04 May Why do a Study Like That?
By Ramesh Nathan, MD
I recently was invited to participate in a research study, looking at the economic impact of a new drug for the treatment of Clostridium difficile infection. The new drug, called Fidaxomicin, has been available for a few years and has proven efficacy in thousands of patients but is generally very expensive. The study will follow patients after their hospitalization and delve into analyzing the monetary costs associated with the medicine, the disease, and the lost productivity that often ensues- I was excited to participate. I mentioned the study to a colleague and he seemed puzzled. “Why do a study like that? They should be looking at clinical outcomes of the disease. That’s what really matters.”
However, I wondered, wouldn’t there be value in knowing cost information? How about co-payments for medicines? Does that have any effect in delivery of medical care? A recent study published by researchers at the University of North Carolina School of Medicine and its affiliated School of Public Health found that patients with higher co-payments were 70 percent more likely to stop taking their cancer treatment and 42 percent more likely to skip doses. The study published in the Journal of Clinical Oncology, is one of the first to examine the effect of high out-of-pocket drug costs for targeted cancer therapies on patients. Cost analyses of a particular medicine or disease state are are not new in the medical literature, but I believe these studies can have a much more prominent impact in modern medicine. Rarely are these type of studies considered a groundbreaking discovery; however, they take a highly pragmatic approach and focus on the economics of care.
Utilizing the value of care can assist clinicians in real-time decision-making, especially when there is a high cost but efficacious medicine. Cost analyses can also be instrumental in determining “low value” care. For example, annual PAP smears in certain women are considered “low value” and research has shown that the actual benefit compared to the cost is so incrementally small. The PAP test may not be expensive itself but the co-pay, wait time (lost productivity) and physician’s fees-it all adds up to more cost.
Value in healthcare has been broadly defined as quality divided by cost. Thus, more studies that truly analyze the total costs of a treatment or medicine will be welcomed to help front line clinicians make value-based health care decisions with their patients. Even if such studies cannot be analyzed in real time by practitioners, they could be embedded in electronic medical records as a synopsis or bottom line point; these already exist for studies looking at clinical outcomes so expanding to value based outcomes should be simple as well.
I decided to pursue the study looking at the economic impact of a new drug and am preparing for the hospital’s Research Oversight Committee meeting that will oversee the team. As I reviewed the agenda for the meeting, I saw the name of another colleague presenting on a project that is a multicenter study assessing the impact of co-payment reduction for antiplatelet platelet therapy on patient adherence. I realized that there is yet a lot of work to be done in studying these impacts to patients and this is only the tip of the iceberg.