional approach, and set a new direction for inclusion of head-to-head cost and/or cost-to-outcomes comparisons to guide their purchasing decisions.
There might seem to be much less impetus for health plans to utilize comparative effectiveness research. But in my opinion, payers too have a list of benefits to derive from it. Upfront, CER can help build an accepted framework for the evaluation of cost-effectiveness and clinical benefits of new pharmaceutical products and medical devices so as to fine-tune the medical policies and coverage decisions of their members. But that’s not necessarily the limit for CER use in the payer space. Obviously, payers can also leverage this powerful analytical tool to rationalize their utilization reviews, premium pricing, provider credentialing, quality monitoring, and medical management programs to derive the best business outcomes.
Also, even with all the worries besetting pharmaceutical companies and device manufacturers (e.g., cheap, off-patent drug versions overtaking the market, obsolete devices providing imperceptible treatment benefits) CER offers a set of unique opportunities for them to take the lead in establishing a value-based system for their products that will compensate innovation fairly by building and extending the value-based purchasing concept.
All these advantages may be perceived differently by clinicians. To them it may seem like CER is a tool to curtail their autonomy in making clinical judgments. But I feel strongly that if CER is used judiciously, it will consistently inject the value of scientific investigation into the nation’s health care by delivering the right treatment to the right patient at the right time. As our esteemed founder is so fond of saying, “In God we trust, everybody else brings data.” A scientific, data-driven tool can whittle away at the subjectivity embedded in so decision making processes, and over a period of time, the regressive nature of such analysis will unearth the best results. If I may take the liberty to paraphrase the words of a very smart person from recent history, I would say “survival of the fittest therapeutic pathway.”
Rajiv Sabharwal is the chief solution architect in the Healthcare and Life Sciences unit at Infosys Technologies LTD. He can be reached at Rajiv_Sabharwal01@infosys.com.
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